The U.S. Federal Trade Commission has posted notice to health care companies that their use of noncompete agreements for physicians and nurses may violate the law. The advisory may allow physicians and nurses engaged in clinical trials to move to other employers, thus complicating the conduct of those trials.
Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alcon, Bonesupport, Covalon, Medtronic, Shiratronics, Tandem Diabetes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Biocartis, Body Vision Medical, Penumbra, Womed.
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.
German bionics leader Ottobock SE & KGaA plans to list on the Frankfurt Stock Exchange by the end of the year in an IPO targeting gross proceeds of €100 million (US$117.7 million). Ottobock would be the fourth European company to go public this year, a good sign for the European med-tech market, which had not seen any since the first half of 2022.
Uncertainties brought on by tariffs have certainly dampened the optimism in the med tech sector seen at the beginning of the year, as it has slowed M&A and fundraising activity. However, companies developing differentiated products based on solid technology, supported by substantial clinical data, will attract financing and M&A activity will return, Luc Marengère, managing partner at TVM Capital Life Science, told BioWorld.