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Aside from lowering triglyceride levels, Ionis’ olezarsen reduced acute pancreatitis events, an outcome that BMO Capital Markets said could help the asset deliver a “significant first-in-class commercial launch.”
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The largest Chinese licensing deal behind Pfizer’s is Novartis’ partnership with Shanghai Argo Biopharma, worth potentially more than $4 billion.
The Most Favored Nation order is unlikely to deliver broad, sustained savings without triggering legal challenges, administrative friction and unintended consequences for both the healthcare sector and patient access.
FDA
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the concerns and opportunities of patient data driving AI tasks with Louise Molloy, associate director medical information and pharmacovigilance.
Rinvoq’s efficacy in alopecia areata is “impressive,” according to Guggenheim analysts, who said the drug could have a competitive edge over other JAK inhibitors in the space.
Long-term extension data presented at the Alzheimer’s Association International Conference showed amyloid plaque reaccumulation remained slow at up to 2.5 years of follow-up in patients who were taken off of treatment with Eli Lilly’s anti-amyloid antibody.
Looking for a biopharma job in North Carolina? Check out the BioSpace list of seven companies hiring life sciences professionals like you.
A new report found that 85% of pharma respondents are increasing their artificial intelligence investments, and 70% see AI as an immediate priority. Two experts discuss how biopharmas are implementing and adopting AI, including their increased use of external help with the process.
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a second FDA division to his portfolio after Vinay Prasad’s sudden departure.
FDA
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more were top of mind.
Madrigal will study SYH2086 in combination with Rezdiffra for metabolic dysfunction-associated steatohepatitis, aiming for clinical trials in early 2026.
Long-term data presented at the Alzheimer’s Association International Conference show Leqembi can help patients stay in the earlier stages of Alzheimer’s disease as compared to the condition’s natural progression.
CDC
Monarez is the first CDC director to be confirmed by the Senate under a new 2023 law and will be the first person without a medical degree to assume leadership of the agency in more than 70 years.