Industry News

Otonomy, Inc., a biopharmaceutical company, announced positive results from its pivotal phase 3 clinical trial of Otiprio (ciprofloxacin otic suspension) in patients with acute otitis externa (AOE), also known as swimmer's ear.

Mast Therapeutics, Inc.,a publicly traded biopharmaceutical company, and Savara Inc. (Savara), a privately-held emerging specialty pharmaceutical company, announced that the two companies have entered into a definitive merger agreement, under which the stockholders of Savara would become the majority owners of Mast, and the operations of Mast and Savara would be combined.  Subject to stockholder approval, the combined company will advance a pipeline of novel inhalation therapies for the treatment of diseases with significant unmet medical needs, featuring three product candidates, each in advanced clinical development.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL (5 mg/mL), 1000 mg/100 mL (10 mg/mL), and 1500 mg/100 mL (15 mg/mL) (Single-use bags).

Sobi Canada Inc., a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi), announced that Health Canada has approved Orfadin (nitisinone) capsules for the treatment of hereditary tyrosinaemia type-1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver, brain and kidney complications and can be fatal if untreated.

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Senhwa Biosciences, Inc. announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to CX-4945 for the treatment of cholangiocarcinoma.

Alexion Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a debilitating, ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in hemolysis (destruction of a patient’s red blood cells).

Adamas Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. The ADS-5102 application has been given a Prescription Drug User Fee Act (PDUFA) target action date of August 24, 2017.

Sun Pharma announced successful phase 3 confirmatory clinical trial results for Seciera (cyclosporine A, 0.09% ophthalmic solution), for the treatment of dry eye disease. Seciera is a patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09%. It is a clear, preservative-free, aqueous solution. Seciera is being developed by Ocular Technologies, a company recently acquired by Sun Pharma. Following this acquisition, Sun Pharma owns exclusive, worldwide rights to Seciera and is developing it to commercialize for global markets including US, Europe, and Japan, as well as several emerging markets.

KaloBios Pharmaceuticals, Inc. announced positive guidance in the minutes from a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the development plans for benznidazole for the treatment of Chagas disease, a neglected tropical disease.

Elanco US Inc., a subsidiary of Eli Lilly and Company, has completed the acquisition of Boehringer Ingelheim Vetmedica, Inc's (BIVI) US feline, canine and rabies vaccines portfolio - as well as a fully integrated manufacturing and R&D site and several pipeline assets.