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The UK’s cost-effectiveness watchdog is recommending against coverage of Celgene’s cancer drug Ambraxane with gemcitabine for patients with previously untreated metastatic pancreatic cancer, citing its expensive price and limited benefits compared with current treatments. Read More
The Federal Trade Commission is suing AbbVie and its partner Besins Healthcare, along with generic firm Teva, over an alleged pay-for-delay deal that put off generic entry of AbbVie and Besins’s blockbuster testosterone gel AndroGel 1%. Read More
FDA officials sought to clarify how the agency’s authority to punish drugmakers for obstructing facility inspections applies to such issues as divulging trade secrets, accessing emails and translating documents into English. Read More
Australia’s pharmaceutical regulatory body has adopted European guidance on good pharmacovigilance practices for vaccines, including the reporting of reduced effectiveness or vaccine failure, and implementing a recall or halting distribution of batches. Read More
The European Commission has approved a new indication for Roche’s rheumatoid arthritis drug RoActemra to treat patients in the early phase of the disease. Read More
Connecticut’s Attorney General has joined a growing chorus of voices urging the FDA to immediately approve a generic version of AstraZeneca’s acid-reflux drug Nexium, either by clearing first-filer Ranbaxy’s version or by finding that the Indian firm forfeited its exclusivity because of rampant delays. Read More
The head of a non-profit that pushes for more products to be made in the U.S. is suing Apotex and Costco for selling a generic of the cholesterol drug Lipitor that didn’t indicate it was made in India. Read More
New Jersey-based compounder Pharmacy Creations is recalling one lot each of four products after a former testing laboratory found that the lots in question may not be sterile. Read More
A federal judge last week affirmed the FDA’s decision to approve generic versions of Hospira’s sedative Precedex under a pathway that allows manufacturers Mylan and Par to proceed with generics that “carve out” the brand firm’s method-of-use patent in the drug’s labeling. Read More