Skip to main content

Industry News

 

Clinical courses

 

Clinical research courses

  • Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating

    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV). 

  • FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
    Patients were randomized (1:1) to receive either tisotumab vedotin 2 mg/kg intravenously every 3 weeks or investigator’s choice of chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed, until unacceptable toxicity or disease progression.
  • Gland Pharma receives approval for Edaravone Injection

    Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags. 

    The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Radicava Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma Corporation. 

  • EMA recommends marketing authorisation for Truqap
    The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Truqap, intended for the treatment of locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations.
  • 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.

  • Sanofi has launched GLP-1 drug in India
    Soliqua is indicated as treatment in adults with obesity and type 2 diabetes mellitus, to improve glycemic control as an adjunct to diet and exercise, in those who are insufficiently controlled on oral or injectable therapies.
  • ONO Enters into a Definitive Agreement to Acquire Deciphera Pharmaceuticals

    ONO Pharmaceutical, Co., Ltd and Deciphera Pharmaceuticals, Inc. announced that on April 29, 2024 (Japan time), ONO and Deciphera entered into a definitive merger agreement under which ONO will acquire all outstanding shares of Deciphera common stock for USD 25.60 per share in cash through a tender offer followed by a merger of a wholly owned subsidiary of ONO with and into Deciphera with Deciphera surviving as a wholly owned subsidiary of ONO.

  • Sandoz reaches agreement with Amgen resolving all patent litigation related to its US denosumab biosimilars
    Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti and Wyost, on March 5, 2024. Jubbonti and Wyost are interchangeable with and approved by FDA for all indications of reference medicines Prolia and Xgeva. They have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
  • USFDA approves Pfizer’s BEQVEZ
    BEQVEZ is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month.
  • In-Cosmetics Global Exhibition & Conference 2024 held in Paris
    In-cosmetics Global 2024 is an international exhibition for the cosmetic industry. It is the meeting place for innovation and development in the entire cosmetics sector worldwide. In recent years, the cosmetics industry has significantly shifted towards using active and natural ingredients in beauty products. This trend reflects a growing consumer preference for skincare and makeup formulations that enhance appearance and offer tangible benefits for skin health.
Subscribe to Industry News