Pharma News

Glenmark Pharmaceuticals receives ANDA approval for Clobetasol Propionate Topical Solution USP

  • Posted on: 20 April 2018
  • By: PharmaTutor News

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Topical Solution USP, 0.05%, the generic version of Temovate® Topical Solution, 0.05%, of Fougera Pharmaceuticals, Inc. This product will be manufactured at Glenmark’s Baddi plant in India.


Boehringer Ingelheim and Lilly Collaboration with University of Oxford to Investigate the Effects of Empagliflozin in People with Chronic Kidney Disease

  • Posted on: 20 April 2018
  • By: PharmaTutor News

Boehringer Ingelheim and Eli Lilly to collaborate with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes. The study will be independently conducted, analysed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU). Boehringer Ingelheim and Eli Lilly and Company will provide the funding for the study.


Glenmark to start phase 2b clinical trial for MAB for tratment of Dermatitis

  • Posted on: 19 April 2018
  • By: PharmaTutor News

Glenmark Pharmaceuticals to initiate Phase 2b clinical trial of GBR 830 (Monoclonal Antibody), a novel, investigational treatment for moderate-to-severe atopic dermatitis. The trial’s primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics. Trial enrollment is expected to begin in June 2018.


New mechanisms can predict drug-drug and drug-food interactions

  • Posted on: 19 April 2018
  • By: PharmaTutor News

A Korean research team from KAIST developed a computational framework, DeepDDI, that accurately predicts and generates 86 types of drug-drug and drug-food interactions as outputs of human-readable sentences, which allows in-depth understanding of the drug-drug and drug-food interactions.


New approach to snakebite treatment - looks similar as principles of homeopathy

  • Posted on: 19 April 2018
  • By: PharmaTutor News

Researchers at LSTM's Alistair Reid Venom Research Unit are looking at treatment for snakebite in a completely different way and have shown that it is possible to treat the bite from one snake with antivenom produced from a completely different species that causes the same pathology in humans.


FDA approved Breakthrough Therapy Designation to Hemlibra for haemophilia A without inhibitors

  • Posted on: 18 April 2018
  • By: PharmaTutor News

Roche announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra® (emicizumab-kxwh) for people with haemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.


AstraZeneca to invest $ 90 million in India

  • Posted on: 18 April 2018
  • By: PharmaTutor News

Leading global science-led biopharmaceutical company AstraZeneca today announced its decision of further investing $ 90 million over the next 5 years in India. The announcement was made following a meeting between the company’s Executive Vice President for International Region – Mr. Leon Wang and Honorable Prime Minister of India, Shri Narendra Modi, during the latter’s visit to Sweden, where the two countries signed a joint declaration on innovation partnership for a sustainable future.


FDA grants Crysvita for XLH

  • Posted on: 18 April 2018
  • By: PharmaTutor News

The U.S. Food and Drug Administration approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life.


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