Industry News

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