Pharma News

Lipocine Inc.  announced receipt of additional guidance from the U.S. Food and Drug Administration ("FDA") on the LPCN 1107 pivotal Phase 3 clinical study design.  LPCN 1107, a novel oral hydroxyprogesterone caproate ("HPC") product candidate that has been granted orphan drug designation by the FDA, is in development for the proposed indication of reducing the risk of preterm birth ("PTB") in women with singleton pregnancy who have a history of singleton spontaneous PTB. Prevention of PTB is a significant unmet need as ~11.7% of all U.S. pregnancies result in PTB (delivery less than 37 weeks), a leading cause of neonatal mortality and morbidity

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Egalet Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ARYMO™ ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Ajanta Pharma Limited, a specialty pharmaceutical formulation company, has received US FDA final approval for duloxetine hydrochloride delayed release capsules.

AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, has recently announced that the US Food and Drug Administration (FDA) has conditionally accepted the brand name, Dsuvia (sufentanil sublingual tablet, 30 mcg), for the company's investigational product candidate, ARX-04. In addition, AcelRx has applied to the US Patent and Trademark Office to obtain federal registration of the Dsuvia mark.

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).