Business
Novo took the biggest stock price hit of all the drug makers with products subject to Medicare price negotiations in 2027 under the IRA, but at least 11 of its peers on the list will be subject to generic competition between 2025 and 2027.
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
From continuing consolidation on the home market, big pharma appetite to double down on capability centers and notable R&D advances including traction by a second CAR-T cell therapy, the Indian market looks set for an eventful 2025. Scrip spoke to a cross-section of experts to encapsulate some of the key trends in the first instalment of this two-part roundup.
Low on cash when Pfizer handed back rights to its hemophilia A gene therapy, Sangamo is talking to partners for its Fabry disease gene therapy to fund its two lead programs through proof-of-concept.
Daily notebook from the J.P. Morgan Healthcare Conference: Insights from interviews with Astellas, Ultragenyx, Acadia and Tris Pharma; plus updates from Madrigal, Agios and Verve.
Plus deals involving Simcere/AbbVie, Daiichi Sankyo/Glycotope, Telix/ImaginAb, Harbour/Kelun/Windward, Insilico/Menarini, Samsung Bioepis/Teva, HealZen/J&J, Zai Lab/Vertex, Zai Lab/MediLink and Primrose/Serum Institute of India.
At J.P. Morgan, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA commissioner Gottlieb warned of threats to public safety.
The FDA has approved the IL-23 inhibitor for Crohn's disease to add to its ulcerative colitis approval and put the drug in a position to compete with the likes of AbbVie's Skyrizi and Johnson & Johnson's Stelara.
Initial excitement over a few small deals announced at the opening of J.P. Morgan tapered off as approaching exclusivity losses, a lack of big takeouts and political uncertainty weighed on sentiment.
Daily notebook from the J.P. Morgan Healthcare Conference: Gilead's getting more selective; new Roche BD head explains strategy; Bayer's optimistic about elinzanetant launch; AbbVie looks to expand in oncology; and Edgewise, Scholar Rock and Ionis talk 2025 plans.
Plus deals involving Lantheus/Life Molecular Imaging, Teva/Klinge/Formycon, X4/Norgine, Biohaven/Merus, Lilly/Mediar and more.
On the back of a stellar showing in Phase III, apitegromab is going to be filed in the US and Europe in the coming weeks for spinal muscular atrophy and CEO Jay Backstrom believes it will be a $2bn blockbuster.
More than 30 biopharma executives, investors and industry experts shared their views on the environment for funding and deal-making in the year to come. With a patent cliff looming over big pharma at the same time as technology opens manifold possibilities for new approaches to drug discovery and development, the general view is that 2025 will be a busy year for partnering, with a trend towards earlier-stage deals and milestone-dependent payments.
Daily notebook from the J.P. Morgan Healthcare conference: Novartis says Kisqali will be its biggest drug yet; BMS reports strong launch for Cobenfy; Sarepta talks plans for building on Elevidys's success; Lilly updates guidance as tirzepatide slips; and GSK's Miels worked overtime on IDRx.
The chief exec said Moderna plans to work with the incoming Trump administration, but implied hope that US regulatory agencies would heed the scientific consensus on vaccines and focus on risk-benefit.
The US biotech’s Duchenne muscular dystrophy drug is “undoubtedly the most successful gene therapy launch in all of history,” according to CEO Doug Ingram. “We have barely scratched the surface of the opportunity in front of us.”
Daily notebook from the J.P. Morgan Healthcare Conference: J&J's Duato talks about Intra-Cellular deal; GSK's Wood explains how IDRx fits its BD strategy; and Senator Burr says industry needs to look at the long term.
Scrip spoke with Lilly chief medical officer David Hyman at J.P. Morgan about the company’s oncology dealmaking strategy and plans for Scorpion’s selective PI3Kα-targeting asset.
Johnson & Johnson started the M&A year with a bang at the J.P. Morgan meeting, unveiling its $14.6bn bid for Intra-Cellular. The deal would bolster its neuroscience portfolio and pipeline.
The US biotech is paying $250m upfront to the Danish group in what is the second STAT6 deal secured in the past three weeks.