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- Read more about NATCO receives generic Ledipasvir Sofosbuvir approval for India
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.
- Read more about Matinas BioPharma’s Lead Antibacterial Development Candidate MAT2501 Granted QIDP Designation by U.S. FDA
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.
- Read more about Antares Pharma Announces FDA Approval of Sumatriptan Injection USP
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.
- Read more about In Pursuit of AIDS Vaccine TSRI Scientists Shed Light on Antibody Origins
LA JOLLA, CA From Peter Parker’s fateful spider bite to Arthur pulling the sword from the stone at the beginning of his reign—everyone likes to know a hero’s origin story.
- Read more about Amgen reacquired three brands from GSK in 48 Countries
Amgen has entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia® (denosumab), XGEVA® (denosumab) and Vectibix® (panitumumab) in 48 countries in Asia, South America, Europe, Australia and other regions throughout the world. The agreement involves key expansion markets for Amgen including Brazil, China, Colombia, Hong Kong, Israel, Singapore, South Korea, Taiwan and Thailand.
- Read more about Merck Statement on FDA Advisory Committee Meeting on IMPROVE-IT Study with VYTORIN
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.
- Read more about AstraZeneca to harness power of the Secretome and develop next-generation biologics in collaboration with new Wallenberg Centre for Protein Research
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.
- Read more about AcelRx Pharmaceuticals conducts Pre-NDA Meeting with USFDA for ARX-04
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).
- Read more about UBM India Pharma Awards received by top Pharma companies
The UBM India Pharma Awards 2015 held on 30th November, 2015 in, Mumbai, celebrated excellence and recognized contribution of Indian Pharmaceutical Companies. The 3^rd Edition of Annual India Pharma Awards in association with TAKE solutions provided an opportunity for the companies to showcase their innovations and accomplishments in the sector.
- Read more about FDA approves first emergency treatment for overdose of certain types of chemotherapy
The U.S. Food and Drug Administration approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.