Drugs in the Pipeline
Baxter announced that it has submitted a biologics license application (BLA) to the Food and Drug Administration (FDA) for BAX111, the first recombinant von Willebrand Factor (rVWF) for patients with von Willebrand disease.
Eiger BioPharmaceuticals announced that the Food and Drug Administration (FDA) has granted lonafarnib an Orphan Designation for the treatment of hepatitis delta virus (HDV) infection.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Translarna (ataluren) for the treatment of patients with Mucopolysaccharidosis I (MPS I).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to ADI-PEG 20 (pegylated arginine deiminase; Polaris) for the treatment of malignant pleural mesothelioma (MPM).
Tetraphase Pharmaceuticals announced positive results from Phase 3 IGNITE 1 trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem.
Pfizer announced top-line results from a Phase 3 study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (PHN).
The Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Yosprala (aspirin and omeprazole delayed-release tablets) 81/40 and 325/40.
Bayer Healthcare has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.
CSL Behring announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for rIX-FP (Coagulation Factor IX [Recombinant], Albumin Fusion Protein), its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin for patients with hemophilia B.
Genentech has submitted a New Drug Application (NDA) to the FDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.
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