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By a two to one vote, a Federal Circuit Court of Appeals panel cleared the way for Sandoz’s launch of Zarxio, the first FDA-approved biosimilar, as early as today. Read More
Requiring drug compounders to provide information on all products taken by a patient that may be “suspect” in an adverse reaction would be unduly burdensome, necessitating full access to a patient’s medical records, the International Academy of Compounding Pharmacists says. Read More
A flu vaccine manufacturing site that was recently transferred from Novartis to CSL Limited received an FDA Form 483 for problems with cleaning equipment, stability studies, batch certification and other issues. Read More
Valeant Pharmaceuticals will pay up to $445 million for the rights to AstraZeneca’s investigational psoriasis drug brodalumab, which is set for regulatory submissions in the U.S. and EU in the fourth quarter. Read More
EU biopharma groups have lodged a complaint with the European Commission opposing a French law that promotes off-label use of medicines, saying it put cost ahead of patient safety. Read More
The FDA has granted priority review for Bristol-Myers Squibb and AbbVie’s Empliciti for the treatment of multiple myeloma in patients who have received one or more previous therapies — giving it a PDUFA date of Feb. 29, 2016. Read More
The European Medicines Agency’s medical literature monitoring service kicked into full operation Tuesday, allowing drugmakers to easily search for information on adverse reactions associated with their products. Read More
Eli Lilly continued to beat back court challenges against Cymbalta, as a Virginia jury on Tuesday found the drugmaker not negligent in marketing its blockbuster antidepressant. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released Sunday. Read More