Deals:
Merck signed a licensing agreement for a heart disease drug with Jiangsu Hengrui Pharmaceuticals worth up to $2 billion.
Clover Biopharmaceuticals said Gavi sent notice of the termination of their vaccine deal and is demanding the return of a $224 million advance payment.
Novo Nordisk is paying $200 million upfront to United Laboratories for obesity drug UBT251.
Bayer acquired rights to Puhe BioPharma’s cancer drug candidate.
Thermo Fisher Scientific announced a technology alliance agreement with the Chan Zuckerberg Institute for Advanced Biological Imaging.
Sermonix Pharmaceuticals and Regor Therapeutics Group announced a strategic collaboration.
Strategic comms firm Reevemark is representing 23andMe in its Chapter 11 bankruptcy filing.
Sunshine Biopharma signed an agreement for rights to market two generic antibiotics.
Ionis Pharmaceuticals expanded its partnership with Sobi to include olezarsen commercialization outside the U.S.
Wanda Health has joined the America Heart Association to advance remote cardiac care.
NeOnc Technologies Holdings announced a strategic partnership with CBCC Global Research to expand NeOnc’s clinical trial capabilities in India.
FDA:
The FDA approved Soleno Therapeutics’ drug designed to treat the worst symptom of a debilitating rare disease known as Prader-Willi syndrome.
The agency approved GSK’s urinary tract infection drug, marking one of the drugmaker’s five expected launches this year.
The FDA once again rejected HLB and Jiangsu Hengrui Pharmaceuticals’ drug combination to treat the most common form of liver cancer due to manufacturing concerns.
The agency is evaluating under priority review the regulatory submission by Sanofi’s tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis.
Sanofi’s chlamydia vaccine candidate was granted fast track designation by the FDA.
The FDA approved Alnylam Pharmaceuticals’ Amvuttra for a rare heart disease.
The agency approved Johnson & Johnson’s Tremfya (guselkumab) as a treatment option for adults with moderately to severely active Crohn’s disease
The FDA approved the Humacyte artificial blood vessel despite warnings.
Precision Biosciences received an investigational new drug designation from the FDA for PBGENE-HBV to treat hepatitis B.
Intellia Therapeutics announced a FDA Regenerative Medicine Advanced Therapy designation granted to Nexiguran Ziclumeran (nex-z) for the treatment of transthyretin amyloidosis with cardiomyopathy
The agency approved Exelixis’ cabozantinib (cabometyx) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.
In an untitled letter, the FDA took aim at clinical data included on a doctor-facing web page for Taiho Oncology’s Lytgobi.
Layoffs:
The Department of Health and Human Services is set to cut 10,000 jobs.
Nkarta Therapeutics axed 34% of staff.
Vaxart laid off 10% of staff.
Lyndra Therapeutics is set to shut down.
Funding rounds:
South San Francisco drug developer Surrozen raised $175 million.
Augustine Therapeutics raised an oversubscribed $85 million Series A financing round.
Tempero Bio raised $70 million.
Boston-based Hillstar Bio raised $67 million in a Series A financing round.
Benitec Biopharma priced $30 million in a common stock offering.
Galatea Bio raised $25 million in total funding.
Industry news:
AbbVie sued Genmab, claiming that the Danish biotech “misappropriated” trade secrets related to antibody-drug conjugate technology developed at AbbVie.
Eisai cut its Leqembi 2027 sales forecast by half but expects “continued growth.”
Havas unveiled its Neurodiversity Center of Excellence.
The Trump administration is shuttering HHS’ long COVID office as part of its reorganization.
The Trump administration also canceled billions of dollars in grant funding to state and local health departments without warning.
An RNA-based drug from Wave Life Sciences increased the production of dystrophin and improved muscle function in 11 patients with Duchenne muscular dystrophy caused by an exon 53 mutation, according to updated Phase 2 study results.
VantAI, a Roivant Sciences spinout, says it has made the first AI model, to its knowledge, that simultaneously predicts biomolecule structures while generating new molecules.
Biogen announced plans for new global headquarters and an innovation hub in Kendall Square.
National Vision Holdings appointed VML as its agency of record following a competitive review.
Inizio Medical, a 2024 MM+M Agency 100 honoree, launched iON.AI.
GSK said it is studying a group of more than 1 million older adults in the U.K. to examine whether Shingrix, its shingles vaccine, lowers the risk of dementia.
Altis Labs, a Canadian health care company, said that its AI tool outperformed the conventional method of predicting overall survival when analyzing scans from a group of lung cancer patients.
West Virginia outlawed foods that contain some artificial dyes or other additives.
Axsome Therapeutics scored in a Phase 3 trial testing Sunosi (solriamfetol) on adults with attention deficit hyperactivity disorder.
LiveWorld, a 2024 MM+M Agency 100 honoree, recorded full-year revenues of $11.3 million, down 1% from 2023.
MedFluencers is partnering with Tulane School of Medicine on the Healthcare Social Media Academy, a social media training program to help medical school students become influential digital opinion leaders.
