Pharma News

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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Pierre Fabre Laboratories the 2nd largest private French pharmaceutical group announced that the European Medicines Agency (EMA) has validated the review of the Marketing Authorization Applications (MAAs) for the use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study, which showed that patients who received the combination of binimetinib and encorafenib had a significantly longer progression free survival (PFS) compared to patients receiving vemurafenib.

Dr. Reddy’s Laboratories Ltd. announced that it has launched Cefixime for Oral Suspension, USP 100 mg/5mL and 200 mg/5mL, a therapeutic equivalent generic version of Suprax® (cefixime) for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA).

Bristol-Myers Squibb Company and Pfizer Inc. presented findings from EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF), a Phase 4 clinical trial, during a late-breaking hot line presentation at the ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain. This descriptive, randomized, open-label trial explored the safety and efficacy of apixaban 5 mg twice daily (2.5 mg lower dose when two of the following were present: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133μmol/L)) vs. standard of care (parenteral heparin and/or vitamin K antagonist). The outcomes measured in this study were the occurrence of acute stroke, systemic embolism, major bleeding, clinically relevant non-major bleeding and all-cause death in non-valvular atrial fibrillation patients undergoing cardioversion. This is an investigational use for Eliquis. Eliquis is not FDA-approved for the reduction of stroke in NVAF patients undergoing cardioversion (please see indications and important safety information for Eliquis later in the press release).