After Study 1’s independent data monitoring committee said the experiment will likely fall short of its primary endpoint with ulixacaltamide in essential tremor, Praxis Precision Medicines Inc. plans to wait for full data from Study 1 as well as Study 2 in the Essential 3 phase III program before deciding on regulatory moves.
About 17 months after emerging from stealth with its Trueglue discovery platform, Magnet Biomedicine Inc. has joined with Eli Lilly and Co. to discover, develop and commercialize molecular glue therapeutics for oncology. “It’s a really important deal, especially given the discovery of Trueglues is something Magnet is pioneering,” CEO Brian Safina told BioWorld. The deal includes $40 million in up-front and near-term payments, including an equity investment, as well as potential milestone payments, bringing the deal total to more than $1.25 billion, plus tiered royalties.
The Apple Watch may be able to alert wearers to heart palpitations, but Google LLC’s Pixel Watch 3 can now detect when a user’s heart stops – and call emergency services. The pulse detection featured received clearance from the U.S. FDA on Feb. 26 and Google plans to make it available on its Pixel Watch 3 starting in March. Pulse detection is already available for watches sold in the U.K. and EU.
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
The BioWorld Biopharmaceutical Index (BBI) ended 2024 down 2.24%, despite hitting a peak of 25.19% in late August. While it remained in positive territory through November, up 3.58%, the steady decline through the later months of the year pushed the index into the red by December’s close.
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
The prospects of an oral obesity candidate used as a monotherapy or combination therapy is in question after Kallyope Inc. posted disappointing phase II data on a government website, indicating that its lead candidate, K-757, failed to meet all endpoints.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
In a flurry of news releases on Feb. 27, Teleflex Inc. reported plans to buy the vascular intervention business of Biotronik SE & Co. for €760 million (US$791 million), said it intended to split into two separate public companies, floated a $300 million accelerated share repurchase program and reported the impending retirement of Chief Financial Officer Thomas Powell. The news sent the company stock down more than 20%.
Basel Medical Group Ltd. is the first Singapore-based med-tech to price an IPO on the Nasdaq this year, aggregating gross proceeds of $8.82 million on its debut. The funds will be used to power future M&As and business expansion plans in Singapore and Southeast Asia, the company said.
RSS
