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  • Johnson & Johnson receives approval from USFDA and European Commission for SIRTURO (bedaquiline)

    Johnson and Johnson announced that the US Food and Drug Administration has issued traditional approval for SIRTURO bedaquiline as part of combination therapy in adult and pediatric patients 5 years and older and weighing at least 15 kg with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid
  • Novo Nordisk announces 4.1 billion USD investment to expand US manufacturing capacity
    Novo Nordisk today announced plans to invest 4.1 billion US dollars (approx 27 billion Danish kroner) to build a second fill and finishing manufacturing facility in Clayton, North Carolina, and grow its ability to produce current and future injectable treatments for people with obesity and other serious chronic diseases.
  • Suven to acquire a majority stake in an oligonucleotide focused CDMO player, Sapala Organics
    Suven Pharmaceuticals Limited has executed definitive agreements today, i.e. on June 13, 2024, for acquiring 100% of equity shares (on a fully diluted basis) (Proposed Transaction) in Sapala Organics Private Limited.
  • Lupin Achieves Significant Milestone with ISO 14001 and ISO 45001 Certification Across All its Indian Manufacturing Sites, R&D Center and Corporate Office

    Global pharma major Lupin Limited announced that all 12 of its manufacturing sites, its R&D Center and corporate office in India have successfully completed rigorous audits and been certified by DNV for ISO 14001 Environment Management Systems (EMS), and ISO 45001 Occupational Health and Safety Management System (OHSMS). This achievement marks a significant milestone in acknowledging Lupin’s commitment to safe and sustainable operations.

  • Alembic Pharma received EIR for its Oncology Facility

    Alembic Pharmaceuticals Limited received an Establishment Inspection Report (EIR) for its Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.

    On 8th March, 2024, US FDA Inspection at Alembic Pharmaceuticals Limited’s Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.

  • Astrazeneca withdraws COVID-19 vaccine globally

    AstraZeneca announced that it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a surplus of available updated vaccines since the pandemic.

    The company also said it would proceed to withdraw the vaccine Vaxzevria's marketing authorizations within Europe.

  • Lilly Q1 2024 increased by 26 percent driven by Mounjaro, Zepbound, Verzenio and Jardiance

    In Q1 2024, worldwide revenue was USD 8.77 billion, an increase of 26 percent compared with Q1 2023, driven by increases of 16 percent in volume and 10 percent due to higher realized prices. The volume increase was primarily driven by growth from Mounjaro, Zepbound, Verzenio and Jardiance, partially offset by declines in Trulicity.

  • Zydus launches Mirabegron Extended-Release Tablets in the US
    Zydus Lifesciences launches Mirabegron Extended-Release Tablets, 25 mg in the US market. The company had earlier received final approval from the United States Food and Drug Administration USFDA to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg. Mirabegron is indicated for the treatment of overactive bladder OAB with symptoms of urge urinary incontinence, urgency and urinary frequency
  • Novo Nordisk announced results from the kidney outcomes trial FLOW

    Novo Nordisk announced the headline results from the kidney outcomes trial FLOW. The announcement follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD).

  • Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer

    Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

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