| 06.23.25 | Acting CDER head adds to FDA departures; Novo abruptly ends Hims & Hers obesity deal

Click here to subscribe to Fiercebiotech.com

9 hours ago

Html
Text

PM Tracker

Webinar: Optimizing the Path from Discovery Chemistry to Development

Thursday, July 10, 2025 | 10am ET / 7am PT

The transition from drug discovery to process development poses significant challenges. Join us for this deep dive into how adopting a collaborative approach between medicinal and process chemistry teams can help address key obstacles and accelerate progress from discovery to early clinical milestones. Register now.

Today’s Big News

Jun 23, 2025

FDA's acting CDER head Corrigan-Curay heads for the exit amid period of heavy turnover: reports

Hims & Hers stock plunges 30% as Novo Nordisk terminates Wegovy direct sales deal

BrightGene tops Novo drug in diabetes ahead of Zepbound showdown

Lilly eyes global approval filings as once-weekly insulin candidate takes clinical victory lap

Diabetes and obesity boom will propel Lilly, Novo to front of pharma sales pack by 2030: Evaluate

Sanofi signs €545M deal to explore Formation’s JAK/SYK inhibitor in new indication

Compass points to psychedelic therapy's phase 3 depression win, but investors unimpressed

Illumina picks up proteomics developer SomaLogic from Standard BioTools for $425M

Webinar: Fueling REMS Program Success via Service and Technology

Thursday, July 22, 2025 | 10am ET / 7am PT

Join us to take an exciting look at the forefront of REMS transformation. Learn how leading technology, integrated strategies and operational excellence are redefining what’s possible. Gain the insights you need to reduce complexity, enhance compliance and deliver more value across the REMS lifecycle. Register now.

Featured

FDA's acting CDER head Jacqueline Corrigan-Curay heads for the exit amid period of heavy turnover: reports

By Eric Sagonowsky

Only a few days after reports emerged that the director of the FDA's cell and gene therapy office had been abruptly put on administrative leave, a new departure shows that an intense period of leadership turnover at the agency isn't over.

Hims & Hers stock plunges 30% as Novo Nordisk terminates Wegovy direct sales deal

By Heather Landi

Hims & Hers stock plunged around 30% on Monday after drugmaker Novo Nordisk abruptly ended a month-long collaboration to make its weight loss drug Wegovy available on the telehealth company's platform.

BrightGene tops Novo drug in diabetes ahead of Zepbound showdown

By Nick Paul Taylor

BrightGene Pharmaceutical has scored an early win in its push to topple the big beasts of the GLP-1 field. The biotech linked its challenger to bigger reductions in blood sugar than Novo Nordisk’s semaglutide, giving momentum as it barrels toward a readout from a head-to-head trial against Eli Lilly’s tirzepatide.

Lilly eyes global approval filings as once-weekly insulin candidate takes clinical victory lap

By Fraiser Kansteiner

Lilly provided a comprehensive look at positive results from a group of studies that assessed the company's once-a-week insulin candidate efsitora in multiple Type 2 diabetes patient populations. Lilly says it plans to submit its efsitora package to global regulators by the end of the year.

Whitepaper: Using Client Centricity as Fuel for Innovative Biologics Development and Manufacturing Solutions

The biologics development and manufacturing sector has long been at the forefront of innovation, consistently driving therapeutic advancements for a wide array of complex diseases. While demand has never been greater, there are still many technical challenges. This valuable resource uncovers how to navigate today’s top obstacles. Download now.

Diabetes and obesity boom will propel Lilly, Novo to front of pharma sales pack by 2030: Evaluate

By Kevin Dunleavy

Fueled by sales of its diabetes and obesity products, Eli Lilly will become the world’s top-seller of prescription drugs by 2030 and will hold the top rung by a wide margin, according to data analytics specialist Evaluate Pharma in its 2030 projection.

Sanofi signs €545M deal to explore Formation’s JAK/SYK inhibitor in new indication

By James Waldron

Having secured one of last year’s largest funding rounds, AI-focused Formation Bio is now eyeing up to 545 million euros ($626 million) from a licensing deal with Sanofi.

Compass points to psychedelic therapy's phase 3 depression win, but investors unimpressed

By James Waldron

Compass Pathways' delayed phase 3 readout for its psilocybin treatment has hit its primary endpoint of reducing the severity of patients’ depression, but investors appear unimpressed.

Illumina picks up proteomics developer SomaLogic from Standard BioTools for $425M

By Conor Hale

Illumina is diving deeper into proteomics research with a $425 million plan to acquire SomaLogic, including its protein analysis platforms and certified lab services business.

AstraZeneca faces new allegations over trial data for blood thinner Brilinta: BMJ

By Kevin Dunleavy

Fourteen years after AstraZeneca’s blood thinner Brilinta reached the market and now faces generic competition, the data that backed its original approvals around the world has been called into question.

Leap expands layoffs to cover 75% of employees, scraps only clinical trial to save cash

By James Waldron

Leap Therapeutics is expanding its layoff plans to encompass three-quarters of its staff while scrapping its sole clinical trial.

Reckitt recruits Serena Williams for initiative to support 200 women-led health startups by 2030

By Andrea Park

Reckitt has selected Serena Williams as its doubles partner for a new plan to serve up support for health and hygiene startups around the world.

J&J launches daily disposable contact lens for astigmatism, presbyopia

By Conor Hale

J&J said people with astigmatism have had to compromise when presbyopia develops—either by switching to reusable lenses or adding on reading glasses.

Fierce podcasts

Don’t miss an episode

AbbVie, ADCs and the future of cancer care

This week on "The Top Line," AbbVie’s Daejin Abidoye, M.D., joins us to discuss the future of antibody drug conjugates.

Inside Fierce Medtech's Fierce 15

A bold bet on sharing real-time patient data

Real World Evidence Expedites Drug Development

QPS leverages a combination of clinical and regulatory expertise, exceptional data scientists, and AI to deliver RWE studies that support accelerated drug development for biotech clients. Learn More.