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Jan 27, 2025

Top 10 most anticipated drug launches of 2025

FDA’s diagnostics CMO named interim agency commissioner

Pfizer avoids board nominations from Starboard as proxy fight rolls on: Bloomberg

Cell therapy biotech Aurion eyes IPO despite legal pushback from investor

No deal: Sage rejects Biogen's buyout offer, scouts for strategic alternatives

Gearing up to challenge Lilly in obesity, Kailera picks Zepbound brand leader as new commercial chief

Akero's stock doubles as midphase MASH trial generates 'transformational' data: analyst

Featured

Top 10 most anticipated drug launches of 2025

By Andrea Park,Nick Paul Taylor

According to Evaluate’s forecasts, the biggest potential drug launches of the coming year stand to generate a collective $29 billion in annual sales by the end of the decade, nearly double the estimate for last year’s top 10.

FDA’s diagnostics CMO named interim agency commissioner

By Conor Hale

The FDA has tapped Sara Brenner to serve as acting commissioner as it awaits new leadership from the Trump administration to complete the congressional confirmation process.

Pfizer avoids board nominations from Starboard as proxy fight rolls on: Bloomberg

By Fraiser Kansteiner

Activist Investor Starboard Value stopped short of nominating any directors to Pfizer’s board ahead of a Jan. 25 deadline, Bloomberg reported Monday. A Starboard-backed director—or two—would have given the investor more leverage as it attempts to influence Pfizer’s turnaround strategy.

Cell therapy biotech Aurion eyes IPO despite legal pushback from investor

By Gabrielle Masson

Cell therapy biotech Aurion is moving forward with plans to IPO despite a pending lawsuit from one of its existing investors.

No deal: Sage rejects Biogen's buyout offer, scouts for strategic alternatives

By Zoey Becker

The company's board of directors unanimously rejected partner Biogen's $469 million buyout proposal, finding that it "significantly undervalues" the company and is not in the best interest of shareholders.

Gearing up to challenge Lilly in obesity, Kailera picks Zepbound brand leader as new commercial chief

By Andrea Park

Not long after reporting phase 2 data for one of its obesity candidates that appeared to put it on par with Eli Lilly’s Zepbound, Kailera Therapeutics is preparing for an eventual market launch with a new commercial leader.

Akero's stock doubles as midphase MASH trial generates 'transformational' data: analyst

By Nick Paul Taylor

Akero Therapeutics has hit a home run, reporting statistically significant results in two key 96-week metabolic dysfunction-associated steatohepatitis analyses to send its stock up about 100%.

After White House transition, FDA’s diversity guidance for clinical trials no longer available

By Gabrielle Masson

The FDA’s guidance detailing diversity action plans for clinical trials that evaluate drugs, devices and other medical products has been taken down from the agency’s website.

Bristol Myers, Pfizer tout new standards of care in colorectal cancer subtypes

By Angus Liu

Old drugs from Bristol Myers Squibb and Pfizer have delivered what the companies and researchers believe could establish them as new standard treatments for certain colorectal cancer patients.

Moderna, Novo Nordisk slammed for breaching UK drug marketing code yet again

By Nick Paul Taylor

Moderna and Novo Nordisk are once again in the bad books of the U.K.’s drug marketing watchdog. The repeat offenders received their latest dressing-downs over a gathering of healthcare professionals and problems with the disclosure of transfers of value, respectively.

Metsera eyes $289M IPO to fund phase 3 weight loss trial

By James Waldron

Metsera has set its sights on a hefty $289 million IPO as the next-gen obesity biotech seeks to fund a phase 3 trial of its GLP-1 receptor agonist.

Pfizer shells out nearly $60M to resolve Nurtec kickback claims inherited in Biohaven buyout

By Fraiser Kansteiner

Pfizer—which purchased Biohaven for $11.6 billion in 2022—is committing more than $59.7 million to resolve kickback allegations tied to its neuroscience subsidiary's migraine med Nurtec.

Author Siddhartha Mukherjee, LinkedIn co-founder Reid Hoffman connect to launch AI drug design startup

By Conor Hale

The author of the seminal cancer biography The Emperor Of All Maladies and the co-founder of LinkedIn are looking to connect their skills to the development of new medicines.

Allakos axes program, lays off 75% of staff and seeks strategic alternatives after phase 1 flop

By Nick Paul Taylor

Allakos is throwing in the towel. After seeing phase 1 data in hives, the biotech has decided to drop the drug candidate and lay off 75% of its employees to hunker down while exploring strategic alternatives.

Havas Life London rises from rebrand with eye on global health and rare disease communication

By Nick Paul Taylor

Havas Health Network has rebranded a U.K. agency. Havas Life Medicom is now Havas Life London, a group focused on brand, corporate and cause-related communications in global health and rare diseases.

Fierce podcasts

Don’t miss an episode

Recapping the 2025 J.P. Morgan Healthcare Conference

This week on “The Top Line,” we break down the biggest stories out of JPM, from J&J’s blockbuster acquisition of Intra-Cellular Therapies to former First Lady Jill Biden’s appearance at Fierce JPM Week.

Fierce's forecasts for the next year in biopharma

Learnings from Indiana's behavioral health system overhaul

Resources

Whitepaper

Communicating the Value of Biopharma Assets to Potential Investors

How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights.

Presented by: Blue Matter, strategic consultants in the life sciences