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J&J reports today, just two weeks after Pfizer secured certainty on tariffs and drug pricing. Analysts expect to hear about plans from the rest of the industry during third period earnings calls.

Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.

Nabla and Takeda first joined hands in 2022, to push “the boundaries of next-generation biologics discovery,” according to the startup’s CEO Surge Biswas.

While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams.

Regeneron is aiming to file a regulatory application for DB-OTO by the end of the year.

The last few months have been tumultuous for the CDC, which has seen the ouster of Director Susan Monarez and all 17 members of the Advisory Committee on Immunization Practices.

Moderna’s mRNA-4359, when used with Keytruda, achieves a 24% overall objective response rate in patients with melanoma, with efficacy increasing to 67% in those positive for PD-L1.

Novo had around 250 employees working on cell therapies, all of whom will be laid off, though a spokesperson declined to reveal which offices and locations will be affected.

The market outlook is full of uncertainty and pitfalls. Experts weigh in on how to mitigate risks.

While the benefits of AI are clear, the amount data sets needed for effective AI integration is proving to be a challenge. This is particularly true for cell therapy companies as they are eagerly seeking ways to reduce development costs. Two experts at Charles River Laboratories provide insights by giving their takeaways from their own AI integrations.

To drive true innovation in drug development, executives must not let excitement about the latest shiny object obscure ultimate outcomes.

Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.

• 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