Deals:

Private equity firm New Mountain Capital offered to purchase publicly-traded healthcare technology company R1 for $5.8 billion in cash.

Healthcare tech company Agiliti agreed to be taken private by its majority owner THL Partners in a $2.5 billion deal.

Novo Nordisk announced it will spend $1.46 billion to discover, develop and commercialize molecular glue degraders from San Diego-based biotech Neomorph.

Viatris secured exclusive global development and commercialization rights to two late-stage drug candidates as part of a $350 million research and development collaboration with Idorsia.

Societal CDMO agreed to be acquired by CoreRx.

Veradigm announced it will acquire healthcare AI company ScienceIO for $140 million.

AbbVie announced it will pay $48 million upfront to OSE Immunotherapeutics for an exclusive global license to develop, manufacture and commercialize the antibody, dubbed OSE-230. The French biotech is also eligible for another $665 million in milestones as well as tiered royalties on global net sales.

Takeda Pharmaceutical partnered with India’s Biological E. Limited to boost dengue vaccine production.

GE HealthCare and Biofourmis announced a strategic collaboration to enhance continuity of care in the home.

AstraZeneca shut down most of its roxadustat partnership with FibroGen and returned the investigational asset to the biotech.

BeiGene said its four-target natural killer cell therapy collaboration with Shoreline Biosciences is over.

FDA:

The FDA approved an expanded Indication for Gilead Sciences’ Biktarvy to treat people living with HIV with suppressed viral loads and pre-existing resistance.

Inspectors from the agency found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink.

The agency issued a Complete Response Letter to Minerva Neurosciences’ New Drug Application for roluperidone for the treatment of negative symptoms in patients with schizophrenia, citing four clinical deficiencies.

The FDA announced per- and polyfluoroalkyl substances (PFAS), once commonly found in a range of products, including pizza boxes and microwave popcorn bags, are no longer being used in food packaging in the U.S.

The agency granted priority review to AbbVie for the supplemental Biologics License Application (sBLA) for epcoritamab-bysp.

The FDA issued a refusal to file letter to Theratechnologies for its sBLA for an intramuscular method of administration for the maintenance dose of Trogarzo.

The agency granted an in-person Type-B meeting to Capricor Therapeutics for late March.

Layoffs:

Denali Therapeutics is laying off an undisclosed number of employees and spinning off a small molecule unit. The company also announced a $500 million private placement equity financing.

Perrigo said it is cutting about 6% of its workforce as part of a restructuring plan. 

Swiss biopharma ObsEva announced a wind down of operations.

Thermo Fisher Scientific’s workforce dropped by 8,000 employees over the past year.

Funding rounds: 

Avidity Biosciences announced an oversubscribed $400 million private placement.

Carlyle Group’s life sciences global investment arm Abingworth announced a $210 million strategic development financing agreement with Gilead Sciences.

BlossomHill Therapeutics closed a $100 million Series B funding round.

Kenai Therapeutics announced a $82 Million Series A financing round.

Orbis Medicines launched with €26 million in seed funding from VC fund Forbion and Novo Holdings.

B.well Connected Health raised $40 million in a Series C funding round.

U.K.-based Curve Therapeutics raised £40.5 million in a Series A financing round.

Healthtech company Redi Health raised $14 million in Series B funding.

Healthcare specialist private equity funds hit a peak in commitments last year, according to a recent report from PitchBook.

Industry news:

Revance, maker of frown line treatment Daxxify, has tapped EvolveMKD for work across the company’s aesthetic and therapeutic businesses. In aesthetics, EvolveMKD will oversee a range of activities, including PR, influencer marketing and experiential marketing.

The Department of Justice launched an antitrust investigation into UnitedHealth Group

Zealand Pharma posted strong results from a trial of a liver disease treatment that has been touted as a potential competitor in the booming weight loss drug market.

Real Chemistry’s revenue rose 7% to $595 million, the 2023 MM+M Agency 100 honoree announced.

Viking Therapeutics’ GLP-1/GIP drug showed positive results in weight loss in a Phase 2 study.

Advisers to the Centers for Disease Control and Prevention recommended people at higher risk for the most severe complications of COVID-19 — primarily those ages 65 and older — should receive a booster shot this spring.

Cytokinetics CEO Robert Blum said the company is not for sale.

Sarepta Therapeutics said its Duchenne muscular dystrophy gene therapy Elevidys generated $200 million in its first half-year on the commercial market, but warned of demand flattening.

Novavax reported Q4 2023 revenue and earnings that missed Wall Street’s estimates and said it expects full-year 2024 sales to come in flat or lower than last year.

Syneos Health merged its U.S. PR unit’s corporate communications, reputation and risk management and social impact groups to create a corporate affairs practice.

G1 Therapeutics delivered earnings and revenue surprises of 22.22% and 15.91%, respectively, for Q4 2023.

Sandoz’s U.S. subsidiaries reached a $265 million settlement agreement in generic drug antitrust class action litigation with direct purchaser class plaintiffs.

At least half of adults say racism is a major problem in politics, criminal justice and policing, though a smaller share see racism as a major problem in healthcare, according to a recent survey by the Kaiser Family Foundation.

Advisers to the CDC recommended Valneva’s single-dose Chikungunya vaccine Ixchiq.

Ironwood Pharmaceuticals’ shares dropped sharply despite positive Phase 3 trial results for their SBS drug candidate apraglutide.

Genetic health service provider Panacea announced its launch to challenge 23andMe.

Hims & Hers projected it will record its first profitable year thanks to personalized treatments, including GLP-1 drugs.

GSK announced positive headline results from a pivotal late-stage trial of its gonorrhoea drug, gepotidacin. The British pharma giant also settled another lawsuit on heartburn drug Zantac in California.

Marcus Schindler, Novo Nordisk’s chief scientific officer, said in a media interview that the company is exploring ways its obesity drugs Ozempic and Wegovy could be taken annually rather than weekly.

Elsevier Health launched clinical decision support tool ClinicalKey AI.

BioMarin said it received a subpoena from the Department of Justice for its sponsored testing programs for its rare disease therapies Vimizim (elosulfase alfa) and Naglazyme (galsulfase).

Haleon’s revenue growth accelerated during the final quarter of 2023.

Amgen unveiled a $474 million manufacturing facility in Ohio.

PatientSight launched a subscription service that documents the rare disease patient journey via survey findings.

Verrica Pharmaceuticals reported that Ycanth generated $4.7 million in full-year revenues.

Research published in an American Heart Association journal found that living close to pubs, bars and fast-food restaurants may lead to a higher risk of heart failure.

Arbutus Biopharma’s total revenue dropped from $39 billion in 2022 to $18.1 billion in 2023.

Brand Engagement Network and MedAdvisor Solutions announced a pilot partnership that will bring the former’s AI assistants to certain pharmacies to help enhance patient outcomes.

The American College of Physician Advisors created its Physician Advisor Certification Exam.    

From March 1 to March 15, sexual wellness company Satisfyer will donate 50% of global sales from all purple products on satisfyer.com to the Global Fund For Women.

See last week’s edition of Rx Rundown.