Although consensus was not reached on the World Health Organization’s pandemic agreement, the World Health Assembly recognized the progress made by member states to develop a pandemic agreement and to strengthen International Health Regulations (IHR, 2005) during the 77th World Health Assembly meeting held May 27 to June 1 in Geneva.
The U.S. FDA’s draft guidance for control of thermal effects of medical devices may not have broken new conceptual ground, but two trade associations are of the view that the draft is nonetheless expansive in a manner that raises serious questions.
The U.S. FDA has received a citizen petition to grant over-the-counter status to continuous positive airway pressure (CPAP) machines, an oddly timed petition given a recent enforcement action against one of the prime movers in the CPAP space.
Researchers from The Cleveland Clinic Foundation continue to build intellectual property to protect their invention of a portable device for regulating the flow of cerebrospinal fluid (CSF) from a patient.
Unblinding, zealous therapists, severity of harms, abuse potential and actual benefit could all be part of the conversation June 4 when the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee meets in person for the first time since the COVID-19 lockdowns to consider the use of a psychedelic drug, guided by psychotherapy, to treat post-traumatic stress disorder, or PTSD.
Edwards Lifesciences Corp. is selling its critical care product group to Becton Dickison and Co. (BD) for $4.2 billion in cash, forgoing its previously announced plans to spin off the unit into a separate business. The transaction is expected to close before the end of the calendar year.
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.
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