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TOP STORIES
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Corxel will use the fundraising proceeds to advance the oral GLP-1 therapy CX11 through mid-stage development in the U.S., as well as prepare for its Phase III studies.
Growing opposition to vaccines in the U.S., driven by recent government policy changes, makes it difficult to see a return on investment in vaccine development, Moderna CEO Stéphane Bancel said this week.
“I don’t like established science,” ACIP chairperson Kirk Milhoan said in an interview on the Why Should I Trust You? podcast. “Science is what I observe.”
The partnership will allow BMS to advance a T cell–based therapy that is only activated once in the vicinity of a tumor.
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid painkillers, Jefferies analysts suggested.
Pfizer CEO Albert Bourla said that the main thing getting in the way of changing vaccine discussions in the U.S. is the Secretary of Health, Robert F. Kennedy, Jr.
UPCOMING EVENTS
PRESS RELEASES
• Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 • Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program • Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions
• Quarterly revenue up 8% year over year; Annual revenue guidance range remains at $42-$48 million • CDMO fragrance and Saffron projects reach successful milestones; First quarter CDMO revenue grew 135% YoY • VINIA brand customer base grows to 90,000 active users as of the end of April • Two-lens framework enacted in Q1 to optimize performance across CDMO and D2C businesses
Business development appointment is aligned with securing long-term customers for development and manufacturing partnerships
Another major milestone in its continuous global IP strategy, advancing protection of VIVI Cap Smart across international markets Highlights Granted Patent covers the design of VIVI Cap Smart™ across major international, growing market Strengthens the Company’s intellectual property position in one of the world’s largest healthcare and consumer markets Supports commercialization strategy and strategic discussions with appliance manufacturers Design term extends through May 16, 2039 Company enters into financing arrangement to support inventory build for growing portfolio
MARKET RESEARCH REPORTS