The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.
The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.
The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares
The Texas-based firm is giving up on the investigational Alzheimer’s therapy after a second Phase III failure left it with nowhere to go in the disease.
A decision from the FDA is due by 28 September.
A new “quasi-experimental” study using UK National Health Service data might confirm that GSK’s shingles vaccine helps cut dementia cases.
Heads of Novartis Biomedical, World Economic Forum and Indian majors like Sun Pharma’s SPARC, among others, discuss generative AI in drug discovery along with pointers for India to leapfrog the R&D process
Projected return on investment for the 20 pharmas with the highest R&D spend is expected to rise for the second straight year, Deloitte says. How to get there is less clear.
The obesity market leader is teaming up with China’s United Bio-Technology to develop a product they believe could beat Lilly’s late-stage same-class candidate retatrutide.
Obefazimod has been heralded as a potential blockbuster for ulcerative colitis and there will be great interest in the readout of Phase III induction trials in the third quarter of this year.
The Belgian firm banks nearly €77.7m to push its Charcot-Marie-Tooth to proof-of-concept.
Professor Anil Koul shares vignettes of his life and career trajectory, a captivating mix of hope, science and destiny that took him to the lab of eminent cancer biologist Alex Ullrich at the Max Planck Institute and also saw him contribute to the development of breakthrough TB drug bedaquiline. He also talks about Medicine 3.0 and the intersection of science and spirituality.
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.
Encouraging results in younger children with Duchenne is keeping Regenxbio on track for a potential mid-2026 filing for its gene therapy, RGX-202.
The France-based giant inks a transaction potentially worth around $1.9bn to get hold of Dren Bio’s autoimmune disease treatment DR-0201.
The company’s Immunovant announced positive data from a Phase III trial in myasthenia gravis but the focus is on next-generation drug IMVT-1402.
The 75-year-old veteran of rare disease drug development is handing over the reins to a successor, but will stay to help Stoke Therapeutics expand its pipeline.
CEO Carlos Gallardo tells Scrip the Barcelona-based group has laid the foundations to advance four promising assets that have considerable potential for a variety of dermatological diseases.