While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Baxter, RDIF, Regeneron, Roche, Sensorion, Spero.
Patent subject matter eligibility often seems to overshadow the America Invents Act of 2011 of late despite the controversies over inter partes reviews, but patent attorney Robb Roby told BioWorld that the most important provision of the landmark patent reform legislation may be the provision for prioritized examination. In some instances, this fast-track program has led to a grant of patent in substantially less than a year, a feature Roby said provides a critical turn-around for small companies trying to sustain their appeal to venture capitalists.
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.
Constrained by the U.S. FDA’s authorized conditions of use for a booster dose of Pfizer Inc. and Biontech SE’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled with making recommendations Sept. 23 for the use of the booster, with several members questioning the need for a third dose in some of the populations the FDA identified.
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.
Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan.
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.
Illumina Inc.’s troubled takeover of Grail Inc. is facing further backlash from the European Commission (EC) after the regulator issued a statement of objections to the companies following their alleged breach of the EU Merger Regulation. Illumina’s acquisition of Grail has faced scrutiny from regulators since it was first announced due to concerns the deal could curb innovation and competition.
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