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AdComm backs earlier use of CAR-T for multiple myeloma
March 18, 2024
The Oncologic Drugs Advisory Committee voted in favor of expanding the use of J&J and Legend's Carvykti and Bristol Myers Squibb and 2seventy bio's Abecma
Novartis announces Singapore site expansion
March 18, 2024
The $256 million expanded facility, with a focus on therapeutic antibody drugs, is expected to be operational by early 2026
FDA approves BeiGene esophageal cancer drug
March 15, 2024
The nod marks the first U.S. indication for Tevimbra, expected to be available in the latter half of 2024
Madrigal wins first FDA nod for NASH
March 14, 2024
Rezdiffra becomes the first and only treatment for the severe form of fatty liver disease
BIO backs BIOSECURE Act, boots WuXi
March 14, 2024
The industry's largest biotech trade association is removing WuXi AppTec from its membership roster
AstraZeneca to acquire Amolyt Pharma
March 14, 2024
The potential $1.05 billion deal will boost AstraZeneca's rare disease portfolio
Amazon Pharmacy to deliver Eli Lilly drugs
March 13, 2024
The partnership will facilitate access to specific prescriptions for obesity, diabetes, and migraines through a direct sales platform
Novartis buys IFM unit, picking up STING inhibitors
March 13, 2024
In a deal that could reach $835 million, Novartis will pick up a portfolio of STING antagonists targeting serious inflammation-driven diseases
Merck, Pearl Bio ink programmable biologics partnership
March 12, 2024
The potential $1 billion deal will pave the road for new classes of multi-functionalized biologics with tunable properties
Acadia abandons plans to expand pimavanserin indications
March 12, 2024
The drugmaker has halted efforts to expand the label on its lead drug following a phase 3 trial flop in schizophrenia
Boehringer, Sosei Heptares partner on schizophrenia treatments
March 11, 2024
In the deal, which could exceed $760 million, Boehringer has the exclusive option to license Sosei's GPR52 agonists
Incyte JAK1 inhibitor shines in phase 2 trial
March 11, 2024
The drug significantly improved itch relief across various dosage groups compared to placebo
Amylyx ALS drug falls short in phase 3 trial
March 8, 2024
The company is contemplating a potential market withdrawal, pending discussions with regulatory bodies
FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm
March 8, 2024
The agency will convene an unexpected advisory panel meeting to dig deeper into the safety and efficacy of donanemab
Boehringer Ingelheim to cap out-of-pocket inhaler prices
March 7, 2024
Eligible patients will pay $35 per month for its entire range of inhaler medications for COPD and asthma
Gilead bets on Merus trispecifc T-cell engagers
March 7, 2024
In a deal that could exceed $1.5 billion, Gilead will have the option to license novel trispecific therapeutics
Sandoz wins first FDA nod for bone drug biosims
March 6, 2024
Wyost and Jubbonti are the first approved biosimilars to Amgen's denosumab blockbusters, Xgeva and Prolia
BiomX acquires Adaptive Phage Therapeutics
March 6, 2024
The merger boasts two key phase 2 projects: BX004 for cystic fibrosis-related infections, and BX211 for diabetic foot osteomyelitis
Perrigo launches OTC birth control pill nationwide
March 5, 2024
The move follows the FDA’s landmark approval in July 2023, allowing Opill to be sold without a prescription for users of all ages
Telix to buy radioisotope tech company ARTMS
March 5, 2024
The Australian biotech inks another deal as it firms up its diagnostic isotopes supply chain
FDA approves J&J combo therapy for lung cancer
March 4, 2024
Rybrevant, in combination with chemotherapy, was granted full approval as a first-line treatment for specific NSCLC mutations
Bayer buys European rights to BridgeBio heart drug
March 4, 2024
Bayer will pay $310 million upfront to commercialize the potential heart disease blockbuster in Europe
Gritstone reduces workforce by 40%
March 1, 2024
The cuts come as the company's BARDA-funded vaccine trial is delayed until the fall
Endo reaches $1.5B opioid settlement
March 1, 2024
The settlement includes a criminal plea, where Endo will plead guilty to misbranding drugs
Ionis announces leadership change
Feb. 29, 2024
Kyle Jenne returns to Ionis to lead its commercialization efforts
Iovance Amtagvi U.S. launch underway
Feb. 29, 2024
Less than two weeks after winning a historic FDA approval, Iovance says 20 patients have already begun treatment
AstraZeneca, Fibrogen end anemia drug partnership
Feb. 28, 2024
After a turbulent journey marked by data manipulation and FDA rejection, AZ has returned all rights for roxadustat
FDA rejects Theratechnologies sBLA for intramuscular HIV drug
Feb. 28, 2024
The Montreal-based company was hoping to further simplify its Trogarzo treatment regimen, but the FDA was not convinced
Novo Nordisk, Neomorph ink $1.46B molecular glue deal
Feb. 27, 2024
Neomorph will lead early-stage research and receive payments and funding, while Novo Nordisk gets exclusive rights for later development and sales
BioMarin hit with DOJ subpoena for sponsored testing programs
Feb. 27, 2024
The U.S. Department of Justice is seeking information about the company's programs related to two older treatments
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