Pharma News

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."

Gecko Biomedical a medical device company developing innovative polymers to support tissue reconstruction, announced today that it has received CE Mark approval for its SETALUM™ Sealant allowing the company to market its technology in Europe.

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 advancement of two of its proprietary bispecific DART product candidates. This progress includes: a first patient has been dosed with MGD013, a DART molecule that recognizes PD-1 and LAG-3; and the submission of an Investigational New Drug (IND) application with the FDA for MGD014, a DART molecule that targets HIV-infected cells and CD3. MacroGenics retains worldwide rights to both of these product candidates.

Boehringer Ingelheim and Gubra announce a collaboration and license agreement for the development of novel peptide compounds to treat obesity. The collaboration will bring together Gubra’s expertise in the design, synthesis, characterization and in in vivo testing of therapeutic peptides with Boehringer Ingelheim’s expertise in the development of innovative medicines for patients with cardiometabolic disease. It further expands and complements Boehringer Ingelheim’s comprehensive research and development portfolio in cardiometabolic diseases, one of the company’s core focus areas.

ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the presentation of the full data from its Phase 2b study evaluating eryaspase (GRASPA®) in combination with chemotherapy for the treatment of metastatic pancreatic cancer. The open-label, multi-center, randomized Phase 2b clinical study met its co-primary endpoints and demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS). The results will be presented during the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid.

Bioverativ Inc a global biotechnology company focused on the discovery, development and commercialisation of innovative therapies for haemophilia and other rare blood disorders, and Bicycle Therapeutics Ltd., a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, today announced a research collaboration focused on the discovery, development and commercialisation of innovative therapies for haemophilia and sickle cell disease.