Deals:
AstraZenecaannounced plans to acquire Fusion Pharmaceuticals for up to $2.4 billion.
Lonza announced it would buy one of the world’s largest manufacturing sites for biologic drugs from Roche for $1.2 billion.
VML Health and Definitive Healthcare partnered to launch a key opinion leader management platform.
Healthcare technology company Syllable acquired Actium Health.
Commercial-stage biopharma Bio-Thera Solutions partnered with SteinCares on a licensing agreement for two biosimilars under which SteinCares will have exclusive rights to distribute and market Bio-Thera’s pharmaceuticals in Brazil and Latin America.
Insights management firm Within3 announced a strategic partnership withcontent engagement manager for life science events Array.
Sosei Heptares regained full ownership of HTL0027477, an oral GPR35 agonist for inflammatory bowel disease, from GSK.
Bayer and Thermo Fisher Scientific are collaborating to develop next-generation sequencing-based companion diagnostic assays.
FDA:
The agency approved Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), a gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy.
Takeda Pharmaceuticals’ cancer drug Iclusig received an accelerated approval in combination with chemotherapy from the FDA for newly-diagnosed adults with Philadelphia chromosome-positive acute lymphoblastic leukemia.
An agency adcomm recommended Johnson & Johnson‘s Carvykti to treat relapsed or refractory multiple myeloma.
The FDA accepted the resubmission of the Citius Pharmaceuticals’ Biologics License Application for Lymphir (denileukin diftitox).
The agency approved a treatment from Idorsia for patients with resistant hypertension.
PTC Therapeutics submitted a BLA to the FDA for Upstaza (eladocagene exuparvovec).
Layoffs:
CureVac announced 150 employees have agreed to a voluntary exit amid a cost-cutting process.
Siemens Healthineers closed its fast track testing arm.
Funding rounds:
Madrigal Pharmaceuticals announced plans to raise $600 million in an offering to support its recently-approved NASH drug Rezdiffra.
Mirador Therapeutics launched with a $400 million Series A funding round.
Spyre Therapeutics announced a $180 million private placement.
Bluebird Bio inked a five-year, term loan deal with Hercules Capital, providing it with up to $175 million in debt financing.
Clasp Therapeutics raised $150 million in a round led by Catalio Capital Management, Third Rock Ventures and Novo Holdings.
Clinical-stage biopharma Fate Therapeutics priced $100 million in underwritten offering and concurrent private placement.
PureTech Health offered to return $100 million to its shareholders through a tender offer of its shares.
Boundless Bio set its sights on about $88.4 million in net proceeds from its proposed IPO.
Wearable technology company Ultrahuman announced a Series B funding round of $35 million.
Startup Profluent pulled in $35 million in funding and added the former head of product at OpenAI to its board of directors.
Gene therapy biotech Asgard Therapeutics closed a $32.6 million Series A funding round.
Elicio Therapeutics announced a $6 million private placement.
Portal Biotechnologies announced a $5 million pre-seed round led by Pear VC.
Contineum Therapeutics, previously known as Pipeline Therapeutics, has plans to go public.
Industry news:
Chip designer Nvidialaunched two dozen generative AI microservices to drive healthcare innovation.
With an eye on Astellas Pharma’s Veozah, Bayer released promising Phase 3 trial data for its non-hormonal drug candidate for hot flashes in postmenopausal women.
Kenvuelaunched a global creative review.
Pfizer will sell down its stake in Haleon to about 24%.
Joining Boehringer Ingelheim, AstraZeneca capped out-of-pocket inhaler costs at $35.
The precipitous decline in demand for COVID-19 vaccines hampered BioNTech’s financials for yet another quarter.
Bristol Myers Squibb said a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) improved overall survival in a patient population treated with treatments from AstraZeneca and Roche.
The American Medical Association urged individuals to get vaccinated against the measles if not already immune.
Crinetics noted a second Phase 3 trial win for its paltusotine drug candidate treating acromegaly.
President Joe Biden issued an executive order to bolster women’s health research.
AstraZeneca announced strong results from a Phase 3 trial of Lynparza and Imfinzi treating endometrial cancer.
The Environmental Protection Agency announced a comprehensive ban on asbestos.
Merck released positive Phase 3 data on V116, its investigational, 21-Valent pneumococcal conjugate vaccine. However, the companyalso reported the failure of a late-stage study of a combination of Keytruda and Lynparza in the early treatment of certain lung cancer patients.
BillionToOne launched a BabyPeek add-on to its UNITY prenatal test.
The Bill & Melinda Gates Medical Research Institute initiated a Phase 3 clinical trial of its tuberculosis vaccine candidate.
Seelos Therapeutics‘ experimental ALS drug did not meet the main goal of a mid-stage trial.
HMP Global launched HMP Collective, a medical strategy and marketing business unit.
Acelyrin reported positive preliminary results from an early study of its thyroid eye disease antibody treatment.
Johnson & Johnson sued a former employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer.
GSK said Jemperli showed potential in a Phase 3 trial of treating adults with advanced or recurrent endometrial cancer.
Valneva raised its full-year product sales guidance to between €160 million and €180 million.
U.K.-based creative agency TrunkBBI won three new clients: Abbott, the European Society of Cardiology and Hoya.
IGC Pharma released promising results of an interim analysis of its ongoing Phase 2 trial for Alzheimer’s treatment IGC-AD1.
