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  • Sun Pharma Halol unit gets 10 observations under USFDA Form 483

    US FDA has conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited Halol facility Gujarat from April 26 to May 9, 2022. At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations.

  • Pfizer set up first drug development plant of Asia in Chennai

    US Pharma giant Pfizer has set up its global drug development centre at the Indian Institute of Technology-Madras Research Park with an investment of around 150 crore. This facility employs more than 250 scientists and professionals from a range of scientific disciplines, including Formulation Scientists and Pharmacists, Analytical Scientists, Life Science specialists such as Microbiologists and Biotechnologists, Chemical Engineers, Data Scientists and Program Managers.

  • Biocon Biologics gets USD 90 mn contract from Malaysia to supply insulin

    Biocon Biologics Limited a subsidiary of Biocon Ltd announced that its subsidiary Biocon Sdn. Bhd. in Malaysia has been awarded a three-year contract, valued at USD 90 million* (MYR 375 million), for its recombinant human insulin brand Insugen®, by the Ministry of Health (MoH), Malaysia.

  • Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age

    Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. Food and Drug Administration and that similar requests are underway with international regulatory authorities. The requests are based on a 25 μg two-dose primary series of mRNA-1273.

  • Systemic sclerosis drug of Gesynta Pharma gets Orphan Drug Designation by USFDA

    Gesynta Pharma AB announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's drug candidate GS-248 for the treatment of systemic sclerosis. GS-248 is currently being evaluated in a Phase II clinical trial as a treatment for Raynaud’s phenomenon secondary to systemic sclerosis.

  • Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age

    Pfizer Inc and BioNTech SE submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).

  • Zydus Lifesciences publishes phase 3 results of research molecule, Desidustat

    Zydus Lifesciences announced the publication of two manuscripts detailing the DREAM-ND and DREAM-D Phase 3 study results of Desidustat, a novel HIF-PH inhibitor in the prestigious American Journal of Nephrology.

  • ERYTECH Sells U.S. Manufacturing Facility and Enters Long - Term Supply Agreement with Catalent

    ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the sale of its U.S. manufacturing facility to Catalent, a leading contract development and manufacturing organization (CDMO) in advanced therapies.

  • WHO recommends Pfizers COVID-19 pill

    WHO made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date. However, availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into a major challenge for low- and middle-income countries.

  • Lupin Receives Tentative Approval from U.S. FDA for Tenofovir Alafenamide Tablets

    Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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