Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.
The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.
The U.K. government has doubled the rate that pharmaceutical companies must repay on sales of branded drugs, under the statutory rebate scheme, to a record 31.3%. Only 1-2% of total sales of branded drugs fall under the statutory scheme, but the increase is seen as a sign that an ongoing review of the voluntary scheme is not going well.
Philochem AG’s ligand-targeting approach drew to the table Bristol Myers Squibb Co. in a potential $1.35 billion agreement granting BMS subsidiary Rayzebio Inc. exclusive worldwide rights to OncoACP3, a diagnostic and therapeutic candidate targeting prostate cancer.
Three months after dosing the first patient with its dual vector gene therapy, Splicebio SL has closed a $135 million series B to fund the phase I/II trial of SB-007 in the treatment of Stargardt’s disease to completion. Other adeno-associated viru gene therapies for the inherited retinal disorder have entered the clinic, but SB-007 is the first with the capacity to deliver a full version of the ABCA4 gene that underlies Stargardt’s.
Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology.
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.
Aribio Co. Ltd. signed a $600 million license deal with Acino International AG, an Arcera Life Sciences subsidiary, granting the latter commercial rights to its oral Alzheimer’s disease therapy, AR-1001, in select countries including the Middle East.
Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical insights and behavioral tools to help individuals manage their blood pressure.
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