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  • FDA issues First draft guidance on clinical trials with psychedelic drugs

    U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.

  • USFDA approves First Anti-Inflammatory Drug for Cardiovascular Disease

    AGEPHA Pharma USA, LLC announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved LODOCO as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

  • Lupin Receives EIR from USFDA for its API Manufacturing Facility in Vizag

    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.

  • Lupin Launches Thiamine Hydrochloride Injection USP in the United States

    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.

  • Dr Reddy's Lab completed a GMP inspection with zero observation

    Dr Reddy's Lab completed a GMP inspection with zero observation in Bollaram, Hyderabad plant.

    The United States Food & Drug Administration (USFDA) completed a GMP inspection at our API manufacturing facility in Bollaram, Hyderabad (CTO-3). The inspection was conducted from June 12, 2023 to June 16, 2023. The inspection closed with zero observations.

  • Novartis to acquire Chinook Therapeutics for USD 3.2bn

    Novartis has entered into an agreement to acquire Chinook Therapeutics, a Seattle, WA, based clinical stage biopharmaceutical company with two high-value, late-stage medicines in development for rare, severe chronic kidney diseases.

  • Roche awarded WHO prequalification for the cobas HPV test

    Roche announced that the cobas HPV test for use on the cobas 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions.

  • Lupin gets Health Canada approval of Tiotropium Bromide

    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.

  • FDA approves sotagliflozin for treatment of Heart Failure

    Lexicon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with :
    heart failure or
    type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

  • Milvexian of Janssen Pharmaceutical granted U.S. FDA fast track designation

    The Janssen Pharmaceutical Companies of Johnson & Johnson announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients.

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