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Astellas Pharma and Medivation won a new indication for their joint cancer therapy Xtandi, allowing the drug to be given to a wider swath of men with metastatic castration-resistant prostate cancer. Read More
A federal judge has denied a motion by Merck to dismiss two lawsuits involving its mumps vaccine, one by whistleblowers alleging the company presented misleading efficacy data on the vaccine, and another by direct purchasers who contend the company created a monopoly on the product. Read More
Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line. Read More
Draft FDA guidance on how drugmakers can use social media and web-based forums threatens to prevent the industry from interacting with customers online for fear that companies will be responsible for continuously monitoring any discussions they participate in, drugmakers say. Read More
The FDA said yesterday that Justice Department official Cynthia Schnedar will become director of CDER’s Office of Compliance starting Oct. 6. Read More
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