FDA accepts Pfizer application for genetic disease drug
NEW YORK — The Food and Drug Administration will review a regulatory approval application from Pfizer for a drug to treat an extremely rare and fatal degenerative disease, Pfizer said Wednesday.
Pfizer announced that the FDA had accepted its application for tafamidis meglumine, a treatment for transthyretin familial amyloid polyneuropathy. The disease, also known as TTR-FAP, is a fatal genetic illness that affects about 8,000 people worldwide and causes severe sensory loss, pain, weakness and organ dysfunction.
The FDA expected to reach a decision on the drug by June. The European Commission approved the drug in November 2011 under the brand name Vyndaqel.
Mylan rebrands Dey Pharma unit
PITTSBURGH — Mylan is changing the name of its branded specialty pharmaceutical business, the company said Wednesday.
The drug maker announced that it would change the name of Dey Pharma to Mylan Specialty. Dey makes treatments for respiratory diseases, psychiatric disorders and severe allergic reactions, including the EpiPen (epinephrine).
The rebranding of the subsidiary comes just months after a similar change to the name of another subsidiary, Matrix Labs, whose name the company changed to Mylan Labs in 2006. Mylan acquired Hyderabad, India-based Matrix in 2006.
Biogen Idec to acquire Stromedix
CAMBRIDGE, Mass. — Drug maker Biogen Idec plans to spend up to more than $560 million to buy a company developing treatments for organ failure.
Biogen Idec announced that it would pay $75 million upfront, plus up to $487.5 million in milestone payments to acquire privately-owned biotech company Stromedix. Stromedix’s lead drug candidate is STX-100, a monoclonal antibody entering phase-2 trials as a potential treatment for idiopathic pulmonary fibrosis, a disease that causes difficulty breathing due to scarring of the lungs and is almost always fatal.
"Fibrotic organ failure, and in particular IPF, is a terrible disease with a high mortality rate, and there are no effective treatments at this time," Biogen Idec EVP research and development Douglas Williams said. "We believe STX-100 has the potential to be a best-in-class therapy, and it is an excellent strategic fit with our focus on highly differentiated programs with the potential to make a real difference for patients."