Industry News

Allergan plc. announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.

Zambon S.p.A., an international pharmaceutical company committed to the CNS therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (Newron), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the CNS and pain, announced the availability of Xadago (safinamide) in the United Kingdom.

In roughly one-third of pancreatic cancer patients, tumors have grown around the pancreas to encompass critical blood vessels. Conventional wisdom has long held that surgery to remove the tumors is rarely an option, and life expectancies are usually measured in months. Mayo Clinic, teaming oncologists, gastrointestinal and vascular surgeons and others, is finding that many of these patients actually are candidates for surgery. Mayo has been fine-tuning a protocol to treat them, and in two studies, found survival now stretching into years.

Allergan plc  announced that the Japanese Ministry of Health, Labour and Welfare has approved an additional use for BOTOX Vista® (Allergan's botulinum toxin type A product) as a treatment for crow's feet lines (CFL).

Avantis Medical Systems, Inc announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Third Eye® Panoramic™ device for use as a resposable product for colonoscopies.  Previously cleared as a disposable device, this latest clearance now allows Third Eye Panoramic to be marketed in the U.S. as a resposable device that can be used multiple times prior to disposal.

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Egalet Corporation announced that it has reached an agreement with Purdue Pharma L.P. as it relates to alleged patent infringements against Egalet and product licensor Acura Pharmaceuticals, Inc. for OXAYDO® (oxycodone HCl, USP) tablets CII.

Zealand announces that the US Food and Drug Administration (FDA)  has made briefing documents on lixisenatide and the lixisenatide/Lantus® combination available on its website. The documents relate to the upcoming meeting of the Endocrinologic and Metabolic Drugs Advisory Committee, scheduled by the FDA for 8:00 am to 5:00 pm ET on 25 May 2016 to discuss the New Drug Applications (NDAs) for the two drug products intended for the treatment of adults with Type 2 diabetes. The NDAs were submitted by Sanofi.

Astellas Pharma Inc., Daiichi Sankyo Company, Limited and Takeda Pharmaceutical Company Limited announced that they have entered into a joint research agreement. It is an agreement to comprehensively acquire and analyze fundamental biomarker data on healthy adult volunteers in order to optimize and accelerate the development of innovative medicines.

Horizon Pharma plc (Horizon Pharma), a biopharmaceutical company, announced that its affiliate has entered into a definitive agreement with Boehringer Ingelheim International GmbH (Boehringer Ingelheim) to acquire the rights to interferon gamma-1b, which Boehringer Ingelheim commercializes under the trade names Imukin, Imukine, Immukin and Immukine in an estimated 30 countries primarily in Europe and the Middle East.

Merck,  known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.