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• Japan’s Shionogi said it won FDA approval for its oral antiviral to prevent Covid‑19 in adults and children older than 12 years who have been in contact with someone who has Covid.

• The approval for the 3CL protease inhibitor ensitrelvir, known commercially as Xocova, came two weeks ahead of the FDA’s target date.

• The approval is based on a Shionogi-funded study published in the New England Journal of Medicine in May that found the pill, when administered to household contacts of a Covid patient within 72 hours after symptom onset, was effective in preventing the virus in those contacts. (Endpoints)

• The FDA approved Mannkind’s inhaled insulin for use in children ages 6 years and older living with type 1 or type 2 diabetes, marking the first needle-free insulin option for pediatric patients in more than 100 years of insulin therapy.

• The approval expands the existing label for Afrezza, which has been FDA-approved for adult patients since 2014.

• For the millions of children and teenagers who manage their diabetes through multiple daily injections or insulin pump systems, the decision signals a potentially transformative new option at mealtimes. (AJMC)

• The FDA approved an immunotherapy combination therapy for adult patients with Bacillus Calmette-Guérin-naive, high-risk non-muscle invasive bladder cancer (NMIBC).

• The combination of Imfinzi (durvalumab) plus Bacillus Calmette-Guérin (BCG) is the first of its kind to be approved for this patient population, according to AstraZeneca’s press release.

• The combination therapy exhibited significant improvement in disease-free survival vs. BCG alone. (Healio)

• From a business perspective, the victors included Revolution Medicines—hailed by Truist Securities ahead of ASCO as potentially “the next oncology titan”—and the current and apparently still reigning king, Merck.

• Revolution stole the show with a plenary presentation on Sunday that detailed its “unprecedented” pancreatic cancer data.

• Meanwhile, Merck may not have had the splashiest presentations in Chicago over the weekend, but analysts say the data show why the Big Pharma remains king of oncology.

• An experimental cancer cell therapy developed by Legend Biotech helped reduce or eliminate signs of disease in people with lymphoma enrolled in a clinical trial, sparking hopes the “in vivo” medicine might compete with personalized, marketed treatments like Novartis’ Kymriah, the company said Tuesday.

• At the higher of the two dose levels tested so far, all six people treated with the therapy, LB2501, responded. Five had no evidence of lymphoma lesions, according to trial details released ahead of a medical meeting.

• Legend is one of many companies seeking to develop therapies that fight cancer by reprogramming immune cells inside the body.

• If successful, these therapies would sidestep an extensive “ex vivo” process that involves extracting cells and modifying them in a lab. (BioPharma Dive)

• With few treatments available for sickle cell disease, encouraging early clinical data for a Fulcrum Therapeutics drug made it one to watch.

• But another medicine from the same drug class was recently withdrawn from the market due to the risk of causing cancer, and heightened FDA concerns about a potential class-wide risk now leaves Fulcrum with no regulatory path forward for its molecule.

• Based on the FDA’s feedback, Fulcrum decided to discontinue development of its drug, pociredir, the biotech announced after Monday’s market close.

• Fulcrum developed drugs to modulate gene expression to address root causes of genetic diseases. Pociredir is an oral small molecule designed to inhibit PCR2, a protein complex that regulates gene expression.

• Fulcrum said it plans to explore “strategic alternatives” that could include a merger, acquisition, or a sale of its assets. (MedCity News)

• Anti-aging startup NewLimit is back with a fresh fundraise of $435 million after landing on its first clinic-ready candidate years earlier than expected.

• The series C was led by longtime supporter Founders Fund, which was joined by fellow returners like Kleiner Perkins, Eli Lilly Ventures and Human Capital, alongside newcomers Thrive Capital, Greenoaks and Quiet Capital. Founders Fund was co-founded by prominent tech entrepreneur Peter Thiel.

• NewLimit’s team had put immense effort into building a screening platform that allowed them to find and test combinations of transcription factors, proteins that activate different genes, within various cell types.

• While the company initially planned for it to take three or four years to find the right combo to reprogram liver cells to be more youthful, the biotech’s current main focus, the right mix, instead became obvious in months, according to co-founder and CEO Jacob Kimmel. (Fierce Biotech)

• That unique environment also created the breeding ground for one of the industry’s most notable research achievements in space: Merck & Co.’s FDA nod last year for a new formulation of its powerhouse drug Keytruda.

• The breakthrough helped Merck develop the subcutaneous version of Keytruda that offers patients an easier delivery method, while providing the company with a new revenue stream of its best-selling drug as it faces numerous patent cliffs.

“This focus on reformulation has opened up brand new vistas for pharma companies,” said Michael Roberts, chief scientific officer at the ISS National Laboratory.

• As a test kitchen for scientific research, the ISS has played host to a wide range of pharma R&D, including studies into organoids for drug therapy applications.

• What does that mean for the future of drug research in space?