With the recent removal of its amyotrophic lateral sclerosis drug from the market, Amylyx Pharmaceuticals Inc. is looking to revive investor interest with interim data from its phase II Helios study testing the same drug, AMX-0035 (sodium phenylbutyrate plus taurursodiol), in Wolfram syndrome, a rare indication in which Amylyx could be leading the charge.
Exact Sciences Corp., Seekin Inc. and Serum Detect Inc. presented encouraging results for the field of multicancer early detection at the American Association for Cancer Research annual meeting in San Diego April 6-10, but delays in coverage may slow further progress.
Australia’s Speedx Pty Ltd. is launching a new rapid polymerase chain reaction (qPCR) test for 14 different respiratory viruses in a single test that works on almost every commercial PCR platform in half the time and at a fraction of the cost of what its competitors charge.
The U.S. FDA and Department of Justice have announced a consent decree entered into district court that enjoins Philips Respironics LLC North America from manufacturing and distributing respiratory devices from three company facilities in the state of Pennsylvania.
Before formally introducing legislation to spur R&D of treatments for long COVID, the U.S. Senate Health, Education, Labor and Pensions Committee is calling for stakeholder input on the proposal that would require $10 billion in dedicated, mandatory NIH funding to respond to the chronic condition over the next 10 years.
The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.
The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.
Medtronic plc reported data from a head-to-head trial backing its Evolut TAVR system against competitor Edwards Lifesciences Corp.’s Sapien platform, and the data showed particular promise of the Evolut in patients with a small aortic annulus, which would appear to be most beneficial for women in particular.
Routine use of Impella CP in patients who had a heart attack with cardiogenic shock cut mortality by 12.7% at six months compared to standard care, researchers reported in a late breaking presentation at the American College of Cardiology Scientific Sessions in Atlanta.
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