Pharma News

Takeda Pharmaceutical Company Limited announced that they have entered into a definitive agreement under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or an enterprise value of approximately $5.2 billion. The transaction has been approved unanimously by the boards of directors of both companies, and is expected to close by the end of February 2017, subject to required regulatory approvals and other customary closing conditions. Sarissa Capital, the holder of 6.6% of ARIAD’s common shares, as well as each of the members of ARIAD’s Board of Directors have agreed to tender their shares to Takeda pursuant to the offer

Prima BioMed Ltd, a leading immuno-oncology company, announced that it has entered into a new collaboration agreement with Japan’s CYTLIMIC, a recent spin off from NEC Corporation (NEC), to test a cancer peptide vaccine in combination with IMP321.
Under the new Material Transfer Agreement (MTA) Prima will provide IMP321 for a formulation development targeting a new pre-clinical and clinical development study to be conducted by CYTLIMIC. The development will be funded by CYTLIMIC and the MTA will be revenue generating for Prima

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.

The Medical Technology Association of India (MTaI) has been proactively and collaboratively working with the authorities in the process on pricing discussions over the past many months. We are committed to have a fair and transparent mechanism of pricing which accounts for the innovative nature of the sector.