Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
The Belgian drugmaker is boosting its biologics capacity over the pond.
After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.
Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.
The oral BTK inhibitor impresses in a Phase II trial for IgG4-related disease.
Will Zydus’s acquisition and licensing deal with Agenus turn out to be a strategic move towards building an oncology portfolio or an opportunistic one driven by a venture capital mindset?
The company has established the efficacy of its biologic Saphenlo in systemic lupus erythematosus but is now investing across modalities to stay ahead of rivals.
The first Phase III data for the CD38-targeting antibody is expected in 2027 in antibody-mediated rejection in kidney transplant patients, followed by other indications.
The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.
Merck and Lilly are among the leading pharma players using space-based research to power drug development. From reusable satellites to process drugs in low earth orbit to biomanufacturing labs experts discuss R&D opportunities in the starry canvas above.
Series B cash will be used to advance its Stargardt disease gene therapy.
PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.
Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.
Data from the BROADWAY trial testing LDL-C reduction in adults with ASCVD showed that obicetrapib improved Alzheimer’s disease biomarkers, including tau and amyloid. Analysts think the data could differentiate obicetrapib against competitors in the cholesterol market.
Merck’s newly approved Enflonsia for RSV is one of the products that was expected to be recommended for use by the CDC advisory committee in June.
The firm has its ‘foot on the gas’ to accelerate development of its FRα-targeting antibody-drug conjugate, Rina-S, but rival Lilly is also moving rapidly into Phase III.
Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.
The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.
The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.