Industry News

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Brekiya dihydroergotamine mesylate injection, the first and only dihydroergotamine autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes.

Senores Pharmaceuticals Limited through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA, has signed agreement today to acquire the USFDA-approved Abbreviated New Drug Application for Topiramate HCl 25, 50, 100 and 200 mg tablets Topiramate from Wockhardt Limited.

Biocon Biologics Ltd , a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced the Company has secured multiple market access agreements for Yesintek™, its biosimilar to Stelara®. The market access agreements from numerous plans represent over 100+ million lives in the United States.

Novartis announced that it has entered into an agreement to acquire Regulus Therapeutics, a San Diego-based, publicly traded clinical-stage biopharmaceutical company focused on developing microRNA therapeutics. Regulus’ lead asset, farabursen.

Sanofi Healthcare India has submitted the application for grant of permission to import Meningococcal vaccine but the subject expert committee of CDSCO requires further information to grant permission.

Novo Nordisk is now discontinuing its Human Mixtard penfill by the year's end. However Mixtard in India will continue to be available in vials. Along with it, other forms of insulin including human insulin from Novo Nordisk will continue to be available in vials & devices for patients across India.

Aclaris Therapeutics, Inc, a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody.

Novo Nordisk to stop selling its top brand Human Mixtard from India which is country's top selling insulin alone Rs. 800 Crore. Human Mixtard comes under DPCO and the company is reported to come up with new products in India.