An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC. Read More
The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot. Read More
Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated. With millions of women suffering from the debilitating condition globally, maraciclatide has the potential to not only help with diagnosis but also with the development of new therapeutics, David Hail, CEO of Serac, told BioWorld. Read More
Scientists at the Weizmann Institute of Science in Israel announced the discovery of the new intestinal microbiota species Kazachstania weizmannii in mice, which competed with and limited the growth of Candida albicans, thus preventing candidiasis. Both microorganisms belong to the Saccharomycetaceae family and reside in humans, maintaining a complex interaction with therapeutic value. Read More
The latest filing from Orlando-based Noble International Inc.—an Aptar Pharma company—hints at the development of a new category of medical devices. Best known for its medical device training solutions and patient onboarding strategies, Noble filed for protection of a compression sleeve for monitoring and treating rheumatic disorders. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ibex Medical Analytics, Lucid Diagnostics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, J&J, Johnson Matthey, Hatch Medical, Pavmed, Serf, Setpoint, Siemens, Stryker. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Butterfly Network, Intuitive Surgical, Sequel. Read More
