ASCO 2024 commentary: data and therapeutic standouts (PharmaLive)
While the science at ASCO continued to push the boundaries for cancer care, much of the conversation in the hallways revolved around the ever-increasing challenges on translating trial successes into clinical practice.
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US FDA panel votes against first MDMA-based PTSD treatment (Reuters)
Advisers to the U.S. Food and Drug Administration on Tuesday voted against a therapy based on the mind-altering drug MDMA for patients with post-traumatic stress disorder, marking a setback to the nascent field of psychedelic treatments.
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Lilly’s Zepbound wins NICE backing for obese patients with very high BMI (BioSpace)
Tuesday’s NICE recommendation for Zepbound comes after the agency in late 2023 also backed the use of its sister tirzepatide brand Mounjaro for type 2 diabetes.
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Accelerated approval therapies reach diverse range of Medicare beneficiaries (PharmaLive)
Accelerated approval allows the FDA to rely on surrogate or intermediate clinical endpoints to approve therapies in a shorter time frame than would be possible with traditional endpoints, but it has come under scrutiny by some policymakers and researchers in recent years.
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Companies to watch for potential M&As in 2024 (BioSpace)
This year has seen a boom in biopharma mergers and acquisitions, with six acquisitions over a billion dollars so far. In light of the massive revenues pharma companies are generating in the obesity space and the pressure many companies are under from looming loss of exclusivity on top drugs, analysts don’t see it slowing down anytime soon.
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Amgen's drug meets main goal in late-stage study for rare disease (Reuters)
The drug was being studied for the treatment of Immunoglobulin G4-related disease, which is characterized by periods of remission and unpredictable disease flares.
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Viking builds case for NASH hopeful with histological data (BioSpace)
Viking Therapeutics’ nonalcoholic steatohepatitis candidate VK2809 significantly improved secondary histologic endpoints at 52 weeks with no worsening of fibrosis, as assessed by hepatic biopsy.
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