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Amgen will offer its lipid-lowering drug Repatha directly to patients for $239 per month, representing a nearly 60% reduction from the current wholesale acquisition cost of $527.70.

A new survey from CRB showed that most manufacturing initiatives in the U.S. made in response to tariffs are coming from Big Pharma companies, while smaller biotechs are left to hope “the situation doesn’t get worse.”

The inaugural 40 Under 40 cohort includes CEOs, leaders who have founded or co-founded their company and executives from a range of disciplines. Winners’ accomplishments include shaping drug development, achieving key FDA milestones and launching a new field of study.

Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.

A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components of the MMRV shot due to concerns over febrile seizures, while recommending a more risk-based approach to COVID-19 immunizations that mirrors recent FDA approvals.

The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ‘strain’ on its capacity, according to Neurizon.

AstraZeneca has invested heavily in AI, primarily through collaborations, including an up to $5.3 billion partnership with China’s CSPC Pharmaceutical in June.

This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.

Rocket Pharmaceuticals’ strategic realignment initiative in July pulled funding from fanca-cel, which the biotech was developing for Fanconi anemia.

The centerpiece of the collaboration is the gene editor ABO-101, being developed for primary hyperoxaluria type 1, a rare disease that leads to severe kidney stones.

As industry leaders gather at the annual event in Phoenix, the cell and gene therapy space remains in a state of flux, with M&A activity and regulatory support signaling momentum while commercialization challenges continue to hinder broader investor interest.

Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.

• 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