The industry in the U.K. is starting to get concerned about the U.S. Biosecure Act and the possible impact on its ability to use Chinese service providers, and the implications for future dealmaking with U.S.-based companies.
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.
Flindr Therapeutics BV has raised €20 million (US$21.4 million) in a series A round to advance small-molecule immune modulators aimed at targets it has identified in cancer patients who respond to existing immunotherapies.
Vertex Pharmaceuticals Inc. has tapped into Treefrog Therapeutics SA’s high-throughput stem cell manufacturing technology in a deal worth potentially up to $780 million to help it advance its type 1 diabetes programs, including phase I/II asset VX-880.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
Newco Outrun Therapeutics Ltd. has raised $10 million in a seed round to develop small-molecule E3 ubiquitin ligase inhibitors that prevent programmed protein degradation. The lead program targeting an E3 ligase that tags a tumor suppressor protein for destruction will now advance to preclinical development.
Oncolytic virus specialist Theolytics Ltd. has raised £19 million (US$23.7 million) in its latest financing round, as it prepares to start phase I development of the lead product, THEO-260, later this year.
“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.
Essential Pharma Ltd. is paying up to £70 million (US$88.7 million) to acquire Renaissance Pharma Ltd., taking ownership of Hu14.18, a treatment for high-risk neuroblastoma. The antibody has completed a 64-patient phase II trial conducted by St Jude’s Children’s Research Hospital, in which it showed an improvement in overall survival of around 50% compared to currently available therapies.
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