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The regulator is launching an investigation of Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound and other GLP-1 receptor agonists following patient reports of suicidal ideation, alopecia and aspiration.

In the third deal in as many days, Roche is paying $66 million upfront to MOMA Therapeutics to find new drugs to go after cancer cell growth, with a potential $2 billion total in milestones and royalties.

Wednesday’s settlement resolves a legal dispute between Daiichi Sankyo Europe and Esperion Therapeutics regarding milestone payments under their cardiovascular drug collaboration.

The late-stage pharmacokinetic study was stopped early due to efficacy at interim analysis, Lyndra Therapeutics said Thursday. A six-month safety study will start in the second half of 2024.

BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation discuss alternative financing strategies to consider for 2024. Listen now.

Novo Nordisk’s partnerships with Flagship Pioneering-backed Omega and Cellarity, each worth up to $532 million, will explore novel treatment approaches to obesity and metabolic dysfunction-associated steatohepatitis.

With a PDUFA date in the second quarter of 2024, Pfizer is poised to compete with CSL Behring, whose Hemgenix became the first FDA-approved gene therapy for hemophilia B in November 2022.

The pharmacy benefit management subsidiary of CVS Health is favoring Humira’s biosimilars for its major formularies, with AbbVie’s branded product to be nixed on April 1, 2024.

The Interface Biosciences co-founder said forging the relationships needed to launch a startup can be a challenge for members of underrepresented groups, making confidence and adaptability key.

Rapport Therapeutics tops this year’s list with $250 million in Series A and B financing in just six months.

While GLP-1 drugs have exploded in popularity, they don’t work for everyone, and experts say phenotyping based on a greater understanding of the disease is the future of obesity treatment.

Tome Biosciences has only been on the scene for a short time but on Tuesday notched an acquisition of CRISPR-based biotech Replace Therapeutics for $65 million upfront.

• 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