The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its members to speak on the record, as it ramps up the campaign against paying back over 23% on sales of branded drugs.
Privately held Beckley Psytech Ltd. is to be taken over by Atai Life Sciences in an all-share deal that values the U.K. psychedelic drug specialist at $370 million. After making a $50 million investment in January 2024, Berlin-based Atai already owns 36% of Beckley. It will now issue 105 million new shares to its fellow Beckley investors, giving them 34% ownership of the merged company.
Sanofi SA is to acquire Blueprint Medicines Inc. in a $9.5 billion deal that will give the French pharma ownership of a marketed rare disease immunotherapy heading toward blockbuster status, a follow-on product in phase II/III, and a phase II clinical program relevant to a number of autoimmune diseases.
The EU is having another go at improving access to capital for biotechs and science-based startups, in a bid to enable them to remain anchored in Europe. The Startup and Scaleup strategy, announced on May 28, is a response to the long-running problem that although Europe has strong foundations in its academic research, the innovative companies this science spawns often end up being acquired by U.S. companies, or moving to the U.S. to list on Nasdaq or the New York Stock Exchange.
Researchers in the U.K. have overthrown the orthodox view that childhood cancers have a low mutation burden, opening up new drug targets and opportunities for repurposing existing therapies. In particular, a high mutation rate is associated with a response to cancer immunotherapy. But although PD-1 checkpoint inhibitors are approved for treating pediatric cancers with a high level of microsatellite instability mutations, in general it is thought childhood tumors are not amenable to immunotherapy.
Researchers in the U.K. have overthrown the orthodox view that childhood cancers have a low mutation burden, opening up new drug targets and opportunities for repurposing existing therapies. In particular, a high mutation rate is associated with a response to cancer immunotherapy. But although PD-1 checkpoint inhibitors are approved for treating pediatric cancers with a high level of microsatellite instability mutations, in general it is thought childhood tumors are not amenable to immunotherapy.
Glycoengineering specialist Glycoera AG is preparing to take its extracellular protein degrader constructs into the clinic in the treatment of autoimmune diseases, after closing a $130 million series B.
Glycoengineering specialist Glycoera AG is preparing to take its extracellular protein degrader constructs into the clinic in the treatment of autoimmune diseases, after closing a $130 million series B.
History has repeated itself for Prothena Corp. plc, which has reported a second phase III miss for birtamimab in the treatment of light chain amyloidosis. Announcing the trial failure, the Dublin-based company said it is planning “a substantial reduction” of its organization.
