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- Read more about US FDA grants marketing approval to Varian Medical's Nexus DR digital X-Ray imaging system
Varian Medical Systems announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Nexus DR, a high resolution imaging system for X-ray imaging using a digital X-ray detector. The Nexus DR is designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications. The system is a single common imaging platform intended for general radiographic procedures (excluding fluoroscopy, angiography, and mammography).
- Read more about US FDA approves Aralez's aspirin & omeprazole FDC
Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved once-daily Yosprala, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the US. Yosprala is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The company is expanding its US sales force by 85 representatives in September to a total of 110 high quality sales representatives and plans to begin the US promotional launch of Yosprala the first week in October.
- Read more about Sanofi Files Suit in U.S. to Defend Patent Rights on Lantus® and Lantus® Solostar®
Sanofi announced that it filed a patent infringement suit against Merck Sharp & Dohme Corp. (“Merck”) on September 16, 2016 in the United States District Court for the District of Delaware. In its suit Sanofi alleges infringement of ten patents.
- Read more about FDA Conditional Acceptance Neuroscience Proprietary Name INGREZZA™ for VMAT2 Inhibitor Valbenazine
Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name "INGREZZA™" for the Company's once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine.
- Read more about Teva Launch Authorized Generic of Cubicin in the United States
Teva Pharmaceutical Industries Ltd., announced the launch of an authorized generic of Cubicin® (daptomycin for injection) 500 mg per vial in the United States.
- Read more about Novavax present Topline RSV F Vaccine Data from Two Clinical Trials in Older Adults
Novavax, Inc., announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve™ trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.

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- Read more about Dr Reddy’s expand its strategic collaboration with Amgen in India
Dr Reddy’s Laboratories Ltd recently announced that it has expanded its strategic collaboration with Amgen, one of the world's leading independent biotechnology companies, to market and distribute three of Amgen’s medicines in India in the therapy areas of oncology and osteoporosis. Under the terms of the collaboration, Dr Reddy’s will commercialise XGEVA (denosumab), Vectibix (panitumumab) and Prolia (denosumab) in India.
- Read more about AstraZeneca present two new phase IIIb trials for Forxiga
AstraZeneca announced two new randomised, placebo-controlled Phase IIIb outcome trials with Forxiga (dapagliflozin), an SGLT-2 inhibitor currently indicated for the treatment of type-2 diabetes. These two large outcome trials will help to define the potential role of dapagliflozin in the management of chronic kidney disease and chronic heart failure respectively, in people with and without type-2 diabetes.
- Read more about Array BioPharma Announces Phase 3 BEACON CRC SPA Agreement with FDA
Array BioPharma announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.
- Read more about Fluxion Biosciences launch IsoFlux Cytation Imager for automated CTC analysis
Fluxion Biosciences, Inc. announced that it has launched a new imaging system, the IsoFlux Cytation Imager, designed to work exclusively with the IsoFlux Liquid Biopsy System and CTC Enumeration Kit. The IsoFlux Cytation Imager comes pre-configured with all components and software required for automated CTC image acquisition.