Business
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.
Plus deals involving Relmada/Trigone, Alvotech/Xbrane, OPKO Health/Entera, iOncologi/TargImmune and more.
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
Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.
Merck & Co., which already has an oral PCSK9 inhibitor in Phase III, licensed Hengrui’s Lipoprotein(a)-lowering small molecule HRS-5346 outside of Greater China for $200m up front.
A decision from the FDA is due by 28 September.
The promise of innovative therapies seems to have been constrained not by efficacy or safety concerns, but because the high price of treatments is incongruous with the reimbursement of short-course therapies.
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
Lilly’s Mounjaro arrives in India, with the 2.5mg vial priced at under $41 in a market that has over 100 million diabetics and increasing obesity rates. Will the product see sharp demand like in China, carving out a chunk of the pie ahead of the potential arrival of semaglutide generics and could there be concerns of ‘suitcase' exports?
South Korea's LigaChem is kickstarting a growth and globalization drive through a potential future acquisition of UK ADC player IKSUDA.
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 founder and CEO of Ultragenyx talked with Scrip as the company approaches a pivotal data readout and awaits US FDA action on its first gene therapy.
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.
In this week's episode: Pfizer tops pharma leaderboard; AstraZeneca buys into in vivo cell therapy; Almirall looks to dominate derma spectrum; Incyte’s HS contender looks approvable; and MSD’s Williams says pharma should shorten tech adoption cycles.
UK pharma will invest $2.5bn in Beijing R&D hub, build a vaccine manufacturing site with BioKangtai, and partner in chronic disease with Syneron and in oncology/immunology with Harbour BioMed.
J&J followed in the footsteps of Lilly and Merck, which have announced multibillion-dollar investments in US manufacturing since Donald Trump’s inauguration.
The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.