Biotech news, week of October 26, 2026

Machine summary Four CDER officials, including the directors of the Office of Neuroscience and its Division of Psychiatry, published the FDA's "new framework for psychedelic drugs" in the New England Journal of Medicine on September 10, the National Law Review reports. The Division of Psychiatry reviews the majority of psychedelic drug applications, according to the article, which reports the commentary combines previously covered ground with new elements.

1. On September 10, four FDA Center for Drug Evaluation and Research officials published a commentary in the New England Journal of Medicine presenting what they call the agency's "new framework for psychedelic drugs," the National Law Review reports.
2. The authors are Michael Davis, CDER Center Director; Teresa Buracchio, director of CDER's Office of Neuroscience; Tiffany Farchione, director of that office's Division of Psychiatry; and Bernard Fischer, the division's Deputy Director.
3. According to the National Law Review, the Division of Psychiatry reviews the majority of psychedelic drug applications submitted to the FDA.
4. According to the National Law Review, Davis held the Chief Medical Officer post at the Usona Institute, a nonprofit that develops psychedelic drugs to treat depression and PTSD, between 2022 and 2025, then went back to the FDA and was appointed the Center's permanent director.
5. The commentary highlights major depressive disorder and PTSD and states that existing treatments do not work for many patients, the article reports.

Reported by The National Law Review and National Law Review.

• Center for Drug Evaluation and Research
• New England Journal of Medicine
• Usona Institute
• psychedelic drugs

Machine summary The same report notes an FDA label update for Amgen's IMDELLTRA and an FTC amicus brief filed in litigation over Amgen's Enbrel patents.

1. Per the report, the FDA has broadened Vertex's Casgevy therapy so its approved indications now cover patients starting at two years old.
2. Vertex finalized its acquisition of Crinetics Pharmaceuticals, the report states.
3. Amgen received FDA approval for an IMDELLTRA label update, according to the report.
4. The Federal Trade Commission filed an amicus brief in litigation concerning Amgen's Enbrel patents, the report states.
5. The report's commentary says the fourth quarter tends to be the strongest for healthcare companies because consumers fill prescriptions after meeting insurance deductibles that reset in the first quarter.

Reported by fool.com and The Motley Fool.

• FTC
• Amgen
• Crinetics Pharmaceuticals
• Casgevy
• Enbrel
• IMDELLTRA

Machine summary IAVI announced a US $36 million initial award within a contract valued up to US $99 million from ASPR/BARDA to advance a one-dose Bundibugyo virus vaccine candidate through process development, manufacturing and clinical evaluation. According to the announcement, the program aims to supply for a ring vaccination trial planned in the DRC, following Phase 1 evaluation.

1. IAVI announced on October 28, 2026 an award of US $36 million under a contract valued up to US $99 million from ASPR/BARDA within the U.S. Department of Health and Human Services
2. The award provides funding to advance process development, manufacturing, and clinical evaluation for a one-dose Bundibugyo virus vaccine candidate, encompassing a Phase 1 trial, plus options for expanded manufacturing.
3. Named partners in the program are Hilleman Laboratories (Singapore), SK bioscience (Incheon, South Korea) and IDT Biologika (Dessau-Rosslau, Germany), with IAVI leading
4. The announcement stated that, as of October 25, 2026, the DRC epidemic had 10,060 confirmed cases and 4,887 deaths.
5. BARDA granted IAVI $36 million to develop a vaccine against Bundibugyo virus. According to the announcement, neither approved vaccines nor specific treatments exist for illness caused by Bundibugyo virus, and a single-dose vaccine conferring immunity quickly was characterized as a major unmet need.

Reported by sierraleonepress.com and Yahoo Finance.

• U.S. Department of Health and Human Services
• Bundibugyo virus
• BARDA
• ASPR
• IDT Biologika
• Bundibugyo virus vaccine candidate

Machine summary Illumisoft announced on October 28, 2026 a planned CHAIR-led research program of 13 linked studies evaluating its SaniLume upper-air ultraviolet disinfection device in Canadian hospitals. The University of Waterloo will collaborate on two initial studies: one, a bioaerosol chamber experiment that contrasts hospital ventilation rates when upper-air UV is used against when it is absent, and another that employs computational fluid dynamics to examine air movement within clinical spaces.

1. Illumisoft Lighting Corp. (TSXV: UVC, OTCQB: FUVCF) announced on October 28, 2026 that it collaborated with CHAIR to develop plans for a Canadian hospital research program evaluating SaniLume, its upper-air ultraviolet disinfection device.
2. According to the company, CHAIR has signed non-binding letters of intent for planned facility-wide SaniLume installations alongside Winnipeg's Health Sciences Centre and Shared Health, situated in Manitoba, as well as British Columbia's Provincial Health Services Authority.
3. A program that is planned includes 13 interconnected research projects, the first two of which involve the University of Waterloo. One is a chamber experiment on bioaerosols that compares how hospital ventilation performs with and without upper‑air UV, while the other uses computational fluid dynamics to model airflow within clinical areas.
4. According to the release, the initiative aims to assess how SaniLume influences airborne pathogens, surface contamination, and the spread of respiratory viral illness.
5. CHAIR plans to start studies in November 2026, contingent on funding that, according to the company, remains unsecured.

Reported by Yahoo Finance and stratfordbeaconherald.com.

• SaniLume
• Health Sciences Centre (Winnipeg)
• Provincial Health Services Authority
• University of Waterloo
• CHAIR (Coalition for Community & Healthcare Acquired Infection Reduction)
• Shared Health

Machine summary An FDA proposed rule would change the specifications for four of the 30 nutrients required in US infant formula: iodine (5 to 15 micrograms, new 50-microgram cap), manganese (5 to 1 microgram per 100 calories, new 50-microgram cap), vitamin A (250 to 233 IU per 100 calories) and vitamin D (1 to 2 micrograms, new 3-microgram maximum). Reuters reported the proposal also includes labeling rules, and vitamin A's unit of measure would shift from international units to retinol activity equivalents.

Reported by Reuters, NBC News, HHS.gov, Contemporary Pediatrics, news8000.com, MyCentralOregon.com, Food Processing and AP via Scripps News Group.

• Operation Stork Speed
• Retinol activity equivalents (RAE)

Full coverage: every report, when each was published, and who was named (8 outlets)

Machine summary The company has started a registration trial to expand Ryoncil, approved for steroid-refractory acute graft-versus-host disease in children, to adults with the same condition. It expects up to 40 U.S. trial sites to be activated this year.

1. The report indicated that net operational cash spending dropped 86% to $2.1 million during the quarter, compared with $14.9 million in the same period a year before.
2. Mesoblast held about $99 million in cash at the end of September, the report states
3. On the Australian Securities Exchange that same day, the stock climbed 23.4% to A$2.32, and was described as the best performer of the session on the Australian market.

Reported by Yahoo! Finance Canada and ibtimes.com.au.

• Nasdaq
• Australian Securities Exchange
• Mesoblast
• Yahoo! Finance Canada
• Ryoncil