It’s taken eight years of jury trials, court reversals and appeals for Amgen Inc. to get the nod to argue its case before the U.S. Supreme Court on what is needed to meet the enablement standard for functional patent claims that envelop a genus.
Verve Therapeutics Inc.’s heart disease candidate, VERVE-101, is the latest gene editing-based therapy to hit a snag at the FDA, which issued a clinical hold, delaying the start of phase I testing in the U.S. News of the hold, which followed preclinical presentations over the weekend at the American Heart Association 2022 meeting, sent shares of Verve (NASDAQ:VERV) falling 30.5% to close Nov. 7 at $21.75.
The American College of Cardiology and the American Heart Association (AHA) released new guidelines for the diagnosis and management of aortic disease just ahead of this year’s AHA Scientific Sessions, which start Nov. 5 in Chicago. The update is the first comprehensive revision to the guidelines since 2010. Key recommendations address screening and diagnostic testing, imaging, patient involvement in care decisions and when to consider surgery.
Shortages of medical devices were not particularly topical before the COVID-19 pandemic, but they have dotted the landscape in the past three years despite the U.S. FDA’s best efforts to manage such issues. The agency recently announced that tracheostomy tubes are now among the device types that are in a state of shortage, a problem created by a paucity of the raw materials used to manufacture these items.
Reflecting statutory and regulatory requirements added over the past five years, the U.S. FDA is issuing a revised draft question-and-answer (Q&A) guidance on expanded access to investigational drugs. One of several guidances recently issued, the 40-page draft incorporates requirements from the 21st Century Cures Act and the 2017 FDA Reauthorization Act that took effect after the current final Q&A guidance was updated in 2017. It also answers new questions sponsors have raised over the past few years.
Nearly six months after ditching its phase II/III COVID-19 vaccination study to chase a booster strategy, Inovio Pharmaceuticals Inc. is now ditching the heterologous booster.
The U.S. FDA announced that it has cleared a new set of tubes used in hemodialysis machines made by Fresenius Medical Care AG & Co., of Bad Homburg, Germany, that are expected to overcome concerns about the previous tubes’ release of potentially toxic biphenyls. The agency acknowledged that it has no reports of adverse events related to the use of these chemicals in the silicone used to manufacture the tubes, stating that its action on this issue is driven solely by animal studies in the medical literature, none of which were cited in the FDA’s Oct. 28 announcement.
With only a week to go before the Nov. 8, 2022 midterm election in the U.S., speculation is growing over what the 118th Congress will look like and what it will mean for the biopharma and med-tech industries. If Republicans flip either chamber, it would prevent either party from using the reconciliation process, which requires the barest majority in the Senate, to pass legislation such as the Inflation Reduction Act with its provisions giving the federal government some control over prescription drug prices.
Nearly six months after ditching its phase II/III COVID-19 vaccination study to chase a booster strategy, Inovio Pharmaceuticals Inc. is now ditching the heterologous booster. The decision to stop internally funding INO-4800 as a booster was made after sifting through data on global demand for COVID-19 vaccines, the condition of the market and Inovio’s own portfolio.
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
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