Researchers at ETH Zürich developed Menstruai, a device that detects in menstruation blood biomarkers associated with certain diseases. Menstruai uses a sensor built into a sanitary pad and changes color if certain biomarkers are present. The first of its kind technology has the potential to enable the early detection of diseases and transform women’s health care.
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.
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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.
Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.
The U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency.
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.
While GLP-1 receptor agonists continue to grab the headlines as a treatment option for obesity, another therapy, endoscopic sleeve gastroplasty (ESG), is seeing a steady rise in demand.
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.
Biontech SE and Bristol Myers Squibb Co. are teaming up to develop Biontech’s BNT-327 in a deal possibly worth over $11 billion. BNT-327 is in the hot new class of bispecific antibodies targeting programmed death-1 (PD-1) or its ligand (PD-L1) and vascular endothelial growth factor (VEGF). The bispecifics take advantage of two well established mechanisms of action that help tumors grow; PD-1/PD-L1, which tells immunogenic T cells not to attack the tumor, and VEGF, which tumors excrete to produce new blood vessels to supply oxygen and other nutrients to the tumor.