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.
GE Healthcare has introduced an all-digital PET/CT System featuring a new category of digital BGO (crystal-based gamma ray detection) employing a smaller crystal size to deliver greater spatial resolution than other digital scanners. Pitched at the European Association of Nuclear Medicine’s annual meeting in Barcelona on Oct. 16, Omni Legend was designed to accelerate scan times and has demonstrated, according to GE Healthcare global chief marketing officer Sonia Sahney, “impressive small lesion detectability.”
The U.S. FDA’s interest in regulating lab-developed tests (LDTs) occasionally prompts the agency to engage in a little saber-rattling about rulemaking if Congress should fail to pass legislation granting the FDA explicit authority to regulate these tests.
Device makers often need the assistance of physicians to aid in device design and development, but this is a practice that comes with some legal hazards. A session held here in Boston on enforcement in the U.S. made clear that manufacturers must exercise caution in these consulting arrangements, such as documenting the need for outside help with the device, lest the manufacturer end up with a hefty, multimillion-dollar fine imposed by U.S. enforcement agencies.
At the Saturday, Oct. 22 session, ‘Basic Science: Correlates of protection, immune response and the host-microbe interaction,’ of the IDWeek 2022 infectious disease conference, moderator Luiz Bermudez, professor at Oregon State University, introduced the latest advances to prevent infections with Treponema pallidum during neurosyphilis (NS), Staphylococcus aureus and osteomyelitis, and Mycobacterium tuberculosis during influenza.
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