BLA news from FierceBiotech
NewsIpsen 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... Read more...
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... Read more...
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... Read more...
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... Read more...
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... Read more...
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,... Read more...
Press Release: Dendreon Corporation's PROVENGE Granted FDA Priority ReviewPress Release: Dendreon Corporation's PROVENGE Granted FDA Priority Review ... Read more...Press Release: Auxilium Pharmaceuticals Amends Agreement with Cobra BiologicsPress Release: Auxilium Pharmaceuticals Amends Agreement with Cobra Biologics ... Read more...Acambis shares plunge after U.S. nixes contractShares of Acambis took a beating after the company announced it was no longer in the competition for a U.S. contract to provide smallpox vaccine. Its stock plunged 39 percent after company officials said it was no longer being considered. Acambis said that it would arrange a meeting with government officials to "seek clarification." "We are surprised that the U.S. government would eliminate Acambis," CEO Gordon Cameron said. "We believe that our proposal would have met the … ... Read more... | Press ReleasesFDA Accepts ATryn® BLA FilingFDA Accepts ATryn® BLA Filing GTC Receives $2 Million in Milestone Payments October 6, 2008 FRAMINGHAM, Mass.--(BUSINESS WIRE)--The US Food and Drug Administration, or FDA, has accepted for Read more >> Ipsen: FDA's First-Cycle Review of Dysport® to Be Completed by Year-EndIpsen: FDA's First-Cycle Review of Dysport® to Be Completed by Year-End US launch of Dysport® on track PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Paris:IPN) today announced that the U.S. Read more >> Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary AngioedemaDyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX) announced today the completion of its Read more >> Introgen Receives Notice ADVEXIN® U.S. BLA Not Sufficiently Complete to FileIntrogen Receives Notice ADVEXIN® U.S. BLA Not Sufficiently Complete to File Introgen Intends to Appeal FDA Decision AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN), a Read more >> |
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