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  • Montu Patel removed as PCI chief amid corruption allegations
    24 September 2025

    Montu Patel removed as PCI chief amid corruption allegations

    The Union Ministry of Health and Family Welfare has removed Montu Patel from his role as President of the Pharmacy Council of India (PCI), citing that he no longer meets the membership requirements to hold office, The Times of India reported.

    According to the ministry’s order, “Currently, Patel is neither a nominated member under Section 3(h) of the PCI Act, 1948, nor a member of the Gujarat State Pharmacy Council. Hence he ceases to be a member of the Central Council of PCI, thereby also ending his presidentship.”

  • 23 September 2025
    FDA rejects Otsuka and Lundbeck’s bid for REXULTI® in PTSD Treatment
    Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for the use of REXULTI® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).
  • 23 September 2025
    FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
    U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria.
  • 23 September 2025
    FDA moves to approve Leucovorin Calcium for rare neurological disorder linked to Autism

    The U.S. Food and Drug Administration (FDA) has taken a significant step forward in approving leucovorin calcium tablets for the treatment of cerebral folate deficiency (CFD) — a rare neurological condition that disrupts the transport of folate, a vitamin essential for brain development and function.

    Cerebral folate deficiency has been associated with developmental delays, seizures, coordination problems, and autistic features such as challenges in social communication, sensory issues, and repetitive behaviors.

  • 20 September 2025
    USFDA successfully completes inspection at Indoco’s API manufacturing facility at Patalganga with zero observations
    Indoco Remedies Limited announced that the United States Food and Drug Administration successfully completed inspection of its Active Pharmaceutical Ingredients (API) manufacturing facility at Patalganga, Navi Mumbai. The inspection concluded with zero form 483 observations, reflecting the company's commitment to the highest standards of quality, regulatory compliance and operational excellence.
  • 19 September 2025
    Stryker expands its R&D footprint in India with new facility in Bangalore
    Stryker a global leader in medical technologies, announced the expansion of its R&D presence in India with the opening of a new facility in Whitefield, Bengaluru. Building on its existing 220,000-square-foot R&D campus in Gurgaon, the new 140,000-square-foot facility further strengthens Stryker’s footprint in the country.
  • 18 September 2025
    Dr. Reddys launches novel molecule Tegoprazan in India
    Dr. Reddys Laboratories Ltd. announced the launch of the novel molecule Tegoprazan, for acid-related gastrointestinal diseases in India. Dr. Reddys launches Tegoprazan (50 mg) under the brand name PCAB.
  • 18 September 2025
    GSK to invest 30 billion USD in R&D and Manufacturing in the United States over next 5 years
    GSK plc announced plans to invest 30 billion USD across the United States in research and development and supply chain infrastructure over the next five years.
  • 10 September 2025
    USFDA slams Amneal Pharmaceuticals over sterility failures at India facility
    The U.S. Food and Drug Administration, USFDA has delivered a strong criticism to Amneal Pharmaceuticals, issuing a warning letter on August 27, 2025, for serious infractions in manufacturing practices at its Gujarat facility.
  • 10 September 2025
    WHO adds cancer and Obesity medicine in essential medicines - Will India adapt them in NLEM?
    World Health Organization, WHO has released updated editions of its Model Lists of Essential Medicines and Essential Medicines for Children, adding new treatments for various types of cancer and for diabetes with associated comorbidities such as obesity.
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