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The patient deaths were deemed unrelated to Vertex’s investigational islet cell therapy, but the study will be halted while regulatory authorities and an independent data monitoring committee review the findings.

The state must submit additional information about the drugs it intends to import before the first shipments are sent to the U.S.

After a topsy-turvy 2023, thousands of industry stakeholders will attend next week’s J.P. Morgan Healthcare Conference in San Francisco to answer a fundamental question: What will this year look like?

The therapeutic targets of many of our top startups are also reflected in recent big biopharma acquisitions and partnerships.

Targeting the red hot antibody-drug conjugate market, OnCusp Therapeutics is coming out of the gate with $100 million from investors such as Novo Holdings and OrbiMed.

In a major pivot, Allogene Therapeutics will no longer focus on two of its studies testing blood cancer therapy cema-cel in an effort to extend its financial runway into 2026.

While initial public offering activity was light in 2023, the new year has recorded the first IPO plan—from California-based CG Oncology.

Eli Lilly on Thursday announced the rollout of a new digital healthcare platform to streamline consumer access to its weight-loss drug Zepbound and other medications.

Once dormant due to a lack of commercial success and drug side effects, the radiopharmaceutical space is gaining momentum in the form of increased investment and scientific advances.

With recent scientific advances, milestone approvals and increased dealmaking, the future of treatment for neurological diseases looks brighter—but continued investment, collaboration and patient-focused efforts are key.

Under the deal disclosed Thursday in an SEC filing, bluebird bio doubled the number of covered U.S. patients for its sickle cell gene therapy to a cumulative total of around 200 million people.

The two agreements announced Thursday will allow AbbVie to leverage Umoja Biopharma’s VivoVec delivery platform, which enables patients’ cells to produce their own cancer-fighting CAR-T cells.

• 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