Deals:
Sanofi entered into a co-exclusive licensing agreement with Novavax to sell the biotech’s sell COVID-19 vaccine going forward and develop novel flu-COVID combination shots.
The French drugmaker also announced it will pay $80 million upfront to acquire the ex-U.S. license to Fulcrum Therapeutics’ rare neuromuscular disease treatment candidate.
Additionally, the company selected Sartorious as its preferred partner for development and commercialization of integrated and continuous biomanufacturing platforms.
Johnson & Johnson announced it will acquire Proteologix for $850 million in an all-cash deal.
Blackstone said it will commit up to $300 million to support the portfolio company Uniquity Bio and its former Merck monoclonal antibody being tested for asthma and COPD.
Maze Therapeutics announced that Japanese pharma company Shionogi had licensed its experimental Pompe disease treatment MZE001, with an upfront payment of $150 million.
Novo Holdings announced it is buying a majority stake in Austrian life sciences tools company Single Use Support.
AbbVie and Gilgamesh Pharmaceuticals agreed to a collaboration and option-to-license deal to develop next-generation psychiatric disorder treatments.
Takeda announced it will pick up an Alzheimer’s drug from neurodegenerative disease biotech AC Immune for $100 million upfront.
Multiply Labs and Retro Biosciences announced an $85 million commercial and supply agreement.
Enveric Biosciences signed a non-binding term sheet to out-license a class of novel psilocin products to MinBio Therapeutics for up to $66.5 million in milestone payments.
Kenvue added Interpublic Group’s FCB and Omnicom’s BBDO to its global agency roster.
Italian corporate affairs advisory group Excellera Advisory Group acquired corporate comms shop Barabino & Partners.
IMMY bought OLM Diagnostics.
Healthcare identity resolution provider Throtle and multi-channel programmatic advertising StackAdapt announced a partnership.
GoodRx signed a new direct contracting agreement with Kroger.
Bio Conscious Technologies announced an API Integration with Dexcom.
Lindus Health announced a partnership with Acinonyx Bio.
Galapagos and Blood Centers of America announced a strategic collaboration to boost the former’s decentralized CAR-T manufacturing network in the U.S.
FDA:
The FDA approved a new way for people to screen for signs of cervical cancer, based on devices created by BD and Roche.
The agency initiated another recall of a Philips product due to a power malfunction that would cause the Trilogy EVO Continuous Ventilators to fail.
The FDA delayed the potential approval date for Moderna’s RSV vaccine.
Dynavax Technologies said the FDA declined to approve the expanded use of its hepatitis B vaccine in patients undergoing hemodialysis, citing insufficient safety and effectiveness data.
The agency warned consumers to not use Cue Health’s at-home COVID-19 tests.
Indica Labs said it received FDA clearance for HALO AP Dx, an enterprise digital pathology platform.
Ascendis Pharma announced that the agency delayed its decision on Ascendis’ hypoparathyroidism drug, TransCon PTH, due to a “major amendment” on the application.
Layoffs:
Bayer laid off 1,500 employees, including those working in its pharmaceuticals and consumer health divisions.
Ginkgo Bioworks said it is planning a 25% reduction in labor spending across both research and development as well as general and administrative departments.
Contract development and manufacturing organization AGC Biologics announced it is laying off just under 4% of its workforce.
WuXi AppTec cut a small number of roles at a facility in St. Paul, Minnesota.
BioMarin said it will lay off about 170 workers worldwide.
Funding rounds:
Healthcare payments software company Waystar is seeking to raise as much as $1 billion in an initial public offering as soon as next month.
Sand Capital closed its $555 million life sciences investment fund.
Bain Capital Life Sciences, Atlas Venture, RTW and Lyra Capital invested $400 million in a new biotech named Hercules CM NewCo.
Growth equity firm NewVale Capital announced its $167 million fund.
iTeos Therapeutics announced a $120 million registered direct offering.
Allogene priced a $110 million common stock offering.
Lycia Therapeutics raised $106.6 million.
Ajax Therapeutics raised $95 million in a Series C financing round.
CinDome Pharma raised an additional $40 million in a Series B extension.
Brixton Biosciences raised $33 million in a Series B funding round.
Nabla Bio formed drug discovery collaborations with AstraZeneca, Bristol Myers Squibb and Takeda while raising $26 million in funding.
Medical device company Meacor closed a $15 million Series A funding round.
Phenomix Sciences raised $7.8 million in a Series A funding round.
Cancer drug developer OnKure announced it is going public via a reverse merger with Reneo Pharma.
Industry news:
Roche released promising early efficacy data from a GLP-1/GIP agonist it obtained as part of its $2.7 billion purchase of Carmot Therapeutics.
Eli Lilly announced its experimental weekly insulin worked as well as daily insulin products in two late-stage studies.
Neuralink reported an unexpected setback with its first chip implanted in a human skull, acknowledging that the device began detaching from the patient’s brain.
Merck reported negative results from an interim analysis of a Phase 3 study involving the use of its experimental anti-TIGIT antibody/PD-1 combo treatment for advanced melanoma.
The Biden administration raised tariffs on imported medical supplies from China.
The Centers for Disease Control and Prevention will monitor wastewater to track the spread of the H5N1 bird flu virus, due to reluctance among farmers to report outbreaks.
Preliminary data from the CDC’s National Center for Health Statistics showed that drug overdose deaths in the United States ticked down in 2023 – the first decline in five years.
The agency also released federal guidelines to help HCPs address burnout.
Cytokinetics released Phase 3 data on its rare heart disease drug, aficamten, showing it “significantly improved” exercise capacity compared to the placebo.
Sanofi, Pfizer and AstraZeneca separately pledged to increase their respective footprints in France, with investments adding up to almost €2 billion.
Eisai said in a financial guidance that Leqembi could bring in sales of $280 million in the U.S. and $360 million worldwide from Q2 2024 to Q1 2025.
Cardurion Pharmaceuticals presented positive data for its heart failure drug, CRD-740, in patients with heart failure with reduced ejection fraction (HFrEF).
MacroGenics reported that three patients died in a mid-stage trial of its antibody-drug conjugate for prostate cancer.
Autolus Therapeutics delayed its Q1 2024 earnings release and conference call.
Novo Nordisk announced its investigational treatment met both primary endpoints in a Phase 3a study in patients with hemophilia A.
RAPT Therapeutics announced it will terminate two Phase II trials for its lead candidate, zelnecirnon (RPT193).
Dandelion Health launched its GLP-1 data library.
Ionis Pharmaceuticals and Biogen discontinued development of an investigational therapy for amyotrophic lateral sclerosis.
Shionogi’s once-daily COVID-19 antiviral ensitrelvir missed the primary endpoint of a Phase 3 study.
Komodo Health announced a series of updates to its MapEnhance offering.
Walgreens launched its own brand of overdose reversal drug naloxone, which will be available over-the-counter.
