Industry News

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced a collaboration agreement with Teva Pharmaceutical Industries Ltd. ("Teva"), a leading global pharmaceutical company. With this agreement, Egalet granted Teva exclusive marketing and commercialization rights to SPRIX (ketorolac tromethamine) Nasal Spray in Israel, Gaza and the West Bank. Teva, a leader in the commercialization of central nervous system (CNS) products, including many in pain management, will be responsible for registering, marketing, distributing and selling SPRIX Nasal Spray in these territories. Under the terms of the agreement, Egalet will receive an undisclosed upfront payment, sales-based milestones and will share in the profits from net sales of SPRIX in these territories. 

Natco Pharma Limited  announced that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.

Matinas BioPharma Holding Inc., a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective therapeutics for the treatment of serious and life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibacterial development candidate, MAT2501, as a Qualified Infectious Disease Product (QIDP) for the treatment of non-tuberculous mycobacterium (NTM) infections.

Antares Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established. The reference listed drug in the ANDA was GlaxoSmithKline’s Imitrex® Injection. Sumatriptan Injection USP represents the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX® auto injector platform. In accordance with our previously disclosed agreement, Teva Pharmaceutical Industries, Ltd. (Teva) will distribute the product through their U.S. generic division and share the profits equally with Antares Pharma.

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Merck , known as MSD outside the United States and Canada, issued  the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss the results of IMPROVE-IT, an investigational study comparing treatment with VYTORIN® (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes.

AstraZeneca and its global biologics research and development arm, MedImmune,  announced a three-year collaboration with the newly established Wallenberg Centre for Protein Research (WCPR). The collaboration aims to develop new technologies for biologics production and to identify new targets for disease research in the ground-breaking area of the Secretome - research into all proteins that are secreted by a cell or that are exposed to the outside of the cell from within the cell membrane.

AcelRx Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, reported on the outcome of the ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA).