Industry News

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.

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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.

Dr. Reddy’s Laboratories Ltd. has launched Bupropion Hydrochloride Extended-Release Tablets, USP (XL) and Metaxalone Tablets which are approved by the U.S. Food & Drug Administration (USFDA).

Janssen Pharmaceutica NV entered into an exclusive distribution agreement for INVOKANA® (canagliflozin) and VOKANAMET® (a fixed-dose combination of canagliflozin and metformin) in countries in the European Economic Area (EEA) and Switzerland where the products have obtained Pricing and Reimbursement Approvals. The agreement with Mundipharma Medical Company (“Mundipharma”) became effective on 21st August 2017 in all concerned countries except in the UK and Italy where the agreement will become effective on 16 September.

ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, announced that two abstracts on its preclinical erymethionase and eryminase programs were accepted for poster presentation at the 13th International Congress of Inborn Errors of Metabolism (ICIEM), being held September 5 – 8, 2017 in Rio De Janeiro, Brazil.

Zydus Cadila has received the final approval from the USFDA to market Donepezil Hydrochloride Tablets, in the strength of 23 mg. The drug is indicated for the treatment of dementia of the Alzheimer’s disease.

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The drug will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

GN Hearing announced the launch of ReSound ENZO 3D™, and the corresponding Beltone Boost Max™, which brings the renowned benefits of ReSound LiNX 3D™ and Beltone Trust™ to people with severe to profound hearing loss. Based on GN Hearing’s 5th generation 2.4 GHz wireless technology and GN Hearing’s 3rd generation binaural directionality, ReSound ENZO 3D has been proven to allow users to experience 60% more clarity of the sounds around them* and 60% better speech understanding in noise.