Deals:

Novo Nordisk purchased Cardior Pharmaceuticals for up to $1.1 billion.

AbbVie announced it will acquire Landos Biopharma for $137.5 million.

Johnson & Johnson is in talks to acquire medical-device maker Shockwave Medical, according to The Wall Street Journal.

Gilead Sciences entered into an exclusive license agreement worth $43.5 million with Xilio Therapeutics for its tumor-activated IL-12 program.

Eton Pharmaceuticals bought Pku Golike for phenylketonuria from Relief Therapeutics.

Healthcare commercialization platform Supreme Group acquired Health+Commerce, an integrated marketing and public relations agency.

Indegene bought Trilogy Writing & Consulting GmbH, which provides medical content to life sciences companies.

Cancer drug developer Nuvation Bio plans to buy AnHeart Therapeutics in an all-stock deal.

Eversana and MyHealthTeam announced a collaboration to improve patient diagnosis and treatment times.

Medical Marketing Whiz announced a strategic partnership with JAW Dropping Designs.

Essential Pharma and AcedrA Biopharmaceuticals signed a distribution agreement to commercialize essential medicines in the Middle East and North Africa regions.

DOOH supply side platform Place Exchange partnered with DeepIntent to offer programmatic out-of-home advertising opportunities for healthcare brands.

Pharmazz entered into a license agreement with Dr. Reddy’s Laboratories to commercialize Centhaquine in India. 

Verantos announced a partnership with CuriMeta.

FDA:

In a widely expected decision, the FDA approved Merck’s Winrevair for injection, making it the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH).

The FDA recalled sexual enhancement products containing undeclared prescription drugs like Viagra and Cialis due to health and safety risks.

The agency greenlit Akebia Therapeutics‘ vadadustat to treat anemia caused by chronic kidney disease in dialysis patients.

The FDA approved AstraZeneca’s Ultomiris (ravulizumab-cwvz) as a long-acting C5 complement inhibitor treating patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder.

The agency rejected Regeneron‘s Odronextamab for treating follicular and diffuse large B-cell lymphoma.

The FDA expanded the indication for Gilead Sciences’ Vemlidy (tenofovir alafenamide) to treat chronic HBV infection in pediatric patients.

Verrica Pharmaceuticals said Ycanth received a new chemical entity status and Orange Book listing from the FDA.

The FDA approved Johnson & Johnson’s Opsynvi (macitentan and tadalafil) to treat patients with pulmonary arterial hypertension. The agency also granted a Fast Track Designation to nipocalimab for reducing the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.

The agency greenlit AbbVie’s Elahere (mirvetuximab soravtansine-gynx) to treat patients with certain ovarian, fallopian tube and primary peritoneal cancer.

The FDA approved Invivyd’s Pemgarda, a new COVID-19 medicine for immunocompromised people who are unlikely to have an adequate immune response after vaccination. 

Layoffs:

GSK is set to part ways with most of its Bellus Health employees by the end of the month.

NextCure announced it would lay off 37% of staff.

Bristol Myers Squibb is in the process of laying off 252 employees at its Mirati Therapeutics facility in San Diego.

Catalent announced it will lay off 130 staffers at its Indiana manufacturing plant following its acquisition by Novo Holdings.

Bayer notified 90 employees at its New Jersey headquarters that they would be let go.

Weber Shandwick laid off about 20 people across its New York and Chicago offices as part of a recent “strategic assessment.”

Theratechnologies is cutting an unspecified amount of workers as it pivots to support its drug candidate TH1902.

Funding rounds: 

United Therapeutics’ board of directors authorized a stock repurchase program for $1 billion of common stock.

Stevanato Group announced it expects total gross proceeds from its upsized public offering to be $330 million.

Avenzo Therapeutics raised an additional $150 million in a Series A-1 round.

Pelago, a telehealth clinic service focused on addressing substance use management, announced a $58 million Series C financing round — bringing its total funding to $151 million.

Intellihealth raised $24 million in a funding round. 

Health technology company Tennr raised a $18 million investment from a16z.

Industry news:

Viking Therapeutics said results from an early-stage study of its oral obesity drug showed a 3.3% placebo-adjusted average weight loss after four weeks.

Moderna announced promising new data on several experimental treatments Wednesday — including vaccines for the Epstein-Barr virus and norovirus — as well as a next-generation COVID-19 vaccine in the works.

The company also announced positive results in a Phase 3 trial for an updated COVID-19 shot.

Klick Health, a 2023 MM+M Agency 100 honoree, launched Klick Site AiQ, an AI-supported marketing audit and assessment tool to assist life sciences companies with their brand strategies.

Altimmune cut its hepatitis B program following a Phase 2 trial failure.

Marketing comms agency MullenLowe partnered with Aleve and Mothers Against Prescription Drug Abuse to roll out The Painful Truth to underscore the impact of opioid addiction.

Axsome Therapeutics announced its experimental therapy succeeded in a late-stage trial to treat narcolepsy.

SurvivorNet debuted My Health Questions, an AI-driven platform embedded within the site designed to give people with cancer better answers to their treatment questions.

Praxis said data from a Phase 2a study of photo-sensitive epilepsy patients are positive enough to move its drug into focal epilepsy.

The Advanced Research Projects Agency for Health launched the arm of the Artificial Intelligence Cyber Challenge to enlist AI developers to help discover ways to tackle cyber and ransomware attacks against healthcare systems.

Dr. Jennifer Ashton, the chief health and medical correspondent for ABC News, launched her free weekly newsletter Ajenda.

BioNTech said it received a “notice of default” from the National Institutes of Health over alleged breaches to a license agreement related to the COVID-19 vaccine it jointly developed with Pfizer.

Pfizer also moved its creative from IPG to Publicis after just 10 months.

Pfizer axed one of its two Phase 3 studies evaluating its anti-P-selecting antibody inclacumab in sickle cell disease.

Allergan Aesthetics launched its Moving the Needle on Ethics collaboration with medical aesthetics experts to elevate discussions on ethics in aesthetics.

Stoke Therapeutics said its treatment for Dravet syndrome reduced seizures in an early-stage study.

Pharma commercial optimization platform provider Verix announced its integration of genAI database explorer. 

Norstella named Diffusion as its global PR AOR.

Novocure unveiled positive results from a Phase 3 trial of a medtech device to treat brain metastasis in patients with lung cancer.

See last week’s edition of Rx Rundown.