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The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable. Read More
Australia’s Therapeutic Goods Administration (TGA) will aim to make a decision on an orphan drug designation request within 20 working days of receipt of the application. Read More
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