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.

Boston Scientific Corp. has said pressure from the Delta variant in the U.S. means it is unlikely to hit the lower end of its current third-quarter sales guidance, which calls for 12% to14% organic growth vs. Q320 and 5% to 7% organic growth vs. Q319. Boston Scientific said it expected to still hit the full year sales guidance of 6% to 7% organic vs. 2019 that it issued on July 27 but would continue to monitor the economic and financial impacts of COVID-19. The company noted that the impact of Delta had been mostly in the NW and SE parts of the U.S. while the impact in EU/APAC region had been more modest.

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.

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.