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PhRMA has asked the Office of the U.S. Trade Representative to put the EU on notice for its plan to publish clinical trial data that currently is treated confidentially. Read More
The UK’s Medicines and Healthcare products Regulatory Agency recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 — the majority coming from companies complaining about their competitors. Read More
Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More
The UK’s healthcare costs watchdog has once more rejected Celgene’s blockbuster cancer drug Revlimid for a new indication. This time, the National Institute for Health and Care Excellence (NICE) says the drug failed to show clear efficacy and cost-effectiveness as a second-line treatment for multiple myeloma. Read More
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