New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.
The American Society of Clinical Oncology (ASCO) meeting opened at the McCormick Place convention center in Chicago with after-lunchtime sessions on breast cancer, melanoma, sarcoma and advancements on adjuvant cancer vaccines. As ASCO revved up, the CEOs of Merck & Co. Inc., Gilead Sciences Inc. and Eli Lilly and Co. vented their frustrations about the impact of the Inflation Reduction Act on innovation.
Ultragenyx Pharmaceutical Inc. anticipates a meeting later this year with the U.S. FDA to discuss a BLA filing for gene therapy DTX-401 as the first potential medical treatment for glycogen storage disease type 1a (GSD1a) after the phase III study hit its primary endpoint and two key secondary endpoints.
Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.
The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons.
Two companies – Head Diagnostics Ltd. and Octave Bioscience Inc. – identified biomarkers that could provide objective assessments of disease progression and response to treatment for patients with multiple sclerosis.
Despite U.S. NIH policy and its peer-review grant process, providing for inclusive enrollment in phase III NIH-funded clinical trials seems to be a check-the-box exercise for many researchers. In a review of a sample of phase III NIH-funded trials conducted between 2016 and 2020, the Health and Human Services Office of Inspector General found that two-thirds had the required inclusive enrollment plans, but 57% of the trial plans provided no explanation or rationale for the enrollment targets.
South Korea’s Hanall Biopharma Co. Ltd., of Songpa-gu, Seoul, agreed to an exclusive licensing deal with San Francisco-based Turn Biotechnologies Inc. to develop novel ophthalmic and optic therapies using the latter’s mRNA-based technology.
The problem of counterfeit devices has perplexed the U.S. FDA for some time, given that the agency had previously been forced to send the illicit products back to the originator, only to see the same devices reenter the U.S.
Surmodics Inc. reported plans to be acquired by private equity firm Golder, Thoma, Cressey, Rauner Inc. for $43 a share for a total equity valuation of approximately $627 million. The per-share acquisition price represents a 41.1% premium to Surmodics’ 30-trading day volume-weighted average closing price through May 28, 2024.
RSS
