Once again, the U.S. FDA giveth and it taketh away. Just a few days after expanding its approval for Gilead Sciences Inc.’s Veklury (remdesivir) to provide access to more people infected with COVID-19, the FDA essentially shut down the use of two monoclonal antibody (mAb) treatments Jan. 24 that had been authorized to treat mild-to-moderate COVID-19 infections – Regeneron Inc.’s Regen-Cov (Ronapreve in Europe), an antibody cocktail of casirivimab and imdevimab, and Eli Lilly and Co.’s bamlanivimab and etesevimab that are administered together.
Each year, more than 250,000 Americans undergo sinus surgery to treat a range of nose and sinus complaints. Full recovery can take several weeks, during which patients typically use opioids to treat their postoperative pain. Given the risk of opioid addiction, Tivic Health Systems Inc. is testing a bioelectronic device that offers an alternative to potent narcotics following sinus surgery.
The FDA posted a recall of a vaporizer unit that is used in several anesthesia gas machines distributed by Getinge USA Sales LLC, of Wayne, N.J., an issue that has triggered eight complaints. While no injuries or deaths have been reported, this is a class I recall due to the prospect that the problem can trigger irritation of the lung as well as pulmonary edema.
The COVID-19 pandemic has hit supplies and devices across a broad range of categories over the past two years, and the latest addition to the list is the blood collection tube. The FDA announced that this shortage affects all types of blood collection tubes, thus affecting tubes for all uses, not just those used for testing for the SARS-CoV-2 virus.
The good news first. A new U.S. Congressional Budget Office (CBO) report shows that, on average, Americans who can get the treatment they need with generics may be paying less for their prescription drugs than they were a decade ago. The bad news? Those who have no choice other than a brand drug may be paying a whole lot more.
Acutus Medical Inc. provided highlights of a corporate restructuring along with preliminary unaudited revenues for the fourth quarter and year ended Dec. 31, 2021. The company “will prioritize maximizing console utilization and procedure volume growth in targeted geographic regions as well as a more focused scope of product development initiatives.” The restructuring will include the layoff of more than 50 staff members and reduction of manufacturing costs designed to produce annualized operating expense savings of $23 million to $25 million in 2022.
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.
RSS
