Latest Headlines

Latest Headlines

Dendreon files BLA for Provenge

Seattle-based Dendreon (DNDN) has filed for FDA approval of the prostate cancer drug Provenge, taking another big step as it builds the framework for a national distribution system for the new

Auxilium's xiaflex BLA granted priority review

PA-based Auxilium Pharmaceuticals announced today that the FDA has accepted its biologics license application for Xiaflex and granted the submission priority review. Xiaflex is a first-in-class

FDA accepts Barr BLA for first biologics

Barr Pharmaceuticals announced Thursday that the FDA has accepted their application for the company's first two biologics, developed for the Department of Defense. The vaccine pills are designed to

Ipsen inks a string of deals in expansion effort

France's Ipsen is buying out Tercica in a $404 million deal, one of three new pacts designed to

Acambis lands $425M smallpox vaccine contract

The U.K.'s Acambis has won a $425 million contract to supply the CDC with its smallpox vaccine for 10 years. Acambis will establish a U.S.-based manufacturing capability for ACAM2000 and deliver a

Genzyme gets biosimilar rejection, builds R&D plant

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug

ALSO NOTED: Ipsen files new BLA;Amgen selects Vectibix test; and much more...

> Ipsen says it has submitted a new BLA for Reloxin, addressing concerns raised by the FDA when the agency declined to file its BLA in January.

Experts to weigh in on Amgen's Nplate

Amgen is going before the FDA's Oncologic Drugs Advisory Committee (ODAC) in order to discuss its BLA for Nplate (romiplostim). The drug is a treatment for thrombocytopenia, a disorder that causes

Medicis shares sink as FDA rejects BLA

Medicis Pharmaceutical earned an "incomplete" grade on its latest BLA. The FDA has refused to accept the application for Reloxin--botulinum toxin type A--for a variety of shortfalls, including a gap

Emerging Drug Developer: Tolerx

Emerging Drug Developer: Tolerx Holding promising Phase II data for a monoclonal antibody lined up for a late-stage race to the FDA,