Skip to main content

Business Wire

academics

 

Clinical research courses

  • Ferring Pharmaceuticals and Enteris BioPharma, Inc. announced that the companies have entered into a license agreement and initiated an early development agreement to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence™, to engineer an oral formulation of a peptide-based injectable therapeutic developed by Ferring.

  • U.S. District Court of Delaware ruling invalidating all asserted claims of the ‘250, ‘413, ‘776 and ‘302 patents for COPAXONE® (glatiramer acetate injection) 40 mg/mL by TEVA. The patent infringement case involved five of six Abbreviated New Drug Application (ANDA) filers. Teva plans to appeal the decision.

  • The Medical Technology Association of India (MTaI) has been proactively and collaboratively working with the authorities in the process on pricing discussions over the past many months. We are committed to have a fair and transparent mechanism of pricing which accounts for the innovative nature of the sector.

  • On average, an individual having three square meals a day consumes up to 148 grams of sugar. Today, sugar is a pervasive element of our diet in spite of it being linked to various heart diseases as well as an increased risk of diabetes. The World Health Organization recommends cutting down on sugars to not more than 5% of total  daily calorie consumption, or a few teaspoons in contrast to the excessive amounts the average individual tends to consume on a daily basis.

  • Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

  • Vedanta Biosciences, pioneering the development of a novel class of therapies for immune and infectious diseases based on rationally designed consortia of bacteria derived from the human microbiome, announced that the European Patent Office (EPO) has issued European Patent EP2575835. The patent broadly covers pharmaceutical compositions of Clostridium live bacterial strains and further expands Vedanta Biosciences’ patent portfolio after the issuances of three U.S. patents in the previous months and earlier issuances in Japan. The patents are exclusively licensed to Vedanta Biosciences under an agreement with the University of Tokyo and provide coverage through at least 2031.

  • Calif. Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. Like the Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people with wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO). The Lucentis PFS is the first syringe prefilled with an anti-VEGF medicine FDA-approved to treat two eye conditions.

  • Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation announced that data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of investigational oral GED-0301 (mongersen) 160 mg on both endoscopic response and clinical remission in patients with active Crohn’s disease will be presented in Vienna, Austria at the United European Gastroenterology Week (UEGW)

  • Ferring Pharmaceuticals announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for REKOVELLE® (follitropin delta), recommending that the European Commission grants marketing authorisation for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.The European Commission has authority to grant marketing authorisation for medicines in the 28 countries of the European Union (EU). Following a European Commission decision, authorisation can also be granted by national authorities in Norway and Iceland.

  • Quintiles IMS Holdings, Inc. announced that it has successfully completed its merger of equals transaction between IMS Health Holdings, Inc. (NYSE:IMS) and Quintiles Transnational Holdings Inc. The merger of IMS Health, a leading global information and technology services company, and Quintiles, the world’s largest provider of product development and integrated healthcare services, creates a leading information and tech-enabled healthcare service provider with global scale and reach, and a full suite of end-to-end clinical and commercial offerings.

Subscribe to Business Wire