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GPhA is putting forward a compromise naming scheme for biosimilars that it hopes will quell the dispute over how to assign international nonproprietary names (INN) to follow-on biologics. Read More
Pfizer was dealt a heavy blow Wednesday after a judge cleared the way for five generic drugmakers to begin making generic versions of Pfizer’s blockbuster osteoarthritis drug Celebrex. Read More
The FDA has slapped Institut Biochimique SA (IBSA) and Akirmax Pharmaceuticals with an untitled letter for omitting risk information and important contraindications on a Facebook page promoting the hyperthyroid drug Tirosint. Read More
Bayer and Onyx’s drug Nexavar joins a growing list of drug candidates targeting liver cancer that have failed in Phase III. The drugmakers revealed Tuesday the product did not meet its primary endpoint. Read More
The partnership will bring together researchers to discover and develop new drugs for autoimmune diseases currently treated with small-molecule biologics. Read More
Drugmakers in the EU are pushing back against a proposal moving through the EU Parliament that would grant clinical trial participants the right to demand that their trial data — including data shared between regulators and other entities — be deleted. Read More
Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Both recalls were included in the FDA’s March 5 enforcement report. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More
Compounding pharmacies have flooded the FDA with hundreds of comments seeking to protect access to bulk drug substances they use to make products. Read More