MSD, Eisai report setback in first-line kidney cancer trial
Pharmaphorum
The LITESPARK-012 trial saw no benefit when Welireg was added to treatment with Keytruda plus Lenvima for renal cell carcinoma.
Gilead, Arcus tumble again in TIGIT, triggering 2 trial culls
BioSpace
The Phase 3 failure has prompted Gilead Sciences and Arcus Biosciences to terminate a mid-stage study of their TIGIT asset in lung cancer.
Jazz and Lilly cancer drugs cleared for use by NHS
Pharmaphorum
Jazz’s biliary tract cancer drug Ziihera and Lilly’s Jaypirca for chronic lymphocytic leukaemia have been backed for NHS use in new NICE guidance.
Serif, Flagship’s latest biotech, aims to make a new kind of genetic medicine
BioPharma Dive
The startup is developing modified DNA therapies it claims can combine the strengths of multiple approaches, from messenger RNA to gene therapy.
FDA kicks off review of Roche’s Gazyva for wider lupus use
Pharmaphorum
Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus.
Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy
Pharmaceutical Business Review
The application aims to allow the use of this combination therapy for all patients with MIBC, regardless of their cisplatin eligibility.
Eli Lilly doubles down on in vivo with $7bn Kelonia buyout
Pharmaceutical Technology
Lilly now has a lentiviral and LNP-based platform for in vivo delivery under its belt, which could broaden the company’s chance of success.
Asahi Kasei acquires German company Aicuris
Pharmaceutical Business Review
The move comes after Asahi Kasei signed a definitive agreement to acquire all issued shares of Aicuris for approximately 780m ($920.7m) earlier this year.
Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy
Pharmaceutical Technology
Pfizer and Astellas have received FDA acceptance for priority review of their sBLA for perioperative Padcev combined with Keytruda for MIBC.
Italy leads the way on child genetic disease diagnosis
Pharmaphorum
A scheme to hasten the diagnosis of children with genetic disorders is achieving strong results and could be a template for national health systems.
Asahi Kasei acquires German company Aicuris
Pharmaceutical Technology
Asahi Kasei has completed its acquisition of Aicuris Anti-infective Cures, a German biopharmaceutical company.
Trump executive order lifts psychedelics biotechs
BioPharma Dive
Meant to speed research and access to psychedelics for mental health conditions, the order is the latest in a series of developments that, to Wall Street, make psychedelics a more investable space.
RFK Jr. defends HHS tenure, 12% proposed budget cut
BioPharma Dive
Republicans largely praised the HHS secretary s track record during a marathon of House hearings last week, but some raised concerns about proposed budget cuts to the National Institutes of Health.
Nektar surges again as alopecia drug shows new promise in extension study
BioPharma Dive
Patients who’d seen substantial hair regrowth in the first part of Nektar s trial had a deepening treatment response, extending a comeback bid that s caused shares to skyrocket over the last year.
Lilly boosts ‘in vivo’ cell therapy capabilities with Kelonia buyout
BioPharma Dive
Worth up to $7 billion, Lilly s second recent acquisition of a company in the space is centered around a cell therapy that s currently in early-stage testing for multiple myeloma.
FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
FDA
Since publishing roadmap last April, agency has successfully launched several key initiatives to replace animal testing with better alternatives
221: An Interview With Dutch Neurologist Ewout Groen of SMA Europe
Rare Disease Audio
Larry Luxner, senior correspondent for Rare Disease Advisor, interviews Dutch neurologist Ewout Groen, PhD, a member of the Scientific Advisory Board of SMA Europe.
AACR 2026: Revolution’s next prospect, Merck’s reveal and a lung cancer battle
BioPharma Dive
Featured at this year s meeting on early cancer research were results from an immunotherapy Merck acquired in 2024 and several targeted medicines for lung tumors.
Boehringer Ingelheim launches AI centre in London
Pharmaceutical Technology
The new site will focus on the use of AI models for purposes including the discovery and development of targeted medicines for patients with unmet medical needs.