Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
Recent advances in artificial intelligence (AI) have generated a tsunami of popular dystopian musings, but the U.S. Patent and Trademark Office (PTO) has its own concerns about AI’s impact on intellectual property. PTO recently announced that it is looking for feedback on the use of AI to produce what litigants might spuriously claim is prior art, a concern that must be addressed if the patent system is to avoid crashing under the weight of an unmanageable volume of AI-generated clutter.
Apple Inc. said the U.S. FDA has approved the Apple Watch's atrial fibrillation (AF) history feature under its rigorous Medical Device Development Tools (MDDT) program that specifies what devices health professionals can rely on.
By now, the story of last year’s dismal U.S. capital markets is hardly news. But when combined with increasing regulatory stresses, especially for biopharma and med-tech startups, there are elements of that story giving some Street-watchers pause, even as the market begins to show a few signs of recovery.
Achieving proof of concept and a substantial clinical benefit with its PARP inhibitor stenoparib in advanced recurrent ovarian cancer, Allarity Therapeutics Inc. stopped a phase II trial and is preparing for a registrational study for what is now the company’s only internal drug candidate.
Novartis AG is bolstering its radioligand arsenal with the takeout of Mariana Oncology Inc. for $1 billion up front and as much as $750 million in potential milestone payments. Watertown, Mass.-based Mariana has developed peptide-based radiopharmaceuticals targeting solid tumors. The company’s lead program, MC-339, is a radioligand approach to small-cell lung cancer, due to enter the clinic later this year.
Quest Diagnostics Inc. and Pathai Inc. established a forward-looking deal with multiple components and room for growth. The collaboration includes Quest’s acquisition of Pathai Diagnostics – the division that provides anatomic and digital pathology laboratory services – and licensing of Pathai’s Aisight digital pathology image management system. The companies also said they may work together on development of Pathai’s algorithm products and that Quest will be a preferred provider for Pathai’s biopharmaceutical clinical laboratory services.
The U.S. Federal Trade Commission (FTC) finalized its overhaul of the health breach notification rule (HBNR), significantly expanding the types of software products subject to the agency’s oversight. However, the final rule was approved by the commission by a narrow 3-2 vote and was the subject of a scathing critique by the two dissenting commissioners, who argued that the FTC has once again exceeded its statutory authority in rewriting the HBNR.
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
As Poseida Therapeutics Inc. anticipates reporting further data this year from allogeneic CAR T-cell therapy P-MUC1C-ALLO1, for which Astellas Pharma Inc. has nabbed first negotiation rights, the two companies inked a second deal aimed at combining their respective cell therapy platforms in an early stage collaboration targeting solid tumors.
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