Benefit-risk (PDF files) (May 13, 2013)
— Pharmaceutical Research and Manufacturers of America (PhRMA) letter to FDA expressing support for the agency's proposed benefit-risk assessment framework, including suggesting that the framework be used "to achieve greater consistency" in drug reviews (see BioCentury Extra, Thursday, May 9).
— National Health Council letter to FDA urging that the agency use the proposed benefit-risk assessment framework to "improve predictability for product sponsors" and to provide transparency on the factors that inform the agency's decision making during the review process (see BioCentury Extra, Thursday, May 9).

Drug spending (PDF file) (May 13, 2013)
IMS Institute for Healthcare Informatics report that says per capita spending on medicines in the U.S. fell 3.5% to $898 in 2012 over the prior year due to increased use of generics, lower levels of price increases and reduced spending on new drugs (see BioCentury Extra, Thursday, May 9).

Drug tracking (PDF file) (May 13, 2013)
Text of a discussion draft passed by the U.S. House Energy and Commerce Committee's health subcommittee, which would create a national system for tracking and tracing pharmaceutical products (see BioCentury Extra, Wednesday, May 8).

Emergency contraceptives (PDF file) (May 13, 2013)
Transcript of a U.S. District Court for the Eastern District of New York hearing on May 7 to discuss a request for a stay of an April order compelling FDA to make emergency contraceptives containing levonorgestrel available OTC without age restrictions; a federal judge at the court denied the request on May 10 (see BioCentury Extra, Friday, May 10).

Excipients (PDF files) (May 13, 2013)
EMA draft guideline on the use of phthalates and a draft reflection paper on the use of parabens as excipients in human medicines; both open for consultation until October.

Expanded access (PDF files) (May 13, 2013)
FDA draft guidances composed of Q&As on expanded access to investigational drugs or biologics and the circumstances in which companies can charge for an investigational drug (see BioCentury Extra, Thursday, May 9).

Global regulation (PDF file) (May 13, 2013)
Text of the keynote speech by FDA Commissioner Margaret Hamburg at the Global Health Product Development Forum in Seattle, Wash., in which she said FDA's Murray Lumpkin will serve as a senior fellow at the Bill & Melinda Gates Foundation to work on issues related to regulatory systems and processes in the global setting (see BioCentury Extra, Tuesday, May 7).

Patient-level data (May 13, 2013)
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) online system to request anonymized patient-level data from clinical trials conducted by the pharma.

Sequestration (May 13, 2013)
— NIH notice detailing the effects of sequestration on its FY13 budget (see BioCentury Extra, Wednesday, May 8).
— Statement from Harold Varmus, director of NIH's National Cancer Institute, to grantees in which he says NCI will fund about 1,000 new, competing grants this year to account for sequestration (see BioCentury Extra, Wednesday, May 8).

Biosimilars (PDF file) (May 6, 2013)
EMA draft guidance outlining general principles for developing biosimilars that said biosimilar sponsors who use a reference product approved outside the EU must provide data from analytical studies showing an "acceptable bridge" between the biosimilar, the non-EU reference product and the EU-approved originator reference product (see BioCentury Extra, Thursday, May 2).

Cancer drugs (PDF file) (May 6, 2013)
Text of the Cancer Drug Coverage Parity Act, which was introduced in the U.S. House of Representatives and would require insurers to provide coverage of patient-administered oral and injectable cancer drugs at the same cost to patients as physician-administered IV cancer drugs (see BioCentury Extra, May 3).

Data transparency (PDF files) (May 6, 2013)
EMA final advice from five groups of stakeholders on how to implement the agency's plan to proactively release clinical data for approved drugs, which is slated to go into force on Jan. 1, 2014, including advice from advisory groups on data format; policies for protecting patient confidentiality; good analysis practice; and legal concerns (see BioCentury Extra, Tuesday, May 1).

HIV (May 6, 2013)
U.S. Preventive Services Task Force final statement recommending screening for HIV infection in people ages 15-65 years and in those at increased risk.

Patient network (May 6, 2013)
FDA's Patient Network website through which the public can apply to become a patient representative, comment on FDA regulations, report adverse events and attend FDA webinars (See "FDA's starting lineup," May 6).

Scientific innovation (May 6, 2013)
Text of President Obama's speech at the annual meeting of the National Academy of Sciences in which he said the U.S. "could lose a year, two years of scientific research as a practical matter" due to sequestration cuts (see BioCentury Extra, Monday, April 29).

Product documentation (May 6, 2013)
— Dacogen: Germany's Federal Joint Committee (G-BA) final assessment concluding that Dacogen decitabine has a "marginal" additional benefit to treat newly diagnosed de novo or secondary acute myelogenous leukemia (AML) in patients 65 years and older; from Johnson & Johnson (NYSE:JNJ) and Astex Pharmaceuticals Inc. (NASDAQ:ASTX) (see BioCentury Extra, Thursday, May 2). (PDF file)
— Esbriet: The U.K.'s NICE final guidance recommending the use of Esbriet pirfenidone to treat idiopathic pulmonary fibrosis (IPF) in a subgroup of patients with a forced vital capacity (FVC) of 50-80% of predicted FVC; from InterMune Inc. (NASDAQ:ITMN) and Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507) (PDF file)
— Jakavi: The U.K.'s NICE final appraisal determination (FAD) recommending against the use of Jakavi ruxolitinib to treat disease-related splenomegaly or symptoms in adults with chronic idiopathic myelofibrosis, post-polycythemia vera or essential thrombocythemia myelofibrosis; from Novartis AG (NYSE:NVS; SIX:NOVN) and Incyte Corp. (NASDAQ:INCY). (PDF file)
— Komboglyze: Germany's Federal Joint Committee (G-BA) final assessment concluding that Komboglyze saxagliptin/metformin provides "marginal" additional benefit over sulfonylurea in combination with metformin; from Bristol-Myers Squibb Co. (NYSE:BMY) and AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Thursday, May 2). (PDF file)
— Melblez: Briefing documents for the May 2 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 16-0 that the benefit-risk profile of Melbez Kit chemosaturation system does not support approval to treat unresectable ocular melanoma that is metastatic to the liver; from Delcath Systems Inc. (NASDAQ:DCTH) (see BioCentury Extra, Thursday, May 2). (PDF file)
— Orencia: The U.K.'s NICE final guidance recommending IV Orencia abatacept  in combination with methotrexate to treat rheumatoid arthritis in adults whose disease has responded inadequately to two DMARDs; from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
— Tivozanib: Briefing documents for the May 2 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 13-1 that the benefit-risk profile of tivozanib does not support approval to treat renal cell carcinoma (RCC); from Aveo Pharmaceuticals Inc. (NASDAQ:AVEO), Astellas Pharma Inc. (Tokyo:4503) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) (see BioCentury Extra, Thursday, May 2). (PDF file)
— Xalkori: Germany's Federal Joint Committee (G-BA) final assessment concluding that Xalkori crizotinib has "significant" additional benefit over docetaxel or pemetrexed-containing chemotherapy in patients with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive; from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, May 2). (PDF file)
— Xolair: The U.K.'s NICE final guidance recommending the use of Xolair omalizumab as an add-on to optimized standard therapy for a subgroup of patients ages >=6 years with severe, persistent allergic asthma; from Novartis AG (NYSE:NVS; SIX:NOVN), and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)

Avian influenza (April 29, 2013)
— Declaration by HHS Secretary Kathleen Sebelius of a potential emergency related to the H7N9 avian influenza virus (see BioCentury Extra, Thursday, April 25).
— FDA Emergency Use Authorization letter to the Centers for Disease Control and Prevention for a diagnostic that can detect H7N9 circulating in China (see BioCentury Extra, Thursday, April 25). (PDF file)

Biosimilars (PDF file) (April 29, 2013)
European Commission report stating that biosimilars are increasing competition and helping to stabilize healthcare costs (see BioCentury Extra, Monday, April 22).

Cancer (PDF file) (April 29, 2013)
Pharmaceutical Research and Manufacturers of America (PhRMA) report on medicines in development for leukemia and lymphoma.

Clinical trials (PDF file) (April 29, 2013)
Written evidence received by the U.K. House of Commons' Science and Technology Committee related to questions it asked in December about clinical trials and transparency.

Compounding (PDF file) (April 29, 2013)
Text of a Senate discussion draft of a bill that would make compounding manufacturers subject to stricter regulatory controls by FDA (see BioCentury Extra, Friday, April 26).

Drug development (PDF file) (April 29, 2013)
EMA final concept paper on extrapolation of efficacy and safety in drug development.

Drug monitoring (PDF file) (April 29, 2013)
EMA initial list of medicines that are subject to additional monitoring in the EU and will be required to bear an inverted black triangle on packaging and labeling (see BioCentury Extra, Thursday, April 25).

Economic development (PDF file) (April 29, 2013)
Biotechnology Industry Organization (BIO) bioscience economic development report on legislative priorities, best practices and return on investment.

IQWiG (PDF file) (April 29, 2013)
Germany's Institute for Quality and Efficiency in Health Care (IQWiG) draft revisions, which would update the methods document describing the institute's legal and scientific procedures to reflect its current practices (see BioCentury Extra, Wednesday, April 24).

Medicare (PDF file) (April 29, 2013)
Letter from a bipartisan group of 124 members of the U.S. House of Representatives to CMS Acting Administrator Marilyn Tavenner seeking information on the agency's implementation of 2% sequester cuts to reimbursement for Medicare providers (see BioCentury Extra, Thursday, April 25).

Overall survival (PDF file) (April 29, 2013)
American Society of Clinical Oncology draft recommendations on ranges of overall survival (OS) improvements in Phase III trials that provide a "meaningful benefit" for patients with four types of cancer (see BioCentury Extra, Monday, April 22).

Technology transfer (April 29, 2013)
Collective IP, a web-based search engine of global licensing and commercialization opportunities.

Venture capital (April 29, 2013)
National Venture Capital Association (NVCA) and the Medical Innovation and Competitiveness Coalition report highlighting the contribution of venture capital to medical innovation (see "Plenty supply; shrinking demand," April 29).

Product documentation (April 29, 2013)
—Avastin: The U.K.'s NICE final appraisal determination (FAD) recommending against the use of Avastin bevacizumab to treat recurrent advanced ovarian cancer in combination with gemcitabine and carboplatin; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)

Antibiotics (PDF file) (April 22, 2013)
Infectious Diseases Society of America (IDSA) report on the development status of systemic antibiotics in the U.S. against drug-resistant Gram-negative infections.

Benefit assessments (April 22, 2013)
— List of six groups of drugs that were launched before drug pricing law AMNOG took effect, for which Germany's Federal Joint Committee (G-BA) will conduct benefit assessments (see BioCentury Extra, Thursday, April 18). (PDF file)
— Registration for Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) public meeting on June 21 to discuss issues that arise during benefit assessments when a product's approved indication differs from the indication for which marketing authorization studies were conducted (see BioCentury Extra, Thursday, April 18).

Breast cancer (April 22, 2013)
The U.S. Preventive Services Task Force (USPSTF) draft recommendations on the use of medications to reduce the risk for primary breast cancer in women; comments are due May 13.

Dual-eligibles (PDF file) (April 22, 2013)
Text of the Medicare Drugs Savings Act, which would require manufacturers to pay rebates for drugs sold to "dual-eligibles" — individuals who receive both Medicaid and drug coverage through Medicare (see BioCentury Extra, Tuesday, April 16).

EMA (PDF file) (April 22, 2013)
EMA's annual report for 2012.

Gene patents (PDF file) (April 22, 2013)
Oral arguments heard by the U.S. Supreme Court on Association for Molecular Pathology, et al. v. U.S. PTO, et al., a suit about the eligibility of genes for patenting (April 22, 2013).

Patient community (April 22, 2013)
myTomorrows website, which provides patients and doctors with legal options to gain access to innovative drugs.

Supply chain (PDF file) (April 22, 2013)
Senate draft discussion of legislation that would create a national system for tracking and tracing pharmaceutical products (see BioCentury, Friday, April 19).

Product documentation (April 22, 2013)
— Breo: Briefing documents for the April 17 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted 9-4 that efficacy and safety data for Breo fluticasone furoate/vilanterol support approval of the combination product as maintenance therapy for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD); from Theravance Inc. (NASDAQ:THRX) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (April 22, 2013).
— Dificlir: Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) preliminary benefit assessment concluding that Dificlir fidaxomicin has "no additional benefit" over comparators to treat Clostridium difficile-associated diarrhea (CDAD); from Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) and Astellas Pharma Inc. (Tokyo:4503) (see BioCentury Extra, Monday, April 15). (PDF file)
— Picato: Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) preliminary benefit assessment concluding that Picato ingenol mebutate has "no additional benefit" to treat actinic keratosis; from Leo Pharma A/S (see BioCentury Extra, Monday, April 15). (PDF file)
— Xarelto: The U.K.'s NICE issued final appraisal determination (FAD) recommending the use of Xarelto rivaroxaban to treat pulmonary embolism (PE) and prevent recurrent deep vein thrombosis (DVT) and PE following acute PE in adults; from Bayer AG (Xetra:BAYN) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, April 18). (PDF file)
— Zytiga: Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) preliminary benefit assessment concluding that Zytiga abiraterone has significant additional benefit over "watchful waiting" to treat chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC); from BTG plc (LSE:BTG) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Monday, April 15). (PDF file)

Anemia (April 15, 2013)
U.S. Preventive Services Task Force (USPSTF) draft research plan for screening for iron deficiency anemia during childhood and pregnancy.

Clinical trials (PDF file) (April 15, 2013)
EMA report on patient recruitment and the geographical location of investigator sites in trials supporting MAAs submitted in 2005-11.

Malaria (April 15, 2013)
Letter published in Nature outlining how researchers led by Amyris Inc. (NASDAQ:AMRS) engineered artemisinic acid-producing yeast strains to produce artemisinin, the main ingredient of artemisinin-based combination therapies for malaria (see BioCentury Extra, Thursday, April 11).

NCI (PDF file) (April 15, 2013)
Letter to NIH Director Francis Collins from members of the House of Representatives' Committee on Energy and Commerce requesting information on funds used by NIH and its institutes, including the National Cancer Institute's Office of Communications and Education (OCE), for communications or public relations purposes after an article from The Cancer Letter said OCE spent about $45 million in FY12 (see BioCentury Extra, Friday, April 12).

Patient-focused drugs (April 15, 2013)
— FDA list of 16 disease areas for which the agency will hold the first round of public meetings in FY13-15 under its Patient-Focused Drug Development initiative (see BioCentury Extra, Thursday, April 11). (PDF file)
— Schedule of FDA's patient-focused drug development meetings in FY13-15 (see BioCentury Extra, Thursday, April 11).

PhRMA (PDF files) (April 15, 2013)
— Pharmaceutical Research and Manufacturers of America (PhRMA) report on the role of prescription medicines in the U.S. healthcare system, including effects on quality of life, drug development, spending and costs, treatment gaps, marketing and role in the economy.
— PhRMA's 2013 Biopharmaceutical Research Industry Profile, which said that PhRMA companies invested about $48.5 billion in R&D in 2012.

Product documentation (April 15, 2013)
— Lucentis: The U.K.'s NICE final appraisal determination recommending Lucentis ranibizumab to treat macular edema secondary to central retinal vein occlusion (CRVO) and macular edema secondary to branch retinal vein occlusion (BRVO) for a subset of patients for whom laser photocoagulation has not worked or is not suitable; from Novartis AG (NYSE:NVS; SIX:NOVN) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, April 10). (PDF file)
— Pixuvri: The U.K.'s NICE preliminary appraisal recommending against Pixuvri pixantrone to treat multiply relapsed or refractory aggressive non-Hodgkin's B cell lymphoma; from Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) (see BioCentury Extra, Wednesday, April 10).

Autism (PDF file) (April 8, 2013)
EMA concept paper that recommends drafting a guideline for developing products to treat autism spectrum disorder.

Emergency contraception (PDF files) (April 8, 2013)
U.S. District Court for the Eastern District of New York ruling that ordered FDA to make emergency contraceptives available within 30 days "without a prescription and without point-of-sale or age restrictions;" and FDA solicitation of NDAs for emergency contraception (see "Cover Story", April 8).

Genetic tests (April 8, 2013)
— HHS's Agency for Healthcare Research and Quality (AHRQ) draft technology assessment on genetic tests available for clinical use in common cancers. (PDF file)
— U.S. Preventive Services Task Force (USPSTF) draft guidelines recommending genetic testing for breast cancer early onset (BRCA) mutation status in some women for BRCA-related cancers, including breast or ovarian cancer (see BioCentury Extra, Wednesday, April 3).

Insurance exchanges (April 8, 2013)
HHS proposed rule that would delay until 2015 from Jan. 1, 2014, the implementation of a requirement under the Affordable Care Act that state small business insurance exchanges provide workers with a choice of health insurance plans (see BioCentury Extra, Tuesday, April 2).

Medical countermeasures (April 8, 2013)
Registration for the May 29-31 Regulatory Science Symposium sponsored by FDA's Medical Countermeasures initiative.

Patent box (April 8, 2013)
The U.K. government's "patent box" policy, which provides a reduced U.K. corporate tax rate on profits stemming from qualifying patents (see BioCentury Extra, Monday, April 1).

340B program (PDF file) (April 8, 2013)
Letter from Sen. Chuck Grassley (R-Iowa) asking HHS's Health Resources and Services Administrator Mary Wakefield for information on the agency's oversight of the 340B discount program, which requires manufacturers to give deep discounts on outpatient drugs to hospitals and clinics that provide healthcare to low income and other special populations (see BioCentury Extra, Thursday, April 4).

User fees (PDF files) (April 8, 2013)
FDA draft guidance on user fees and refunds under Medical Device User Fee Amendments of 2012 for PMAs, device BLAs and 510(k) submissions.

Product documentation (PDF files) (April 8, 2013)
—Eliquis: Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) assessment report concluding that Eliquis apixaban has "significant" additional benefit to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors; from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Tuesday, April 2).
— Glivec: India's Supreme Court decision upholding a 2009 ruling by India's Intellectual Property Appellate Board (IPAB) denying a patent for cancer drug Glivec imatinib; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Monday, April 1).

Autism (April 1, 2013)
U.S. Preventive Services Task Force draft research plan for screening for autism spectrum disorder in young children.

Biologics (PDF file) (April 1, 2013)
EMA draft guideline on the declaration of quantitative composition/labeling for biologics that contain modified proteins as active substance.

Biosimilars (PDF files) (April 1, 2013)
— FDA draft guidance that provides standards for biosimilar product sponsors and applicants to follow while requesting, preparing and scheduling formal meetings with the agency (see BioCentury Extra, Friday, March 29).
— Minutes from an Oct. 16-18 meeting of World Health Organization's INN Expert Group, which is considering naming biosimilars with the international nonproprietary name (INN) — the nonproprietary or generic name — of the innovator biologic followed by a coded suffix (see BioCentury Extra, Monday, March 25).

Continuing resolution (PDF file) (April 1, 2013)
Text of a bill (S. Res. 8) passed by the U.S. Senate that would fund the federal government for FY14 (see BioCentury Extra, Monday, March 25).

Healthcare spending (April 1, 2013)
Institute of Medicine interim report on geographic variation in healthcare spending and promotion of high-value care.

Pay-for-delay (PDF file) (April 1, 2013)
Oral arguments heard by the U.S. Supreme Court Justices for Federal Trade Commission v. Actavis Inc., et al., which involves pay-for-delay settlements between branded and generic drug manufacturers (see BioCentury Extra, Tuesday, March 26).  

Product documentation (April 1, 2013)
— Adcira/Cialis: EMA's CHMP revised EPAR updating SPC to include tinnitus as an uncommon adverse event for Adcira/Cialis tadalafil to treat pulmonary arterial hypertension; from Eli Lilly and Co. (NYSE:LLY) and Nippon Shinyaku Co. Ltd. (Tokyo:4516; Osaka:4516).
— Avastin: The U.K.'s NICE final appraisal determination recommending against Avastin bevacizumab for first-line treatment of advanced ovarian cancer in combination with paclitaxel and carboplatin; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
— Celsentri: EMA's CHMP revised EPAR updating SPC to include a warning on reported severe skin and hypersensitivity reactions for Celsentri maraviroc to treat HIV-1 infection; from ViiV Healthcare, a JV between GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Pfizer Inc. (NYSE:PFE).
— Colobreathe: The U.K.'s NICE final guidance recommending the use of Colobreathe colistimethate sodium to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients if nebulized colistimethate, a generic antibiotic, is not tolerated or has not produced an adequate clinical response; from Forest Laboratories Inc. (NYSE:FRX). (PDF file)
— Doribax: EMA's CHMP revised EPAR updating SPC to include the risk of seizures in patients with pre-existing CNS disorders, compromised renal function and at doses higher than 500 mg and include seizures as an adverse drug reaction for Doribax doripenem to treat bacterial infections; from Johnson & Johnson (NYSE:JNJ) and Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507).
— Inlyta: The U.K.'s NICE final appraisal determination recommending against Inlyta axitinib to treat advanced renal cell carcinoma (RCC) in patients who failed treatment with Sutent sunitinib or a cytokine; both from Pfizer Inc. (NYSE:PFE). (PDF file)
— Revolade: The U.K.'s NICE preliminary appraisal recommending the use of Revolade eltrombopag to treat chronic idiopathic thrombocytopenia purpura (ITP) in adults who have had a splenectomy and whose condition is refractory to other treatments or as a second-line treatment in adults who have not had a splenectomy because surgery is contraindicated; from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
— TOBI Podhaler: The U.K.'s NICE final guidance recommending the use of TOBI Podhaler tobramycin to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients if nebulized tobramycin is considered an appropriate treatment; from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
— Xalkori: The U.K.'s NICE preliminary appraisal recommending against Xalkori crizotinib to treat previously treated, anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC); from Pfizer Inc. (NYSE:PFE).
— Victoza: EMA's CHMP revised EPAR updating SPC to include anaphylactic reactions, rash and pruritus as adverse drug reactions for Victoza liraglutide to treat Type II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).

Alzheimer's disease (March 25, 2013)
— FDA draft guidance on developing drugs to treat early stage AD (see "Not So Fast," March 25, 2013). (PDF file)
— New England Journal of Medicine perspective article on regulatory innovation and drug development for early stage AD (see "Not So Fast," March 25, 2013).

Benefit-risk (PDF file) (March 25, 2013)
FDA draft plan to implement a new structured benefit-risk assessment framework to review NDAs of NMEs and original BLAs (see Cover Story).

Biodefense (PDF file) (March 25, 2013)
Presidential Commission for the Study of Bioethical Issues report concluding that the federal government would have to take multiple steps before anthrax vaccine trials with children could be ethically considered.

Biosimilars (March 25, 2013)
Text of a bill signed into state law by Virginia Gov. Robert McDonnell that allows substitution of a biosimilar for an innovator product only if FDA has declared the biosimilar interchangeable for the specific use (see BioCentury Extra, Friday, March 22).

Budget (March 25, 2013)
— Text of H. Res. 25, which was passed by the U.S. House of Representatives and would fund the federal government for FY14. It also seeks to repeal the Affordable Care Act (see BioCentury Extra, Thursday, March 21). (PDF file)
— Text of the temporary budget bill (H.R. 933) passed by the U.S. Senate and House of Representatives, which would allow FDA to spend new and increased user fees for the remainder of FY13 (see BioCentury Extra, Thursday, March 21). (PDF file)
— U.K. Treasury 2013 budget, which includes a provision to reduce the corporate tax rate in April 2015 to 20% from 21% (see BioCentury Extra, Wednesday, March 20). (PDF file)

Drug names (March 25, 2013)
Guidelines from the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (PEI) to limit choices of drug names to prevent misleading and unclear names that can lead to misuse or confusion.

FDA (March 25, 2013)
FDA Commissioner Margaret Hamburg speech to the Massachusetts Biotechnology Council providing an update on the status of the breakthrough drug and biosimilars pathways (see BioCentury Extra, Monday, March 18).

Labels (PDF file) (March 25, 2013)
EMA implementation plan, which said companies that market medicines in the EU that are subject to additional monitoring will be required to include an inverted black triangle on packaging and labeling starting in September (see BioCentury Extra, Monday, March 18).

Liposomal products (PDF file) (March 25, 2013)
EMA reflection paper on data requirements for developing IV liposomal products using a reference innovator liposomal product for comparability.

Medicare (PDF file) (March 25, 2013)
Letter sent to Congress from the Biotechnology Industry Organization (BIO), cancer care providers and physician and patient organizations citing a "flaw" in the way Medicare pays for cancer drugs, exacerbated by a 2% cut in provider payments under budget sequestration, that could cause numerous community cancer clinics to close or curtail treatment (see BioCentury Extra, Friday, March 22).

NIH (March 25, 2013)
Letter to NIH from Sen. Ron Wyden (D-Ore.) requesting a list of medicines that have reached the market as result of NIH research since 1995, when the agency removed the reasonable pricing clause from CRADAs (see BioCentury Extra, Tuesday, March 19).

Orphan drugs (PDF file) (March 25, 2013)
Summary of actions taken at the March 12-13 meeting of EMA's Committee for Orphan Medical Products (COMP).

Pharmacy compounding (March 25, 2013)
Blog post from FDA Commissioner Margaret Hamburg, which said the agency must have new authorities to regulate pharmacy compounding and called for legislation to establish minimum federal standards for firms that compound sterile drug products (see BioCentury Extra, Friday, March 22).

PhRMA (PDF files) (March 25, 2013)
Pharmaceutical Research and Manufacturers of America (PhRMA) report and overview on medicines under development to treat chronic conditions affecting seniors.

Thrombocytopenia (PDF file) (March 25, 2013)
EMA's draft guidelines on the clinical development of products to treat chronic primary immune thrombocytopenia.

Value-based pricing (PDF file) (March 25, 2013)
U.K. government response to a January report from the Health Committee of the U.K. Parliament stating that NICE will be responsible for determining the value of a drug under the country's proposed value-based pricing (VBP) system, which is slated to take effect in 2014 (see BioCentury Extra, Thursday, March 21).

Product documentation (March 25, 2013)
— Afinitor: The U.K.'s NICE preliminary appraisal recommending against use of Afinitor everolimus in combination with exemestane to treat postmenopausal women with hormone receptor-positive, HER2-negative breast cancer that has progressed after treatment with a non-steroidal aromatase inhibitor; from Novartis AG (NYSE:NVS; SIX:NOVN).
— Bretaris/Eklira: Germany's Federal Joint Committee (G-BA) final assessment concluding Bretaris/Eklira Genuiar aclidinium bromide from Almirall S.A. (Madrid:ALM) has "no additional benefit" over Spiriva HandiHaler tiotropium from Boehringer Ingelheim GmbH for chronic obstructive pulmonary disease (COPD) (see BioCentury Extra, Thursday, March 21). (PDF file)
— Esbriet: The U.K.'s NICE final appraisal determination (FAD) recommending the use of Esbriet pirfenidone to treat idiopathic pulmonary fibrosis (IPF) in a subgroup of patients with a forced vital capacity of 50-80% of predicted FVC; from InterMune Inc. (NASDAQ:ITMN) and Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507) (see BioCentury Extra, Wednesday, March 20). (PDF file)
— Inlyta: Germany's Federal Joint Committee (G-BA) final assessment concluding that Inlyta axitinib from Pfizer Inc. (NYSE:PFE) provides a "marginal" additional benefit over Nexavar sorafenib from Bayer AG (Xetra:BAYN) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) to treat advanced renal cell carcinoma in patients who have failed treatment with a cytokine; and no additional benefit over Afinitor everolimus from Novartis AG (NYSE:NVS; SIX:NOVN) to treat advanced RCC in patients who failed prior therapy with Pfizer's Sutent sunitinib (see BioCentury Extra, Thursday, March 21). (PDF file)
— Probuphine: Briefing documents for the March 21 meeting of FDA's Psychopharmacologic Drugs Advisory Committee, which voted 10-4, with one abstention, in support of approval of Probuphine buprenorphine to treat opioid dependence; from Titan Pharmaceuticals Inc. (OTCBB:TTNP) (see BioCentury Extra, Thursday, March 21). (PDF file)
— Revolade: NICE second draft guidance recommending the use of Revolade eltrombopag to treat idiopathic thrombocytopenic purpura (ITP); from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

Biologics (PDF file) (March 18, 2013)
Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing biologic medicines and vaccines under development in the U.S. for over 100 diseases.

Budget (March 18, 2013)
— House Budget Committee's proposed budget resolution for FY14, which proposes a Medicare exchange under which retired citizens born in 1959 or later would have a choice of private plans competing alongside the traditional fee-for-service option (see BioCentury Extra, Tuesday, March 12). (PDF file)
— Senate Budget Committee's proposed budget resolution for FY14, which would eliminate Medicare sequestration cuts and enact a permanent fix to the physician sustainable growth rate (see BioCentury Extra, Wednesday, March 13).
— Text of the Senate Appropriations Committee budget bill, which would give FDA authority to spend new and increased user fees for the remainder of FY13 (see BioCentury Extra, Wednesday, March 13).

Dispute resolution (PDF file) (March 18, 2013)
FDA draft guidance that will update the process to resolve scientific and procedural disputes for drugs and biologics that cannot be resolved at the division level (see BioCentury Extra, Tuesday, March 12).  

EMA (PDF files) (March 18, 2013)
— EMA's Pharmacovigilance Inspectors Working Group work plan for 2013.
— EMA's 2013 work program, in which the agency says it plans to have the capabilities to analyze raw data during the review of MAAs by the end of 2015 (see BioCentury Extra, Wednesday, March 13).

Neonatal infection (PDF file) (March 18, 2013)
NICE draft guidance on antibiotics for preventing and treating early onset neonatal infection.

NICE (PDF file) (March 18, 2013)
Agreement to form the NICE Implementation Collaborative between NHS, healthcare professionals, the life sciences industry and the public to identify barriers to implementing NICE guidance.

Opioids (PDF file) (March 18, 2013)
National Association of Attorneys General (NAAG) letter to FDA Commissioner Margaret Hamburg asking the agency to require that generic versions of prescription opioids be developed using tamper-resistant formulations (see BioCentury Extra, Tuesday, March 12).

PDUFA V (PDF file) (March 18, 2013)
FDA funding announcement on the agency's partnership with the Engelberg Center for Health Care Reform (ECHCR), a think tank that is part of the Brookings Institution, to obtain input on FDA's implementation of its commitments under PDUFA V reauthorization (see BioCentury Extra, Tuesday, March 12).

R&D (March 18, 2013)
— The U.K.’s BioIndustry Association (BIA) report on the Biomedical Catalyst fund, which was launched in 2011 to increase innovation in life sciences in the U.K. (see BioCentury Extra, Monday, March 11).
— The U.K.’s Biomedical Catalyst fund list of recipients that received L47.2 million ($70.5 million) (see BioCentury Extra, Monday, March 11).

Product documentation (March 18, 2013)
— Eylea: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment concluding that Eylea aflibercept has "no additional benefit" over the comparator requested by Germany's Federal Joint Committee (G-BA) to treat wet age-related macular degeneration (AMD); from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Bayer AG (Xetra:BAYN) (see BioCentury Extra, Friday, March 15). (PDF file)
— Forxiga: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that Type II diabetes drug Forxiga dapagliflozin provides "no additional benefit" vs. four sets of comparators requested by Germany's Federal Joint Committee (G-BA); from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMY) (see "Disarmamentarium in Germany," March 18). (PDF file)
— Lyxumia: EMA's CHMP EPAR for Lyxumia lixisenatide to treat adults with Type II diabetes; from Zealand Pharma A/S (CSE:ZEAL) and Sanofi (Euronext:SAN; NYSE:SNY).
— Metasin test: The U.K.'s NICE draft guidance recommending against use of Metasin test to detect sentinel lymph node metastases in patients with early invasive breast cancer who have a sentinel lymph node biopsy and in whom axillary lymph node dissection will be considered; from TIB Molbiol GmbH.
— Selincro: EMA's CHMP EPAR for Selincro nalmefene to reduce alcohol consumption in adults with alcohol dependence; from Biotie Therapies Corp. (HSE:BTH1V) and H. Lundbeck A/S (CSE:LUN).
— Temodal: EMA's CHMP revised EPAR updating SPC to include reported cases of fatal respiratory failure and include pulmonary fibrosis as an adverse drug reaction for Temodal temozolomide to treat malignant glioma; from Merck & Co. Inc. (NYSE:MRK).

Biosimilars (PDF files) (March 11, 2013)
EMA final guidelines on biosimilar versions of multiple sclerosis (MS) drug interferon (IFN) beta and products containing recombinant human follicle stimulating hormone (r-hFSH) (see BioCentury Extra, Wednesday, March 6).

Brain research (March 11, 2013)
Perspective piece published in Science that said the Brain Activity Map (BAM) consortium, which is aiming to measure and model all neural activity within the brain, should be funded by a partnership between federal and private organizations (see SciBX: Science-Business eXchange, March 7).

Budget (PDF file) (March 11, 2013)
Text of the continuing resolution (H.R. 933), which would fund the federal government through Sept. 30 and allow FDA to spend increased medical device user fees and fees collected under the Generic Drug User Fee Act (see BioCentury, March 11).

Drug spending (March 11, 2013)
Express Scripts Holding Co. (NASDAQ:ESRX) report that said U.S. spending on traditional prescription drugs decreased in 2012 for the first time in more than 20 years but was offset by an 18.4% increase in spending on specialty prescription drugs (see BioCentury Extra, Tuesday, March 5).

Lupus (PDF file) (March 11, 2013)
EMA draft guidelines for the development of therapeutics for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) (see BioCentury Extra, Wednesday, March 6).

PAHPA (PDF file) (March 11, 2013)
Text of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307), which would reauthorize for an additional five years provisions of PAHPA and the act that created HHS's Project Bioshield (see BioCentury Extra, Tuesday, March 5).

Rare diseases (March 11, 2013)
Research projects focused on rare diseases that received EUR 144 million ($187 million) in funding from the European Commission's Framework Programme 7 (see BioCentury Extra, Wednesday, March 6).

Product documentation (March 11, 2013)
— Fycompa: Germany's Federal Joint Committee (G-BA) final benefit assessment concluding Fycompa perampanel has no additional benefit over comparators to treat partial onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Thursday, March 7). (PDF file)
— Jakavi: Germany's Federal Joint Committee (G-BA) final benefit assessment concluding Jakavi ruxolitinib has a "marginal" additional benefit for its approved indications of chronic myelofibrosis, post-polycythemia vera or essential thrombocythemia myelofibrosis; from Incyte Corp. (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, March 7). (PDF file)
— Kadcyla: FDA documentation on the review of Kadcyla ado-trastuzumab emtansine, which is approved to treat HER2-positive metastatic breast cancer in patients who have received prior treatment with Herceptin trastuzumab and a taxane-based chemotherapy regimen; both from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury, March 11).
— Lucentis: NICE final guidance recommending Lucentis ranibizumab to treat visual impairment due to diabetic macular edema (DME) in patients with central retinal thickness of at least 400 um; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
— RD-100i OSNA system: NICE draft guidance recommending RD-100i OSNA system to detect sentinel lymph node metastases in patients with early invasive breast cancer who have a sentinel lymph node biopsy and in whom axillary lymph node dissection will be considered; from Sysmex Corp. (Tokyo:6869; Osaka:6869).
— Xolair: NICE final appraisal determination (FAD) recommending use of Xolair omalizumab as an add-on to optimized standard therapy for a subgroup of patients ages six years or older with severe, persistent allergic asthma; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Wednesday, March 6). (PDF file)

China (March 4, 2013)
China's State Food and Drug Administration (SFDA) proposed reforms to improve the country's drug review and approval processes, including giving more priority to therapeutics with IP protection and speeding up review periods, particularly for drugs developed in China by Chinese companies (see BioCentury Extra, Wednesday, Feb. 27).

Drug pricing (PDF file) (March 4, 2013)
India's Committee on Price Negotiations for Patented Drugs report recommending the government adopt a per capita income adjusted reference pricing system for prescription drugs (see BioCentury Extra, Wednesday, Feb. 27).

Financial disclosures (PDF file) (March 4, 2013)
FDA guidance on interpreting and complying with regulations governing financial disclosure by clinical investigators.

Fixed-dose combinations (PDF file) (March 4, 2013)
EMA concept paper on the need to revise the dossier requirements in the guideline for clinical development of fixed-dose combination products.

Heart failure (PDF file) (March 4, 2013)
EMA concept paper on the need to revise guidelines for clinical development of products to treat heart failure.

HHS (March 4, 2013)
Statement from Sen. Chuck Grassley (R-Iowa) on his opposition to the nomination of William Schultz as HHS's general counsel due to the agency's "refusal to respond to [his] oversight requests" (see BioCentury Extra, Tuesday, Feb. 26).

Jobs (PDF file) (March 4, 2013)
Australian government plan proposing several policies to increase jobs in Australia, including commitments to increase funding for VCs and to improve clinical trials (see BioCentury Extra, Wednesday, Feb. 27).

Muscular dystrophy (PDF file) (March 4, 2013)
EMA draft guidelines on the development of products to treat Duchenne and Becker muscular dystrophy

PAHPA (PDF file) (March 4, 2013)
Text of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307), which was unanimously passed by the Senate and would reauthorize provisions of PAHPA and the act that created HHS's Project Bioshield (see BioCentury Extra, Friday, March 1).

Patient access schemes (PDF file) (March 4, 2013)
U.K.'s Department of Health tips for companies considering whether to submit a patient access scheme proposal in England.

Pediatric safety (PDF file) (March 4, 2013)
FDA final rule amending regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products.

Pharmacovigilance (PDF file) (March 4, 2013)
Minutes from the Jan. 7-10 meeting of EMA's Pharmacovigilance Risk Assessment Committee (PRAC).

Reimbursement (PDF file) (March 4, 2013)
HHS's Office of the Inspector General (OIG) report recommending CMS change its payment methodology for Part B infusion drugs administered with durable medical equipment to more closely align with that of other Part B drugs.

Securities Fraud (PDF file) (March 4, 2013)
U.S. Supreme Court decision in Amgen Inc. v. Connecticut Retirement Plans and Trust Funds ruling 6-3 that shareholders may sue Amgen Inc. (NASDAQ:AMGN) as a class in a securities fraud case alleging the biotech misled investors about the safety of anemia drugs Aranesp darbepoetin alfa and Epogen epoetin alfa (see BioCentury Extra, Wednesday, Feb. 27).

Trypsin (PDF file) (March 4, 2013)
EMA draft guidelines on the use of porcine trypsin in manufacturing biologics.

Product documentation (March 4, 2013)
— Adasuve: EMA's CHMP EPAR for Adasuve Staccato loxapine to treat mild to moderate agitation in adults with schizophrenia or bipolar disorder; from Alexza Pharmaceuticals Inc. (NASDAQ:ALXA).
— Adcetris: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) assessment estimating Adcetris brentuximab vedotin to treat relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) and relapsed or refractory CD30-positive Hodgkin's lymphoma will cost the German statutory health insurance funds (GKV) EUR 6.1-EUR 53.4 million ($8.1-$70.6 million) per year; from Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Friday, March 1). (PDF file)
— Bydureon: FDA review documents for Bydureon exenatide to treat Type II diabetes; from Bristol-Myers Squibb Co. (NYSE:BMY) and Alkermes plc (NASDAQ:ALKS) (see "Bydureon back story," March 4, 2013).
— Pixuvri: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment concluding that Pixuvri pixantrone provides "no additional benefit" over comparators to treat multiply relapsed or refractory aggressive non-Hodgkin's B cell lymphoma; from Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) (see BioCentury Extra, Friday, March 1). (PDF file)
— Trajenta: Germany's Federal Joint Committee (G-BA) preliminary benefit assessment concluding Trajenta linagliptin as add-on therapy to insulin provides "no additional benefit" over human insulin and metformin to treat Type II diabetes; from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Friday, March 1). (PDF file)

Asthma (February 25, 2013)
NICE quality standard for diagnosing and treating asthma in people aged 12 months and older.

Breakthrough Prize (February 25, 2013)
Recipients of the $3 million Breakthrough Prize in Life Sciences from the Breakthrough Prize in Life Sciences Foundation (see BioCentury Extra, Wednesday, Feb. 20).

Essential health benefits (PDF file) (February 25, 2013)
HHS final rule that includes language that will increase the number of drugs eligible for reimbursement by insurers under the Affordable Care Act's essential health benefits requirements (see BioCentury Extra, Wednesday, Feb. 20).

HCV (PDF file) (February 25, 2013)
FDA draft guidance for submitting HCV resistance data.

Patents (PDF files) (February 25, 2013)
— Oral arguments heard by the U.S. Supreme Court in Bowman v. Monsanto, which involves the rights of patent holders to prevent copying of self-replicating inventions (see "Defending Self-replication," Monday, Feb. 25).
— Agreement between 22 EU member states to establish the Unified Patent Court (UPC), which will have exclusive jurisdiction over litigation including the infringement and validity of existing European patents and future unitary European patents (see BioCentury Extra, Tuesday, Feb. 19).

Pathogens (PDF files) (February 25, 2013)
— The White House's Office of Science and Technology Policy (OSTP) proposed rule that would establish new oversight requirements for federally funded research that involves 15 dangerous agents and toxins, including avian influenza A (H5N1); comments due April 23 (see BioCentury Extra, Thursday, Feb. 21).
— HHS framework to guide the agency's funding decisions for research proposals that have the potential to generate highly pathogenic H5N1 viruses that are transmissible among mammals (see BioCentury Extra, Thursday, Feb. 21).

R&D (PDF file) (February 25, 2013)
White House Office of Science and Technology Policy (OSTP) memorandum that directs federal agencies with more than $100 million in R&D expenditures to develop a plan to make published results of federally funded research freely available to the public within one year of publication (see BioCentury Extra, Friday, Feb. 22).

Product documentation (February 25, 2013)
— IHC4 immunohistochemistry test: NICE draft guidance recommending the use of IHC4 immunohistochemistry test only in the research setting to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative early breast cancer; from Royal Marsden Hospital and Queen Mary University London (see BioCentury Extra, Tuesday, Feb. 19). (PDF file)
— MammaPrint: NICE draft guidance recommending use of MammaPrint only in the research setting to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative early breast cancer; from Agendia B.V. (see BioCentury Extra, Tuesday, Feb. 19). (PDF file)
— Mammostrat: NICE draft guidance recommending use of Mammostrat only in the research setting to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative early breast cancer; from the Clarient Inc. subsidiary of General Electric Co. (NYSE:GE) (see BioCentury Extra, Tuesday, Feb. 19). (PDF file)
— Oncotype DX: NICE draft guidance recommending use of Oncotype DX to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative early breast cancer who are at intermediate risk of distant recurrence; from Genomic Health Inc. (NASDAQ:GHDX) (see BioCentury Extra, Tuesday, Feb. 19). (PDF file)
— Ryzodeg: EMA's CHMP EPAR for Ryzodeg insulin degludec/insulin aspart to treat Type I and II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).
— Trajenta: Germany's Federal Joint Committee (G-BA) final benefit assessment that concluded diabetes drug Trajenta linagliptin provides no additional benefit over sulfonylurea; from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Thursday, Feb. 21). (PDF file)
— Tresiba: EMA's CHMP EPAR for Tresiba insulin degludec to treat Type I and II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).  

Biosimilars (PDF file) (February 18, 2013)
Comments from the Washington Legal Foundation submitted in support of a 2012 Citizen's Petition from Abbott Laboratories (NYSE:ABT) urging FDA to defer all work on regulatory applications for biosimilars that reference biologics for which a BLA was submitted prior to March 23, 2010 (see BioCentury Extra, Thursday, Feb. 14).

Budget (PDF file) (February 18, 2013)
Congressional Budget Office budget and economic outlook report for FY13-FY23 (see BioCentury Extra, Wednesday, Feb. 13).

Cancer care (February 18, 2013)
Institute of Medicine (IOM) summary of an October 2012 cancer care workshop in which stakeholders made recommendations to improve the affordability and quality of cancer care (see BioCentury Extra, Tuesday, Feb. 12).

Drug pricing (PDF files) (February 18, 2013)
— Letter from a group coordinated by the Alliance for a Just Society to President Obama and Congress urging lawmakers to allow Medicare and Medicaid to negotiate prices for prescription drugs (see BioCentury Extra, Thursday, Feb. 14).
— Center for Economic and Policy Research (CEPR) report that estimated the federal government could save up to $541.3 billion and state governments up to $72.7 billion over the next 10 years if Medicare and Medicaid programs were able to negotiate drug prices (see BioCentury Extra, Thursday, Feb. 14).

Drug shortages (PDF file) (February 18, 2013)
FDA request for public comments on questions related to drug and biological product shortages.

EMA (PDF file) (February 18, 2013)
Minutes of the Nov. 30, 2012 meeting of the EMA Human Scientific Committee's Working Party and Patients and Consumers Working Party (PCWP).

Indian clinical trials (PDF files) (February 18, 2013)
— Regulations issued by India's Ministry of Health and Family Welfare requiring clinical trial sponsors to provide compensation to patients who suffer injury or death during or as a result of the trial (see BioCentury Extra, Tuesday, Feb. 12).
— Regulations issued by India's Ministry of Health and Family Welfare specifying that clinical trials must be registered and conducted under good clinical practice guidelines (see BioCentury Extra, Tuesday, Feb. 12).

Jobs (February 18, 2013)
Text of the Startup Act 3.0, which would change tax requirements for startup investments and amend visa regulations in an effort to create new businesses and jobs (see BioCentury Extra, Wednesday, Feb. 13).

Pharmacovigilance (February 18, 2013)
— Drug Consumption Database launched by the PROTECT project — a public-private partnership coordinated by EMA — which includes data sources on drug consumption in Europe.
— PROTECT ADR Database launched by the PROTECT project, which includes all adverse drug reactions listed for centrally authorized products in the EU.

REMS (PDF file) (February 18, 2013)
HHS's Office of the Inspector General (OIG) report that says FDA does not have comprehensive data from sponsor assessments to determine whether REMS are meeting their goals (see BioCentury Extra, Wednesday, Feb. 13).

Specialty drugs (PDF file) (February 18, 2013)
Avalere Health LLC report on the implications of changes to Medicaid reimbursement programs on specialty drugs.

State of the Union (February 18, 2013)
— Text of President Obama's 2013 State of the Union speech in which he proposed cutting government payments to drug companies to reduce Medicare costs while also calling for increasing taxpayer support for academic biomedical research (see BioCentury Extra, Wednesday, Feb. 13).
— Report by the not-for-profit Battelle Memorial Institute cited in President Obama's 2013 State of the Union Speech on the economic impact of the human genome project (see BioCentury Extra, Wednesday, Feb. 13).

Therapeutic proteins (PDF file) (February 18, 2013)
FDA draft guidance outlining and recommending adoption of a risk-based approach to evaluating and mitigating immune responses to therapeutic proteins.

340B (PDF file) (February 18, 2013)
— Report issued by the Biotechnology Industry Organization (BIO) and other industry groups on the 340B drug discount program that identifies unintended consequences for patients and recommends Congress conduct a thorough examination of the program.

Product documentation (February 18, 2013)
— Diane 35: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) call for stakeholder feedback on Diane 35 cyproterone/ethinylestradiol from Bayer AG (Xetra:BAYN) and its generic versions as part of the committee's ongoing review of products containing cyproterone acetate and ethinylestradiol.
— Dotarem: Briefing documents for the Feb. 14 meeting of the Medical Imaging Drugs Advisory Committee, which unanimously recommended approval of Dotarem gadoterate meglumine to detect and visualize areas with disruption of the blood-brain barrier and/or abnormal vascularity in brain, spine and associated tissues in adults and pediatric patients; from Guerbet S.A. (Euronext:GBT). (PDF file)
— Jakavi: NICE draft guidance recommending against the use of Jakavi ruxolitinib to treat disease-related splenomegaly or symptoms in adults with chronic idiopathic myelofibrosis, post-polycythemia vera or essential thrombocythemia myelofibrosis; from Incyte Corp. (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Tuesday, Feb. 12).

Alzheimer's disease (PDF file) (February 11, 2013)
FDA draft guidance on clinical trial design for products to treat early AD (see BioCentury Extra, Thursday, Feb. 8). 

Biosimilars (February 11, 2013)
Text of identical House (PDF file) and Senate bills rejected by Mississippi legislators, which sought to restrict when pharmacists may dispense a biosimilar in place of an innovator product (see BioCentury Extra, Friday, Feb. 8).

Clinical trials (February 11, 2013)
FDA notice on extending to Feb. 15 the comment period on draft guidance (PDF file) outlining enrichment strategies to improve the efficiency of clinical trials (see BioCentury Extra, Monday, Dec. 17, 2012).

FDA (February 11, 2013)
— FDA notice for requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee; device panels of the Medical Devices Advisory Committee; the National Mammography Quality Assurance Advisory Committee; and the Technical Electronic Products Radiation Safety Standards Committee.
— FDA's FDA Voice blog post from Anne Pariser, associate director for rare diseases at FDA's Center for Drug Evaluation and Research, who said that for all new drugs approved during 2010-12, the average clinical development time was more than three years faster when a pre-IND meeting was held with FDA than it was for drugs approved without a meeting.

Generics (February 11, 2013)
—Text of the Preserve Access to Affordable Generics Act (S. 214), which seeks to prohibit "pay for delay" deals between branded and generic companies to postpone the launch of generic drugs (see BioCentury Extra, Thursday, Feb. 8).
— U.S. Federal Trade Commission report, which said that 40 of the 140 final resolutions of patent disputes between a brand and a generic during fiscal year 2012 may have involved pay-for-delay payments (see BioCentury Extra, Thursday, Feb. 8). (PDF file)

Labeling (February 11, 2013)
FDA request for comments and information on the proposed implementation of the agency's Prescription Drug Labeling Improvement and Enhancement Initiative.

Medicare (PDF file) (February 11, 2013)
Proposal introduced by Republicans in the U.S. House of Representatives Energy and Commerce and Ways and Means committees to repeal Medicare's sustainable growth rate, which Medicare uses to calculate physician payment rates (see BioCentury Extra, Friday, Feb. 8).

Myocardial infarction (PDF file) (February 11, 2013)
The U.K.'s NICE draft clinical guideline on the acute management of ST-elevation myocardial infarction (STEMI).

NIH partnerships (February 11, 2013)
NIH's National Center for Advancing Translational Sciences (NCATS) and the National Human Genome Research Institute (NHGRI) notice seeking partners to collaborate in final state of preclinical testing of two series of small molecule compounds: non-inhibitory chaperones of glucocerebrosidase (GBA; GCase), which are in development for Gaucher's disease and Parkinson's disease (PD); and agonists of relaxin-insulin-like family peptide receptor 1 (RXFP1; LGR7), which are in development for heart failure and fibrosis (see BioCentury Extra, Friday, Feb. 8).

Safety (PDF file) (February 11, 2013)
International Conference on Harmonization draft guideline on standards for photosafety evaluation of pharmaceuticals.

Therapeutic proteins (PDF file) (February 11, 2013)
FDA draft guidance on evaluating and mitigating immune responses to therapeutic proteins.

Tuberculosis (February 11, 2013)
Communique from the second BRICS Health Ministers' meeting, comprising Brazil, Russia, India, China and South Africa, agreeing to collaborate to develop capacity and infrastructure to reduce the prevalence and incidence of tuberculosis, including multidrug-resistant TB (see BioCentury Extra, Monday, Feb. 4).

Urinary incontinence (PDF file) (February 11, 2013)
The U.K.'s NICE draft of updated clinical guidelines for managing urinary incontinence in women.

Product documentation (February 11, 2013)
— Ampligen: FDA explanation and Q&A of its decision to issue a complete response letter for Ampligen rintatolimod to treat chronic fatigue syndrome (CFS); from Hemispherx Biopharma Inc. (NYSE-M:HEB) (see BioCentury Extra, Tuesday, Feb. 5).
— Kalydeco: Germany's Federal Joint Committee (G-BA) final assessment of Kalydeco ivacaftor, which said that the cystic fibrosis drug provides a "significant" degree of additional benefit for patients older than 12 and a "marginal" degree of benefit for patients ages 6-11 years; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) (see BioCentury Extra, Thursday, Feb. 7). (PDF file)
— Krystexxa: The U.K.'s NICE preliminary appraisal recommending against the use of Krystexxa pegloticase to treat severe chronic tophaceous gout in adult patients; from Savient Pharmaceuticals Inc. (NASDAQ:SVNT).

ALS (February 4, 2013)
FDA notice of a Feb. 25 public hearing to obtain stakeholder input on the needs and preferences of amyotrophic lateral sclerosis patients, as well as input on how to be responsive to those needs (see BioCentury Extra, Wednesday, Jan. 30).

Biosimilars (PDF file) (February 4, 2013)
EMA draft guidelines on developing biosimilar low-molecular weight heparins (LMWH), which would revise 2008 guidelines to note that in an "exceptional scenario" sponsors for some biosimilars may not be required to conduct a clinical efficacy trial (see BioCentury Extra, Friday, Feb. 1).

CMS (February 4, 2013)
— Centers for Medicare & Medicaid Services' final version of the "sunshine" rule, which requires medical manufacturers to publicly report payments to physicians or teaching hospitals (see BioCentury Extra, Friday, Feb. 1). (PDF file)
—Public comments received by CMS asking the agency to limit use of its coverage with evidence development (CED) mechanism to off-label uses of FDA-approved drugs and biologics (see BioCentury Extra, Tuesday, Jan. 29).

Diabetes (February 4, 2013)
EMA notice for a Feb. 25 public workshop on pediatric clinical trials for Type II diabetes.

Drug delivery (February 4, 2013)
EMA and Japan's Ministry of Health, Labor and Welfare (MHLW) notice of public consultation on a joint reflection paper on medicines delivered using nano-sized block copolymer micelles.

Drug discounts (PDF file) (February 4, 2013)
Letter from six Republicans lawmakers to HHS's Health Resources and Services Administration seeking details on the agency's audits of the eligibility of healthcare entities for the 340B drug discount program (see BioCentury Extra, Friday, Feb. 1).

Drug-induced liver injury (February 4, 2013)
FDA notice of a March 20-21 public meeting to discuss how best to detect and assess the severity, extent and likelihood of drug causation for drug-induced liver injury (see BioCentury Extra, Monday, Jan. 28).

EMA (February 4, 2013)
EMA notice for volunteers from the pharmaceutical industry to help test new features on the agency's main website.

FDA (PDF file) (February 4, 2013)
FDA list of new and revised draft guidances that the agency's Center for Drug Evaluation and Research (CDER) plans to publish this year, which does not include guidance on the interchangeability of biosimilars (see BioCentury Extra, Thursday, Jan. 31).

Gene/Cell therapy (February 4, 2013)
— European Directorate for the Quality of Medicines & Healthcare (EDQM) and EMA notice of an April 3 joint meeting on raw materials used for the production of cell-based and gene-therapy products.
— Germany's Federal Court of Justice ruling that a patent covering isolated and purified neural precursor cells produced from human embryonic stem cells (hESC) is invalid insofar as it covers precursor cells from hESCs that were gained through the destruction of human embryos, but remains valid so long as hESCs are gained through methods that do not require destruction of embryos. (PDF file)

Immigration (PDF files) (February 4, 2013)
— Text of the Immigration Innovation Act of 2013 introduced by a bipartisan group of U.S. senators, which would eliminate the cap on the number of visas granted to U.S.-educated foreign students who graduate with a master's degree or doctorate in science, technology, engineering or mathematics (STEM) (see BioCentury Extra, Wednesday, Jan. 30).
— U.S. Immigration and Customs Enforcement's updated list of STEM-designated degree programs, which now includes life science degrees (see BioCentury Extra, Wednesday, Jan. 30).

Patents (February 4, 2013)
— U.S. Patent and Trademark Office (PTO) notice of a March 21 public hearing to obtain stakeholder input on the international harmonization of patent law and questionnaire related to input on the grace period, publication of applications, the treatment of conflicting applications and prior user rights (see BioCentury Extra, Friday, Feb. 1).
— PTO patent term calculator that enables the public to estimate the expiration date of a utility, plant or design patent.

PCORI (February 4, 2013)
Patient-Centered Outcomes Research Institute notice seeking applicants for its first four advisory panels, which the institute said will provide scientific or technical expertise and help it identify and prioritize research questions for funding (see BioCentury Extra, Wednesday, Jan. 30).

Pharmacogenomics (PDF file) (February 4, 2013)
FDA guidance on clinical pharmacogenomics, which includes recommendations on evaluating compounds in early clinical trials and labeling.

Product documentation (February 4, 2013)
— Avastin: NICE draft guidance recommending against the use of Avastin bevacizumab to treat recurrent advanced ovarian cancer in combination with gemcitabine and carboplatin; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, Jan. 31).
— Bronchitol: Briefing documents for the Jan. 30 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted 14-0 against approval of Bronchitol mannitol to improve pulmonary function in cystic fibrosis (CF) patients six years of age and older; from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) (see BioCentury Extra, Wednesday, Jan. 30).
— Cimzia: EMA's CHMP revised EPAR updating SPC to include information related to hypersensitivity reactions occurring after the first injection of Cimzia certolizumab to treat rheumatoid arthritis (RA); from UCB Group (Euronext:UCB) and Astellas Pharma Inc. (Tokyo:4503).
— Forxiga: NICE draft guidance that was "unable to recommend" Forxiga dapagliflozin as an add-on therapy to treat Type II diabetes; from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Thursday, Jan. 31).
— Inovelon: EMA's CHMP revised EPAR updating SPC to mention drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome to the serious hypersensitivity reaction warning for Inovelon rufinamide to treat seizures associated with Lennox-Gastaut syndrome; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Novartis AG (NYSE:NVS; SIX:NOVN).
— Krystexxa: EMA's CHMP EPAR for Krystexxa pegloticase to treat severe chronic tophaceous gout in adult patients; from Savient Pharmaceuticals Inc. (NASDAQ:SVNT).
— Sycrest: EMA's CHMP revised EPAR updating SPC to include salivary hypersecretion as an adverse event for Sycrest asenapine to treat moderate to severe manic episodes associated with bipolar I disorder; from Merck & Co. Inc. (NYSE:MRK).
— Viagra: EMA's CHMP revised EPAR updating SPC to include penile hemorrhage, hematospermia and hematuria as adverse drug reactions with an uncommon frequency for Viagra sildenafil to treat erectile dysfunction; from Pfizer Inc. (NYSE:PFE).

Drug exclusivity (January 28, 2013)
Citizen's Petition from Gilead Sciences Inc. (NASDAQ:GILD) to FDA asking the agency to recognize five-year exclusivity for its HIV drug Stribild elvitegravir/cobicistat/emtricitabine/tenofovir as well as all new active moieties, whether first approved as a single agent or in a fixed-dose combination with other previously approved active moieties (see BioCentury Extra, Thursday, Jan. 24).

H5N1 research (January 28, 2013)
Letter published in Science and Nature from a group of influenza virus researchers who ended a voluntary pause on research on the transmissibility of highly pathogenic avian influenza A (H5N1) in mammals concluding that the benefits of H5N1 transmission research outweigh the risks (see BioCentury Extra, Wednesday, Jan. 23).

Humanitarian Use Device (PDF file) (January 28, 2013)
FDA guidance for preparing and submitting Humanitarian Use Device (HUD) designation requests to the agency.

Hydrocodone (PDF file) (January 28, 2013)
Briefing documents for the Jan. 24-25 of FDA's Drug Safety and Risk Management Advisory Committee, which voted 19-10 that the U.S. Drug Enforcement Administration (DEA) should reschedule hydrocodone combination products as class II scheduled drugs, where class I indicates the highest potential for abuse and class V the lowest; hydrocodone combination products are scheduled as class III drugs, while pure hydrocodone is a class II scheduled drug (see BioCentury Extra, Friday, Jan. 25).

PAHPA (PDF file) (January 28, 2013)
Text of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307), which would reauthorize for an additional five years provisions of PAHPA, as well as the act that created HHS's Project Bioshield (see BioCentury Extra, Wednesday, Jan. 23).

Pharmacovigilance (PDF file) (January 28, 2013)
EMA guideline on good pharmacovigilance practices' module XV, which relates to safety communication in the EU.

Postmarketing requirements (PDF file) (January 28, 2013)
FDA draft guidance to determine the type of marketing submission that may be required for postapproval changes to a combination product approved under a BLA, NDA or PMA.

Product documentation (January 28, 2013)
— Amyvid: EPAR from EMA's CHMP for Amyvid florbetapir as a PET imaging agent to estimate beta amyloid neuritic plaque density in patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline; from Eli Lilly and Co. (NYSE:LLY).
— Colobreathe: The U.K.'s NICE final appraisal determination (FAD) recommending Colobreathe colistimethate sodium to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients if nebulized colistimethate, a generic antibiotic, is not tolerated; from Forest Laboratories Inc. (NYSE:FRX) (see BioCentury Extra, Thursday, Jan. 24). (PDF file)
— Eliquis: The U.K.'s NICE FAD recommending the use of Eliquis apixaban to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors; from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Tuesday, Jan. 22). (PDF file)
— Iluvien: The U.K.'s NICE final guidance recommending against the use of Iluvien fluocinolone acetonide intravitreal implant to treat chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies; from Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA). (PDF file)
— Javlor: The U.K.'s NICE final guidance recommending against Javlor vinflunine to treat advanced or metastatic transitional cell carcinoma of the urothelial tract that has progressed following prior treatment; from Laboratoires Pierre Fabre S.A. (PDF file)
— Striverdi Respimat: Briefing documents for the Jan. 29 meeting of the Pulmonary Allergy Drugs Advisory Committee to discuss an NDA for Striverdi Respimat olodaterol to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD); from Boehringer Ingelheim GmbH (see BioCentury Extra, Friday, Jan. 25). (PDF file)
— TOBI Podhaler: The U.K.'s NICE FAD recommending TOBI Podhaler inhaled tobramycin powder to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in CF patients; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Jan. 24). (PDF file)
— Zytiga: EMA's CHMP revised EPAR updating SPC to include warnings related to hyperglycemia, use with chemotherapy and potential risks of anemia and sexual dysfunction and add a contraindication in patients with severe hepatic impairment for Zytiga abiraterone to treat metastatic castration-resistant prostate cancer (CRPC); from BTG plc (LSE:BTG) and Johnson & Johnson (NYSE:JNJ).

Acute heart failure (PDF file) (January 21, 2013)
EMA concept paper on the need for a pediatric addendum to the guideline for clinical investigation of medicinal products to treat acute heart failure.

Advanced therapies (PDF file) (January 21, 2013)
Summary of actions taken at the Jan. 10-11 meeting of EMA's Committee for Advanced Therapies (CAT).

Breast cancer (PDF file) (January 21, 2013)
The U.K.'s NICE updated draft guidance on familial breast cancer, which includes provisional recommendations relating to genetic testing and patients recently diagnosed with breast cancer with a family history of the disease.

Cell therapy (January 21, 2013)
The U.K.'s Cell Therapy Catapult (CTC) database of 21 ongoing cell therapy clinical trials in the U.K.

Comparative effectiveness (January 21, 2013)
Blog posting from Robert Temple, deputy center director for clinical science at FDA's Center for Drug Evaluation and Research, in which he said he "would like to see more" comparative effectiveness trials that randomize non-responders to a drug to receive both that drug and an alternative drug (see BioCentury Extra, Friday, Jan. 18).

FDA (January 21, 2013)
— FDA notice of a Feb. 4-5 public hearing to obtain input on creating a new approval pathway for therapeutics for limited, well-defined subpopulations of patients with serious or life-threatening conditions (see BioCentury Extra, Monday, Jan. 14). (PDF file)
— FDA Small Business Chronicles newsletter on Breakthrough Therapy Designation, a new program that commits FDA to collaborate with a sponsor to enable expedited development and review of compounds for serious or life-threatening diseases that show substantial improvements over existing treatments in early clinical trials.

Immunization (January 21, 2013)
Institute of Medicine (IOM) report that found no evidence of major safety concerns associated with adherence to the childhood immunization schedule.

Medicaid (PDF file) (January 21, 2013)
U.S. Centers for Medicare & Medicaid Services (CMS) proposed rule to establish higher cost-sharing levels for non-preferred drugs covered by Medicaid (see BioCentury Extra, Tuesday, Jan. 15).

Medicinal errors (PDF file) (January 21, 2013)
EMA draft program for the Feb. 28-March 1 workshop on mistakes in the processes of prescribing, dispensing, administering or monitoring medicinal products in clinical practice.

NMEs (PDF file) (January 21, 2013)
Pharmaceutical Research and Manufacturers of America (PhRMA) report, which said there were 5,408 NMEs in clinical development as of December 2011 (see BioCentury Extra, Thursday, Jan. 17).

Parkinson's disease (January 21, 2013)
NIH's Parkinson's Disease Biomarkers Program (PDBP) to support the discovery and development of diagnostic and progression biomarkers for PD and list of nine teams whose projects have received funding from the program (see BioCentury Extra, Tuesday, Jan. 15).

Value-based pricing (January 21, 2013)
The Health Committee of the U.K. Parliament report, which calls for the U.K.'s Department of Health to provide details by March on the country's new value-based pricing system (see BioCentury Extra, Wednesday, Jan. 16).

Product documentation (January 21, 2013)
— Remicade: EMA's CHMP revised EPAR updating SPC to include a warning against concomitant use of Remicade infliximab with other biological therapeutics to treat arthritis due a potential increased risk of infection; from Johnson & Johnson (NYSE:JNJ).
— Simponi: EMA's CHMP revised EPAR updating SPC to include a warning against concomitant use of Simponi golimumab with other biological therapeutics to treat arthritis due a potential increased risk of infection; from Johnson & Johnson (NYSE:JNJ).
— Synflorix: EMA's CHMP revised EPAR updating SPC to include a warning regarding psychogenic syncope associated with injections of Synflorix to prevent pneumococcal disease; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
— Torisel: EMA's CHMP revised EPAR updating SPC to include information on drug interactions with lenalidomide for cancer drug Torisel temsirolimus; from Pfizer Inc. (NYSE:PFE).

California biotech (January 14, 2013)
2013 California Biomedical Industry Report from BayBio, the California Healthcare Institute and PricewaterhouseCoopers.

Cancer (PDF files) (January 14, 2013)
EMA final guidelines and appendix covering the clinical development of cancer treatments (see BioCentury Extra, Friday, Jan. 11).

Drug-drug interactions (PDF file) (January 14, 2013)
EMA final guidelines on studying pharmacokinetic interactions between new medical products and marketed drugs.

FDA (January 14, 2013)
FDA list of sBLA approvals in 2012.

Health spending (PDF file) (January 14, 2013)
U.S. Centers for Medicare & Medicaid Services' Office of the Actuary report noting that the overall growth in national health spending remained low in 2011, which the agency said raises questions over whether U.S. healthcare spending will rebound over the next few years (see BioCentury Extra, Tuesday, Jan. 8).

Opioids (PDF files) (January 14, 2013)
— FDA draft guidance outlining requirements to support abuse-deterrent labeling for opioids (see BioCentury Extra, Wednesday, Jan. 9).
— Voluntary guidelines from Mayor Michael Bloomberg and other New York City officials that recommend emergency rooms of the city's public hospitals not prescribe long-acting opioid painkillers (see BioCentury Extra, Friday, Jan. 11).

U.K. (PDF file) (January 14, 2013)
— U.K.'s National Health Service Innovation Scorecard that said the use of some drugs recommended by NICE was lower than expected in 2010 and 2011.
— U.K.'s National Health Service data on the use of NICE-recommended drugs in 2010 and 2011.

Product documentation (PDF files) (January 14, 2013)
— Exogen: NICE guidance supporting the use of Exogen ultrasound bone healing system to treat long bone fractures that have failed to heal after nine months; from Smith & Nephew plc (LSE:SN; NYSE:SNN).
— Invokana: Briefing documents for the Jan. 10 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), which voted 10-5 to recommend approval of Invokana canagliflozin to treat diabetes; from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, Jan. 10).

Fiscal cliff (PDF file) (January 7, 2013)
Text of the American Taxpayer Relief Act of 2012 (H.R. 8), which was enacted to prevent the expiration of income tax cuts and to defer for two months the implementation of budget sequestration (see BioCentury Extra, Wednesday, Jan. 2).

Generics (January 7, 2013)
Text of amendments approved by an EU committee to a proposed Transparency Directive, which would require EU member states to make pricing and reimbursement decisions on generic medicines within 60 days of approval (see BioCentury Extra, Tuesday, Dec. 18, 2012).

India R&D (PDF file) (January 7, 2013)
India's 2013 policy for science, technology and innovation, which said doubling gross expenditure in R&D to 2% of the country's GDP is realizable if the private sector raises R&D investment to match that of the public sector (see BioCentury Extra, Friday, Jan. 4).

IMI (PDF file) (January 7, 2013)
Europe's Innovative Medicines Initiative's eighth call for proposals to fund public-private partnerships addressing three topics, including antimicrobial resistance (see BioCentury Extra, Tuesday, Dec. 18, 2012).

IPAB (PDF file) (January 7, 2013)
Text of rules package (H. Res. 5) passed by the U.S. House of Representatives, which includes a measure aiming to block the House from considering recommendations for Medicare cuts from the Independent Payment Advisory Board (IPAB) (see BioCentury Extra, Friday, Jan. 4).

Recalcitrant cancers (PDF file) (January 7, 2013)
Text of the National Defense Authorization Act, which includes provisions to create an initiative within NIH's National Cancer Institute (NCI) to guide research on recalcitrant cancers — those with five-year survival rates less than 50% (see BioCentury Extra, Thursday, Jan. 3).

SBIR (PDF files) (January 7, 2013)
— U.S. Small Business Association (SBA) final rule that will implement changes to the Small Business Innovation Research (SBIR) program, such as eligibility criteria that now includes companies that are majority-owned by multiple domestic VCs (see BioCentury Extra, Friday, Dec. 28, 2012).
— U.S. SBA policy directive published in August 2012 covering the limitations on SBIR funding for majority venture-backed companies (see BioCentury Extra, Friday, Dec. 28, 2012).

SMEs (PDF file) (January 7, 2013)
EMA overview of EU initiatives to assist small and medium-sized enterprises (SMEs) with financing.

Product documentation (PDF files) (January 7, 2013)
— Bretaris/Eklira Genuair: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary assessment report that said Bretaris/Eklira Genuair aclidinium bromide from Almirall S.A. (Madrid:ALM) has "no additional benefit" over Spiriva HandiHaler tiotropium from Boehringer Ingelheim GmbH for chronic obstructive pulmonary disease (COPD) (see BioCentury Extra, Wednesday, Jan. 2).
— Inlyta: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary assessment report that said Inlyta axitinib from Pfizer Inc. (NYSE:PFE) provides a "significant additional benefit" over Nexavar sorafenib from Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) and Bayer AG (Xetra:BAYN) to treat advanced renal cell carcinoma (RCC) in patients who have failed treatment with a cytokine (see BioCentury Extra, Wednesday, Jan. 2).
— Lucentis: NICE final appraisal determination (FAD) recommending Lucentis ranibizumab for diabetic macular edema (DME) in patients with central retinal thickness of at least 400 um; from Novartis AG (NYSE:NVS; SIX:NOVN) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).