Compounding (PDF file)
Text of bill S. 959, which was introduced in the U.S. Senate and would make compounding manufacturers subject to stricter regulation by FDA (see BioCentury Extra, Wednesday, May 15).
Drug tracking (PDF files)
—Text of the Drug Supply Chain Security Act (H.R. 1919), which the U.S. House Energy and Commerce committee agreed by voice vote to send to the full U.S. House and would create an electronic national system for tracking and tracing pharmaceutical products (see BioCentury Extra, Wednesday, May 15).
— Text of an amendment to H.R. 1919, which the U.S. House of Representatives Energy and Commerce committee voted against and would have required the development and implementation of an electronic unit-level tracking system for drugs within 10 years (see BioCentury Extra, Wednesday, May 15).
Elan (PDF file)
Defense document from the board of Elan Corp. plc (NYSE:ELN) to its shareholders recommending that they reject a formal offer from Royalty Pharma to acquire the company (see BioCentury, May 20).
Electronic data (PDF file)
FDA final guidance on best practices for conducting and reporting on pharmacoepidemiologic safety studies that use electronic healthcare data.
FDA (PDF file)
Letter from the U.S. House of Representatives Energy and Commerce Committee to FDA Commissioner Margaret Hamburg seeking information about the departure of Leona Brenner-Gati as acting deputy commissioner for medical products and tobacco (see BioCentury Extra, Tuesday, May 14).
Legal analysis released by Sen. Tom Coburn (R-Okla.) indicating that if members of Congress fail to confirm members of the Independent Payment Advisory Board, HHS Secretary Kathleen Sebelius would be empowered to formulate and implement Medicare cuts (see BioCentury Extra, Friday, May 17).
JOBS (PDF file)
Text of H.R. 701, which was passed by the U.S. House of Representatives and gives the U.S. Securities and Exchange Commission an Oct. 31 deadline to complete rulemaking on reforms under the Jumpstart Our Business Startups (JOBS) Act to the Regulation A exemption (see BioCentury Extra, Thursday, May 16).
Medicare (PDF file)
HHS's Office of Inspector General (OIG) report estimating that Medicare would have saved $510 million in 2011 on erythropoietin stimulating agents (ESAs) Aranesp darbepoetin alfa and Epogen epoetin alfa from Amgen Inc. (NASDAQ:AMGN) if the bundled payment rate for end-stage renal disease (ESRD) patients had been adjusted to reflect the use of the anemia drugs (see BioCentury Extra, Monday, May 13).
Notice for NIH's National Center for Advancing Translational Sciences (NCATS) seeking input on its proposed plan to avoid the "potential duplication, redundancy and competition" of the center's efforts with industry activities; comments are due June 14 (see BioCentury Extra, Wednesday, May 15).
Patents (PDF file)
U.S. Supreme Court decision in Bowman v Monsanto ruling unanimously that Vernon Hugh Bowman infringed the patent rights of Monsanto Co. (NYSE:MON) when he grew soybeans that he had purchased from a grain elevator (see BioCentury Extra, Monday, May 13).
Stocks (PDF file)
Text of the Spread Pricing Liquidity Act, which was introduced in the U.S. House of Representatives and would allow companies with a market cap of less than $500 million and average daily trading volume under 500,000 shares to select to have their securities quoted at increments of either $0.05 or $0.10 while maintaining trading between the quoted ticks.
Transparency (PDF file)
Text of the Trial and Experimental Studies Transparency (TEST) Act, which was reintroduced in the U.S. House of Representatives and would impose stronger reporting requirements on clinicaltrials.gov.
— Adcetris: Germany's Federal Joint Committee (G-BA) final assessment concluding that Adcetris brentuximab vedotin has an "unquantifiable" degree of additional benefit to treat relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) and relapsed or refractory CD30-positive Hodgkin's lymphoma; from Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and (see BioCentury Extra, Thursday, May 16). (PDF file)
— Betmiga: The U.K.'s NICE final appraisal determination (FAD) recommending Betmiga mirabegron for the symptomatic treatment of overactive bladder (OAB) only in patients for whom antimuscarinic drugs are not suitable; from Astellas Pharma Inc. (Tokyo:4503). (PDF file)
— Menveo: EMA's CHMP revised EPAR updating SPC to include febrile convulsion and tonic convulsion as adverse reactions for Menveo to vaccinate people ages 2 years or older at risk of exposure to Neisseria meningitides groups A, C, W135 and Y; from Novartis AG (NYSE:NVS; SIX:NOVN).
— Pixuvri: Germany's Federal Joint Committee (G-BA) final benefit assessment concluding that Pixuvri pixantrone provides "no additional benefit" over patient-individualized care 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, May 17). (PDF file)
— Trajenta: Germany's Federal Joint Committee (G-BA) final benefit assessment concluding that Trajenta linagliptin as add-on therapy to insulin with or without metformin to treat Type II diabetes provides "no additional benefit" over human insulin and metformin; from Boehringer Ingelheim GmbH (see BioCentury Extra, Friday, May 17). (PDF file)