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China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
Sales of Johnson & Johnson’s esketamine-based nasal spray jumped in the fourth quarter last year, priming the pump for a suite of other pharmas, including AbbVie, champing at the bit with their own psychedelics.
With Biogen’s multiple sclerosis portfolio facing more generic pressure than ever, the company is eyeing a busy late-stage pipeline and hunting for deals to build its return to growth.
According to Priovant, the Phase 2 BEACON study is the first industry-sponsored placebo-controlled trial in cutaneous sarcoidosis to deliver positive data.
Novo Nordisk has also spoken out strongly against Hims & Hers’ compounded Wegovy pill, with CEO Maziar Mike Doustdar telling investors the knockoff version is a waste of money.
Biopharma’s obsession with the weight loss sector—projected to exceed $130 billion in revenue by 2035—shows no signs of slowing down as analysts gear up for a year that will test the oral market and provide key data on novel mechanisms.
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
Bristol Myers Squibb delivered better than expected fourth quarter earnings, but Eliquis missed expectations while Cobenfy continues to struggle with uptake.
Despite the Phase 1 cull, CEO Vas Narasimhan on Wednesday maintained that Novartis continues to invest in its early-stage pipeline, looking for deals in the “sub-$2-billion range.”