Industry 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.

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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 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.

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.

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.

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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Apricus Biosciences, Inc a biopharmaceutical company advancing innovative medicines in urology and rheumatology,  announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.

Perrigo Company plc and its partner Dexcel Pharma Technologies, Ltd., announced the launch of store brand Omeprazole Delayed Release Orally Disintegrating Tablets 20mg (Omeprazole ODT), an over-the-counter (OTC) medication to treat frequent heartburn. Omeprazole ODT is an FDA-approved medication, featuring MelTech™ melt-in-your-mouth technology, that dissolves in the mouth without water. This product is packaged and marketed as a store brand or retailer 'own label' brand and will provide consumers with a high-quality option for treating frequent heartburn.

Talent demand in India grew by 8% in March 2018. This is the highest growth registered by the recruitment index in the last four months. Compared to last year (from March 2017- March 2018) this year has registered a 9% increase in overall talent demand.  RecruiteX – a monthly hiring trend report by recruitment portal TimesJobs - noted that key industries and functional areas posted a significant rise in talent demand and contributed to this phenomenal rise of 8% in hiring activities in March 2018. Talent demand was highest for professionals with 10-20 years of experience.