Industry News

LabStyle Innovations Corp., developer of the Dario Diabetes Management Solution, announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the Apple iOS 6.1 platform and higher.

Eagle Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Docetaxel injection, non-alcohol formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel injection in the US.

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. ARX-04 (sufentanil sublingual tablet, 30 mcg) is being developed for the treatment of moderate-to-severe acute pain in adult patients administered by a healthcare professional in a medically supervised setting.

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 Famotidine Tablets USP, 20 mg and 40 mg.

Celgene Corporation announced the settlement of litigation with Natco Pharma Ltd. of India, Natco's U.S. partner, Arrow International Limited, and Arrow's parent company, Watson Laboratories, Inc. (a wholly-owned subsidiary of Allergan plc) relating to patents for REVLIMID® (lenalidomide).

Merck, known as MSD outside the United States and Canada, announced that the application for Emergency Use Assessment and Listing (EUAL) for the company’s investigational Ebola Zaire vaccine, V920 (rVSV?G-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization (WHO).

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation announced that REVLIMID® (lenalidomide), a cancer medicine that is administered orally, has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for use in combination with dexamethasone as a treatment for patients newly diagnosed with multiple myeloma. This marketing authorization expands upon the approval of REVLIMID in 2010 for the treatment of patients with relapsed or refractory multiple myeloma.

Recipharm AB, a leading contract development and manufacturing organisation in the pharmaceutical industry, has entered into the previously announced strategic collaboration with Alcon, a Novartis company, and signed a long term supply agreement whereby Recipharm will manufacture a range of ophthalmic products using Blow Fill Seal technology.

Sanofi Pasteur, the vaccines division of Sanofi, announced  that the Philippines have granted marketing approval to Dengvaxia®, making it the first vaccine to be licensed for the prevention of dengue in Asia.