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Generic drugs continued their market growth last year, rising two percentage points to 86 percent of all prescriptions dispensed in the U.S. market, according to a new study. Read More
An FDA advisory panel is recommending against approval of Actavis’ NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA has cleared Takeda and Orexigen Therapeutics’ weight-loss drug Contrave, the first new anti-obesity product to win approval in more than two years. Read More
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 UK’s cost-effectiveness agency plans to seek access to clinical trial data from European regulators if drug companies fail to supply relevant information, according to an updated process guide for developing technology appraisal recommendations.
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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
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