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  • Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that its state-of-the-art recombinant biologic manufacturing facility in Singapore received U.S. Food and Drug Administration (FDA) approval to produce ADVATE [Antihemophilic Factor (Recombinant)] bulk drug substance (BDS). The site received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE.

  • NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company, announced that it has received CE Mark approval for its Monarch eTNS System as treatment for attention-deficit/hyperactivity disorder (ADHD) in adults and children age 7 and older. This CE Mark approval is the first for any non-drug treatment of ADHD in the European Union (EU).

  • Coherus BioSciences and Baxalta has recently announced that CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part phase 3 study. This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe chronic plaque psoriasis. Coherus and Baxalta initiated a collaboration to develop and commercialise CHS-0214 in September of 2013.

  • Tata Consultancy Services, a leading IT services, consulting and business solutions firm, today announced the go-live of a comprehensive IT and business transformation program for Australian Pharmaceutical Industries (API), a leading Australian health and beauty company.

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  • Researchers have developed a cost-effective one-step test that can screen, detect and confirm hepatitis C virus (HCV) infections from blood or urine samples. Current blood-based HCV testing requires two steps and can be expensive, inconvenient and is not widely available or affordable globally.

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