At least one biopharma company is under the magnifying glass in a U.S. Senate Finance Committee investigation into large multinational corporations that shift profits overseas to avoid U.S. taxes.
The U.S. Drug Enforcement Administration (DEA) needs to stop ignoring the 2018 Right to Try Act and stop blocking terminally ill patients’ access to psilocybin, an investigational drug that may provide relief from debilitating anxiety and depression, a bipartisan group of House members said.
With an eye on promoting innovation in complex innovative trial designs, the U.S. FDA published a series of case study examples Jan. 18 from its CID Pilot Meeting Program.
With U.S. merger filings more than doubling between 2020 and 2021, the Federal Trade Commission (FTC) and the U.S. Department of Justice’s (DoJ) Antitrust Division are seeking public input as they begin to modernize federal merger guidelines to better detect and prevent what they consider illegal, anticompetitive deals.
With the evidence that sex and gender both significantly affect the course of many diseases and the function of medical devices rapidly mounting, the FDA’s Center for Devices and Radiological Health (CDRH) released its strategic plan to better understand these differences.
Should the U.S. government be in the business of manufacturing COVID-19 vaccines? Several prominent Democratic senators and representatives would say yes.
Not heeding earlier FDA advice has earned Levo Therapeutics Inc. a complete response letter (CRL) for its NDA seeking approval for intranasal carbetocin (LV-101) in hyperphagia associated with Prader-Willi syndrome (PWS). The CRL followed a 12-1 negative advisory committee vote in November.
That excruciating moment when patients learn their lives are potentially at risk to a “wide neck” brain aneurysm could be softened by results of a long-awaited international study led by researchers at Massachusetts General Hospital (MGH) and Harvard Medical School. According to lead author Adam Dmytriw, wide-neck aneurysms will respond better to the Woven Endobridge Web device than metal stents and blood thinners.
Henley Ion Inc. is encouraged by early testing of a COVID-19 protection device. Henley’s Ion Virus Defender technology uses micronized electrostatic precipitation (mEP) to remove infectious bioaerosols from both inhaled and exhaled air. The company said initial tests of the prototype removed 99.8% of SARS-CoV-2 bioaerosols under Biosafety Level 3 testing conditions.
Intuitive Surgical Inc. benefited from keen interest in resuming surgeries during pandemic troughs and hospitals investing in its Da Vinci robotic system in preparation for a more endemic phase of COVID-19, Intuitive CEO Gary Guthart said in a presentation at the J.P. Morgan 40th Annual Healthcare Conference on Jan. 12. The company’s unaudited preliminary fourth quarter and full year 2021 results also showed strong growth in procedure volumes – 19% year-over-year compared to 2020 and 13% compared to 2019. Still, Intuitive reported that “during 2021, COVID-19 resurgences continued to impact Da Vinci procedure volumes. The impact of the COVID-19 pandemic on the company’s business has, and continues to, differ by geography and region.”
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