CDC director Rochelle Walensky’s early morning announcement on Sept. 24 recommending boosters for certain frontline workers was considered wise by some but as undermining her advisers and the process by others. She endorsed the Advisory Committee on Immunization Practices’ recommendation for booster doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine but overruled one of the panel’s Sept. 23 decisions by adding boosters for people ages 18 to 64 who are at increased risk of COVID-19 exposure and transmission due to occupational or institutional setting, based on their individual benefits and risks.
The Medicare Coverage of Innovative Technology (MCIT) rule is administratively a dead letter, but the U.S. House of Representatives’ Cures 2.0 legislation would statutorily resurrect the MCIT concept. Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), said automatic coverage of breakthrough devices does not constitute a subversion of the Medicare coverage process, but added that AdvaMed is not opposed to other means of cutting the Medicare red tape, such as greater resources at CMS.
While the FDA has not provided transcriptions for device user fee meetings in roughly five months, the agency is still demonstrably determined to increase the volume of user fees. A source close to the negotiations told BioWorld that the latest proposal from the agency, dated Sept. 22, would require that industry come up with roughly $2.5 billion over the next five fiscal years, more than double the amount under MDUFA IV.
858 Therapeutics Inc. emerged from stealth mode, unveiling $60 million in series A funding and plans to drug a series of protein targets involved in modulating RNA biology in cancer.
Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing.
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
Sight Sciences Inc. may have visions of a substantial settlement following Ivantis Inc.’s $60 million settlement with Glaukos Corp. this week or the Menlo Park, Calif.-based company may have its sights set on knocking a competitor out of the market entirely. Both are possible outcomes of the suit Sight Sciences announced this morning that alleges infringement of four of its patents by Ivantis for its Hydrus Microstent. Sight Sciences makes the Omni surgical system, which competes with the Hydrus and the Glaukos Istent in the minimally invasive glaucoma surgery (MIGS) space.
The FDA reported the elevation of its information technology (IT) office to an agency-level office, a move that gives the agency a heightened priority for eliminating some of the balkanization of computer systems.
The FDA’s Vaccines and Related Biological Products Advisory Committee rejected an sBLA for a third, booster dose of the COVID-19 vaccine Comirnaty from Pfizer Inc.-Biontech SE for ages 16 and over, then unanimously approved a recommendation for those ages 65 and older along with individuals at high risk of severe COVID-19 to get the booster.
Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities.
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