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Fdanewsdrugdailybulletin

Oct. 29, 2012

Vol. 9 No. 212

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Senate HELP Committee Confronts State Board Over NECC Pharmacy Classification

The Senate Committee on Health, Education, Labor, & Pensions (HELP) is launching a probe of the compounding crisis, asking the Massachusetts pharmacy registrar to explain why New England Compounding Center (NECC) was allowed to operate as a large-scale drug manufacturer. Read More

China Cuts Cancer Drug Prices

China’s National Development and Reform Commission reduced the prices of 95 anti-tumor drugs by an average of 17 percent. Read More

GSK Plans to Open Patient-Level Trial Data to Outside Researchers

GlaxoSmithKline will soon give researchers access to detailed anonymized patient-level clinical data for approved drugs and dropped investigational products. Read More

FDA: Don’t Tighten Vicodin Regulation

Hydrocodone-containing combination products, such as hydrocodone/acetaminophen (Vicodin), should be kept as Schedule III controlled substances and not be subject to tighter regulations to prevent abuse, the FDA said. Read More

Mylan CEO Eyes Acquisitions Valued at More than $4 Billion

Generic-drug maker Mylan is on the prowl for acquisitions to bolster its product line and expand geographically, and would consider deals valued at “well over” $4 billion, the company’s leader said Thursday. Read More

Drugmaker Boehringer Settles Marketing Claim for $95 Million: U.S.

Boehringer Ingelheim Pharmaceuticals Inc agreed to pay $95 million to U.S. government agencies to settle civil allegations that it illegally marketed drugs for unapproved uses, the U.S. Justice Department said. Read More

Wilex Rencarex Phase III Result Shows No Efficacy

Redectane and Mesupron are now Wilex’s key products after the Rencarex Phase III ARISER data showed no efficacy; Rencarex has been discontinued. Read More

Novartis Cannibalizes Gleevec to Boost New Cancer Drug

Novartis AG wants patients to stop taking one of its best-selling drugs. Read More

Price Swings Hit Generic Drugs, Shortage of Manufacturers Blamed

Generic drugs often save you a lot of money over name-brand pharmaceuticals. Read More