Drug Development

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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
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.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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A post hoc analysis of data from the Phase II CENTAUR study showed a 10.6-month longer median survival duration for AMX0035 participants, Amylyx announced Thursday.
Novartis announced on Thursday that it will be temporarily and voluntarily suspending the production of its cancer therapeutics Lutathera and Pluvicto at facilities in Italy and New Jersey.
Researchers at the University of Illinois at Chicago have uncovered the possibility of utilizing gene editing to reverse a cause of anxiety and alcohol use disorder (AUD).
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.
Intellia’s first-quarter financial conference call and report focused on the ongoing Phase I trial of NTLA-2001 in transthyretin (ATTR) amyloidosis with polyneuropathy patients.
Two biologic therapeutic candidates have met their primary endpoints in phase III trials, including AstraZeneca’s Champion-NMOSD trial and Argenx’s Advance trial.
AstraZeneca’s proposed treatment for heart disease delivered positive high-level results from its Phase III DELIVER trial of Farxiga. Here’s more about this drug.
The FDA’s reaction came after Pfizer CEO Albert Bourla said that physicians may give a second five-day course of Paxlovid if patients see a spike in their SARS-CoV-2 viral load.
After the market closed on Wednesday, Allogene reported its first-quarter financial results, along with updates to its research programs. The report marked Allogene’s fourth anniversary.
Jazz’s Q1 included a key licensing deal with Werewolf Therapeutics and another announced Wednesday with Japan’s Sumitomo Pharma Co. for a narcolepsy treatment.