Industry News

The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

Myriad Genetics, Inc a leader in molecular diagnostics and personalized medicine, announced that two important studies will be featured in podium presentations at the 36th annual conference of the National Society of Genetic Counselors (NSGC) in Columbus, OH.

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AstraZeneca announced full results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial that showed cardiovascular safety with Bydureon (exenatide extended-release) in patients with type-2 diabetes (T2D) at a wide range of CV risk.

Pharma Major Lupin announced that it has received final approval for its Metronidazole Tablets USP, 250 mg and 500 mg from the United States Food and Drug Administration (FDA) to market a generic version of G.D. Searle LLC's Flagyl® Tablets, 250 mg and 500 mg.

Ramucirumab plus docetaxel improves progression-free survival in patients with advanced or metastatic urothelial cancer who have progressed on platinum-based chemotherapy, according to late-breaking results from the phase III RANGE trial presented at the ESMO 2017 Congress in Madrid  to be published in The Lancet.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg, the generic version of Rythmol SR® Capsules, 225 mg, 325 mg, and 425 mg, of GlaxoSmithKline, LLC.

Panacea Biotec, India's highly progressive research based health management Company, has expanded its existing collaboration with Apotex Inc., the largest Canadian-owned pharmaceutical company, for sales & distribution of Prasugrel 5mg and 10mg tablets (generic version of Eli Lilly's Effient) in the USA.

“Biocon´s subsidiary in Malaysia, Biocon Sdn. Bhd., has been issued a Certificate of ´GMP Compliance´ for its Insulins manufacturing facility by the HPRA (Ireland) as the representative European inspection authority.

GSK announced that it has exercised the option to obtain an exclusive global license from Adaptimmune for an investigational SPEAR T-cell receptor therapy targeting NY-ESO-1 (GSK3377794). Upon exercise of this option and transition of the programme, GSK will assume responsibility for all development, manufacturing and commercialisation activities for the asset.

MacroGenics, Inc. a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced the presentation of clinical data from its Phase 1 study of flotetuzumab in an oral session at the European Society for Medical Oncology Annual Congress, ESMO 2017, in Madrid, Spain. Norbert Vey, M.D., Team Leader Translational Medicine – Hematology at Institut Paoli-Calmettes, Marseille, France, presented "Interim Results from a Phase 1 First-in-Human study of flotetuzumab, a CD123 x CD3 bispecific DART molecule, in AML/MDS."