Industry News

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.

Pfizer received patent grant for Prevnar 13® in India. The application for grant of patent in India for Prevenar 13 was filed by Wyeth LLC, USA. (a subsidiary of Pfizer Inc., USA) in the year 2007. This was subject to pre-grant opposition challenge before the Intellectual Property Office in India.

The RE-DUAL PCI™ trial explored anticoagulation with Pradaxa® (dabigatran etexilate) dual therapy without aspirin in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement: results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with Pradaxa® when compared to triple therapy with warfarin.1,2 The risk for the primary safety endpoint was 48% lower for Pradaxa® 110 mg dual therapy and 28% lower for Pradaxa® 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events. Both Pradaxa® doses have been approved by regulatory authorities around the world for stroke prevention in AF. The results were presented today as a late-breaker at the ESC Congress 20171 and have been simultaneously published in the New England Journal of Medicine.

Abeona Therapeutics Inc a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation status to the Company’s EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB).  The designation from the FDA enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

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