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TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
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UniQure’s Path for Huntington’s Gene Therapy Clouded by Ethical Questions as Potential Phase 3 Looms
While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be considered for approval, experts believe there is an alternate path forward for the therapy, perhaps even based on precedent from the recent drama surrounding Moderna’s mRNA flu vaccine.
Poplar Therapeutics is seeking a “step change” in the treatment of food allergy and other atopic conditions, with $95 million raised to date, including a $45 million series A extension that closed Tuesday.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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Adam Urato, who is currently a vaccine advisor to the CDC, is closely associated with acting CDER director Tracy Beth Høeg and is a fellow skeptic of the use of selective serotonin reuptake inhibitors during pregnancy.
The timing of the partial hold is “odd,” according to analysts at Stifel, who noted that the preclinical data the FDA took issue with were filed in mid-2024.
South Korea has attracted increasing investment from the pharmaceutical industry, which is drawn to the Asian country due to its experience in antibody-drug conjugates and cell and gene therapies, according to McKinsey.
In this episode of Denatured, you’ll listen to Ram May-Ron, managing partner at FreeMind Group, and Ravi Kiron, managing director at Biopharma Strategy Advisors. We’ll be speaking about how to combine nondilutive funding and family office money into a unified strategy that gets companies through the drug development valley of death.
Having targeted Hims & Hers last year, the FDA has issued warnings to more telehealth companies over their promotion of GLP-1 drugs used to treat diabetes and obesity. In one case, compounded products were linked with multiple ER visits.
UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under probe for allegedly fostering a toxic workplace; Sarepta CEO Doug Ingram is stepping down after several years of tumult at the top of the muscular dystrophy–focused company; and Eli Lilly again tops Novo Nordisk in a weight loss trial.
The funding comes weeks after TL1A blocker duvakitug maintained clinical remission rates above 50% in patients with ulcerative colitis and Crohn’s disease in a Phase 2b trial.
While an anonymous source tied the closure to shortcomings in the FDA’s new pathway, a spokesperson for the Department of Health and Human Services pushed back on the suggestion.
The settlement, which requires Moderna to pay the plaintiffs $950 million upfront plus up to $1.3 billion in contingent commitments, is an outcome “better than feared,” according to analysts.
Sanofi will gain global exclusive rights over rovadicitinib, an oral JAK/ROCK blocker that has anti-inflammatory and anti-fibrotic effects.