FDA

  • Royalty Pharma acquires Nuvalent cancer drug royalties in $315 million deal

    NEW YORK – Royalty Pharma plc said on Tuesday it acquired a royalty interest in two of Nuvalent Inc’s experimental lung cancer therapies for up to $315 million, betting on the drugs’ multi-billion dollar sales potential. The deal gives the royalty investment firm a low-single-digit percentage of worldwide net sales for neladalkib and zidesamtinib,…

  • Ipsen will acquire ImCheck Therapeutics for up to 1 billion euros

    PARIS: Ipsen and ImCheck Therapeutics today announced they have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid…

  • TrivarX to acquire brain imaging tech from Nucleics

    SYDNEY: TrivarX Ltd (ASX: TRI) said on Thursday it will acquire the intellectual property for Stabl-Im™, a novel brain cancer imaging technology, from Australian biotech firm Nucleics Pty Ltd, in a deal aimed at expanding its diagnostics portfolio into neuro-oncology. The Perth and Minneapolis-based company has entered a binding option agreement to acquire 100%…

  • Biotron to acquire Sedarex

    SYDNEY: Biotron Limited (ASX:BIT) announced Wednesday it will acquire Sedarex Limited, a company holding global patents for SedRx™, a next-generation general anaesthetic, in a transaction supported by a $2.5 million capital raising. The acquisition includes an initial issuance of 500 million Biotron shares, valued at $1.5 million, with additional milestone-linked shares tied to regulatory…

  • Shield Therapeutics reports strong H1 2025 results; Eyes cash flow positivity by year-end

    LONDON: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company focused on iron deficiency, reported a sharp rise in revenues and prescription sales for the first half of 2025, as its flagship product ACCRUFeR® gained traction across key markets. Group revenues surged to $21.4 million, up 1.8 times from $12.1 million in H1 2024,…

  • N4 Pharma reports 2024 financial results

    LONDON: N4 Pharma plc (AIM: N4P), a UK-based biotechnology company developing its proprietary Nuvec® gene delivery system for advanced cancer and disease therapies, announced its audited financial results for the year ended Dec. 31, 2024. The company’s annual report and notice of its annual general meeting (AGM) have been distributed to shareholders. The AGM…

  • Alzheimer treatment granted fast track designation by the FDA

    STOCKHOLM: BioArctic AB’s partner Eisai announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast…

  • FDA Approves initiation of IGC’s cannabinoid trial on Alzheimer’s patients

    POTOMAC: India Globalization Capital announced that on July 30, 2020, the U.S. Food and Drug Administration (FDA) notified IGC that it has authorized the Company to initiate a Phase 1 human trial study for the Company’s investigational cannabinoid formulation for the treatment of patients suffering from mild to severe dementia due to Alzheimer’s disease.…

  • IQ-AI receives FDA clearance to market StoneChecker software

    LONDON: Imaging Biometrics, IQ-AI’s Milwaukee based subsidiary, received notification that the FDA has cleared StoneChecker Software for marketing in the USA. David Smith, Chief Executive of the operating subsidiaries of IQ-AI stated, “We are delighted that after an exhaustive review of the product, that the FDA has cleared the product for marketing in the…

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