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Deals:

Sanofi bought U.K.-based Vicebio for $1.6 billion.

Novartis agreed to pay up to $1 billion to Matchpoint Therapeutics to develop oral drugs for several inflammatory diseases.

Pacira BioSciences announced a strategic collaboration with Johnson & Johnson MedTech to significantly expand the market reach of Zilretta (triamcinolone acetonide extended-release injectable suspension).

Longeveron licensed an issued U.S. patent for a stem cell technology from the University of Miami.

iTeos Therapeutics is being acquired and shut down by Concentra Biosciences.

George Medicines signs exclusive licensing agreement with Azurity Pharmaceuticals to commercialize Widaplik™ (telmisartan, amlodipine and indapamide) tablets in the U.S.

DoseSpot announced a collaboration with Amazon Pharmacy.

Answer ALS launched Louisiana AI Drug Development Infrastructure for ALS, a collaborative initiative aimed at accelerating AI-powered drug discovery for ALS and other neurodegenerative diseases.

Health-Ade Kombucha is being bought for $500 million by Generous Brands. 

FDA:

An FDA panel discussing the use of antidepressants during pregnancy largely amounted to misinformation or facts taken out of context, per physicians following the proceedings.

Sarepta Therapeutics agreed to pause all shipments of Elevidys in the U.S. after stocks fell upon the brand’s initial refusal to comply with the FDA’s request.

The FDA posted a webpage allowing drug companies to indicate their interest in participating in a pilot voucher program that aims to cut product review times down to just one to two months. The agency will be choosing five companies in the first round.

Leo Pharma earned an FDA approval for its JAK inhibitor cream Anzupgo (delgocitinib) for chronic hand eczema.

The agency extended its review of GSK’s blood cancer drug Blenrep as a combination treatment until October 23.

An FDA advisory panel endorsed removing the “black box” warning on hormone treatments for menopause that critics say have discouraged women for decades from using the pills and creams.

Takeda received FDA 510(k) clearance for HyHubTM and HyHubTM Duo devices to simplify Hyqvia administration.

J&J is seeking its first icotrokinra FDA approval for plaque psoriasis.

Roche and Genentech announced the FDA declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL patients who are not eligible for autologous stem cell transplant.

The agency rejected a viral-based treatment from Replimune Group intended for patients with advanced skin cancer.

Funding rounds:

Amneal Pharmaceuticals announced that Amneal Pharmaceuticals LLC is seeking to borrow $1.8 billion aggregate principal amount of new seven-year term B loans under a new term loan facility.

Omega Funds closed its latest funding round at $647 million.

Brandon Capital, an Australian life sciences investor, collected $287 million for the final close of its sixth fund.

Dispatch Bio launched with $216 million – backed primarily by Parker Institute for Cancer Immunotherapy, founded by entrepreneur Sean Parker, and ARCH Venture Partners.

SAB BIO announced an oversubscribed $175 million private placement. 

Pharvaris launched an upsized $175 million public offering.

Avalyn Pharma raised a $100 million Series D financing round.

Phlow, a pharmaceutical contract development and manufacturing organization, closed its $37 million Series C financing round.

CASP, the protein structure prediction contest, secured temporary funding to continue operations from Google-owned DeepMind.

Layoffs:

Rocket Pharmaceuticals announced it is laying off 30% of its employees.

GSK is letting go of 150 workers at its facility in Cambridge, Massachusetts.

Sail Biomedicines is laying off about 36 employees as the company sharpens its focus on immunology. 

Tessera Therapeutics laid off 17% of its staff in its second layoff in the past year and a half. Additionally, fellow Flagship-backed entity Generate:Biomedicines is also letting go of 10% of its workforce. 

Genetech eliminated 87 positions at its headquarters in South San Francisco in another round of layoffs. 

BioNTech is cutting 32 staff members in Gaithersburg, Maryland in another layoff round. 

Sail Biomedicines is letting go of 36 employees. 

Fujifilm Cellular Dynamics is cutting 30 employees at its Madison, Wisconsin location. 

Industry news:

AstraZeneca announced a $50 billion U.S. investment.

Biogen announced a $2 billion manufacturing investment in North Carolina’s Research Triangle Park.

UnitedHealth Group shared it is complying with criminal and civil investigations from the Department of Justice for its Medicare billing practices.

American Academy of Pediatrics guidelines that set off a new era in obesity treatment may have been shaped by pharmaceutical industry influence, a recent analysis suggests. 

Alkermes said its experimental narcolepsy drug, alixorexton, hit key goals in a mid-stage trial.

Humana refiled its Medicare Advantage ratings lawsuit against the federal government. 

Researchers at David Baker’s lab at the University of Washington published data revealing two AI-powered methods to design protein binders for intrinsically disordered proteins which have long been considered undruggable. 

The Health and Human Services Department adopted a recommendation from Secretary Robert F. Kennedy Jr.’s vaccine advisers to remove thimerasol from all influenza shots.

Bristol Myers Squibb said Reblozyl in combination with another therapy failed to meet the main goal of a late-stage trial to treat anemia due to a rare bone marrow cancer.

AstraZeneca’s Tagrisso plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival in EGFR-mutated advanced lung cancer.

A Phase 3 study of AstraZeneca’s gefurulimab hit its primary and all secondary endpoints.

An experimental oral treatment from Abivax helped ease symptoms at compelling rates in patients with a type of bowel disease in a pair of Phase 3 trials.

Thermo Fisher beat quarterly estimates thanks to resilient demand for its tools and services.

Apnimed’s AD109 has now passed the bar in its second Phase 3 study, setting up an FDA filing.

The Pistoia Alliance launched two complementary initiatives.

See last week’s edition of Rx Rundown.