The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has licensed an indication extension to Blincyto (blinatumomab) to treat adults with Philadelphia chromosome negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase. 17 December 2024
Belgian drugmaker UCB today announced the ORCHESTRA proof-of-concept study of minzasolmin - an investigational, oral small molecule, alpha-synuclein misfolding inhibitor - developed in partnership with Novartis for early Parkinson’s disease, did not meet its primary and secondary clinical endpoints. 17 December 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for a fixed combination of Rybrevant (amivantamab) and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. 17 December 2024
Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
Dewpoint Therapeutics and ConcertAI have announced the first phase of their translational oncology partnership, aligned around the former company's latest drug candidate, DPTX3186. 16 December 2024
Chinese biotech RemeGen has presented results from a Phase III trial of disitamab vedotin, a HER2-targeted antibody-drug conjugate (ADC), at the San Antonio Breast Cancer Symposium. 16 December 2024
The schizophrenia market across the seven major markets is poised to grow at a compound annual growth rate (CAGR) of 7.4% from $8.4 billion in 2021 to $17.0 billion in 2031, driven by the anticipated introduction of 11 late-stage pipeline products during the forecast period. 16 December 2024
Bicycle Therapeutics, a UK-headquartered pharma company developing a new class of therapeutics based on its proprietary bicyclic peptide technology, closed a third lower on Friday. 16 December 2024
VectorY Therapeutics, a Netherlands-based biotech focused on neurodegenerative diseases, has appointed Jim Scibetta as chief executive officer. 16 December 2024
The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for the treatment of early Alzheimer’s disease (AD). 5 December 2024
Venture capital firm BC Partners has entered into an agreement under which the private equity business at Goldman Sachs Alternatives will acquire a majority stake in Netherlands-based Synthon, from funds advised by BC Partners. 17 December 2024