Corruption (PDF file)
Indian parliamentary report that found sufficient evidence of a "collusive nexus" between the country's drug regulator and pharmaceutical companies to expedite approval of drugs (see BioCentury Extra, Thursday, May 10).

Medicare
CMS's Medicare Evidence Development & Coverage Advisory Committee agenda for a May 16 meeting to review the characteristics of evidence required for the agency's Coverage with Evidence Development (CED) designation (see BioCentury Extra, Thursday, May 10).

NICE
U.K.'s NICE report from an advisory panel recommending an increase in the value attached to a drug's long-term benefit when calculating cost-effectiveness estimates per quality-adjusted year (QALY) (see BioCentury Extra, Friday, May 11).

Obesity (PDF file)
Briefing documents for the May 10-11 meeting of FDA's Gastroenterology and Urology Devices Panel to discuss issues in the development of weight loss devices placed endoscopically or laparoscopically (see BioCentury Extra, Tuesday, May 8).

PDUFA (PDF file)
U.S. House Energy and Commerce Committee new draft PDUFA reauthorization bill that is more closely aligned with the Senate PDUFA bill than previous versions (see BioCentury Extra, Monday, May 7).

Psoriasis (PDF file)
NICE draft clinical guideline on managing psoriasis.

Respiratory diseases (PDF file)
NHS companion document to its outcome strategy for chronic obstructive pulmonary disease (COPD) and asthma.

Product documentation
— Botox: NICE final appraisal determination (FAD) recommending the use of Botox onabotulinumtoxinA to prevent chronic migraines in patients who have not responded to at least three preventative medications and whose headaches are not caused by medication overuse; from Allergan Inc. (NYSE:AGN) (see BioCentury Extra, Thursday, May 10). (PDF file)
— Halaven: CHMP revised EPAR updating SPC to include pancreatitis as an undesirable effect for Halaven eribulin mesylate to treat locally advanced metastatic breast cancer in patients who have progressed after two or more chemotherapy regimens; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).
— Jevtana: NICE final guidance recommending against the use of Jevtana cabazitaxel as a second-line treatment for prostate cancer in combination with prednisone or prednisolone; from Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Thursday, May 10). (PDF file)
— Lorcaserin: Briefing documents for the May 10 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 18-7, with one abstention, that the benefit-risk profile for lorcaserin supports approval to treat obesity; from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) (see BioCentury, May 14).
— Tarceva: NICE draft guidance recommending the use of Tarceva erlotinib as first-line treatment for locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC), from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, May 9). (PDF file)
— Tofacitinib: Briefing documents for the May 9 meeting of FDA's Arthritis Advisory Committee, which voted 8-2 in favor of recommending approval of tofacitinib to treat moderately to severely active rheumatoid arthritis (RA) in patients who had inadequate response to one or more DMARDs; from Pfizer Inc. (NYSE:PFE) (see BioCentury, May 14).
— Truvada: Briefing documents for the May 10 meeting of FDA's Antiviral Drugs Advisory Committee, which concluded the benefit-risk profile for Truvada emtricitabine/tenofovir supports the drug's use as pre-exposure prophylaxis to reduce risk of HIV-1 infection in uninfected adults; from Gilead Sciences Inc. (NASDAQ:GILD) (see BioCentury, May 14).