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Emergent BioSolutions has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military. Read More
The FDA has approved GlaxoSmithKline and Genmab’s Arzerra and Leukeran as a first-line combination treatment for the most common form of blood and bone marrow cancer. Read More
Opko Health said Thursday it has signed a definitive agreement to acquire Israeli-based Inspiro Medical, giving the drugmaker a delivery vehicle for its respiratory therapies. Read More
A UK coalition of drugmakers and a cancer research group are launching an analysis of failed Phase III lung cancer drug trials that will search for treatments that, despite failing overall, are effective for certain subpopulations. Read More
U.S. and EU regulators have both determined that Boehringer Ingelheim’s volasertib for acute myeloid leukemia is an orphan drug, the German drugmaker said Thursday. Read More
Baxter said Wednesday that its Bax 111 treatment for Von Willebrand disease met its primary endpoint in a pivotal clinical trial, setting it up for NDA filing later this year. Read More
The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More