“This was worse than our national election,” Eric Peterson said as he explained his vote Oct. 10 concluding that Stealth Biotherapeutics Inc.’s elamipretide is effective in treating Barth syndrome, an ultra-rare mitochondrial disease that currently affects 129 males in the U.S. Peterson, a vice provost, senior associate dean and professor at the University of Texas Southwestern Medical Center, was one of 10 members of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) who came to that conclusion. Six others had a different opinion. Regardless of which way they voted, the panelists attested to how difficult the decision was.
Glooko Inc. secured a $100 million series F financing to support expansion of its diabetes ecosystem platform, which integrates information from more than 200 devices on a centralized, digital data platform that simplifies care for patients and clinicians. At the same time, the company reported the appointment of Mike Alvarez as CEO.
Abbott Laboratories reported it achieved new major milestones to support the company's growing suite of pulsed field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE study supporting the Volt PFA system, and the launch of the Focalflex trial to assess the company's Tactiflex Duo ablation catheter, sensor enabled, which will be used in the treatment of patients with paroxysmal atrial fibrillation.
SK Bioscience Co. Ltd., of Seongnam-si, South Korea, said Oct. 8 that it will acquire a $3 million stake in Fina Biosolutions LLC to become the first and sole strategic investor of the Rockville, Md.-based vaccine specialist. For SK Bioscience, the investment is slated to boost its vaccine R&D capabilities, the company said, which currently includes manufacturing of pneumococcal and typhoid conjugate vaccines.
With confidence dropping in doing business with China-affiliated life sciences companies due to the Biosecure Act, one of the companies explicitly named in the U.S. legislation is fighting back. Raising the possibility of a constitutional challenge to the bill, Rade Drmanac, co-founder and chief scientific officer of Complete Genomics Inc., wrote to congressional leaders to urge them to remove the California-based subsidiary of MGI from the bill.
The U.S. FDA has issued yet another complete response letter (CRL) for dasiglucagon, a glucagon receptor agonist, being developed by Zealand Pharma A/S for treating congenital hyperinsulinism, an ultra-rare disease that is also being targeted by at least two other companies. This CRL is pegged to the timing of a third-party manufacturing facility reinspection that was done in August and September. The agency also wants some additional clinical analysis from the phase III study.
Shiratronics Inc. raised $66 million in an oversubscribed series B financing round to support completion of its recently launched clinical trial to evaluate the safety and efficacy of its neuromodulation device in patients with treatment-resistant chronic migraine.
Rhythm AI Ltd recently became the latest company to receive U.S. FDA clearance for its artificial intelligenc-based software for optimizing Atrial Fibrillation procedures.
The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.
It’s hard to know where to start in describing the biopharma applications of the 2024 Nobel Prize in Physics. It was awarded to John Hopfield and Geoffrey Hinton “for foundational discoveries and inventions that enable machine learning with artificial neural networks.”
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