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  • Zydus receives final approval from USFDA for Glatiramer Acetate Injection

    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 acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets
    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 has secured multiple market access agreements for biosimilar to Stelara
    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 to acquire Regulus Therapeutics and farabursen
    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.
  • India has to wait for Sanofi Meningitis vaccine
    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.
  • Human Mixtard penfill to be replaced with injectables, Novo Nordisk clarifies
    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 Secures U.S. Food and Drug Administration IND Clearance for ATI-052
    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 insulin brand from India
    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.
  • Lupin Receives EIR from US FDA for its Injectable Facility in Nagpur
    Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
  • Eplontersen approved in UK
    In people with this disease, small fibres of TTR protein clump together to make deposits called amyloid. Amyloid can build up around or within the nerves, heart and other organs, stopping them from working properly. Eplontersen is specifically indicated for use when the disease is causing polyneuropathy, which is damage to multiple nerves outside of the brain and central nervous system, resulting in pain, discomfort, progressive weakness and loss of sensation in the legs and arms, and mobility difficulties.
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