The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the rollout immediately.
The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action dates.
The company discontinued development last month of its most mature asset, RLYB212, following disappointing mid-stage pharmacokinetic findings in a rare bleeding disorder.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its COVID-19 shot, CEO John Jacobs said on the company’s Q1 earnings call: “When we have it, we’ll have it. Until then, we don’t have it.”
The cell engineering company, co-founded by oncologist and writer Siddhartha Mukherjee, does not see a path forward for its pipeline of early-stage cell therapies for two different types of cancer.
FEATURED STORIES
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.
As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out.
Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh speculate on the impending Trump administration, discuss current challenges faced by CEOs and weigh investment in GLP-1s.
Job Trends
Generative AI could enhance and accelerate the way people work on clinical trials. In this Q&A, a management consultant shares his insights on benefits, risks and more.
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SPECIAL EDITIONS
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
DEALS
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Biogen’s proposed acquisition comes after two difficult years of regulatory and clinical challenges, during which shares of Sage Therapeutics have fallen by more than 90%. -
The Biotech Ecosystem Venture Fund will combine the sourcing capabilities of venture capital firm Andreessen Horowitz (a16z) with Eli Lilly’s expertise in R&D—plus half a billion in capital from the Big Pharma. -
Initial rounds of VC financing totaled $7.7 billion over 137 deals for biopharma in 2024, compared to $3.8 billion over 156 deals in 2023. -
J.P. Morgan releases its quarterly look-ahead days before the entire biopharma industry descends on San Francisco for the annual J.P. Morgan Healthcare Conference. -
BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.
WEIGHT LOSS
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Novo Nordisk shares tumbled last year when obesity candidate CagriSema failed to clear a weight loss bar of 25%. Now, executives are taking another look at the data but steering clear of making hard bets. -
As Eli Lilly ends the year with Zepbound in good supply, TD Cowen analyst Steve Scala asked CEO David Ricks if the company has taken the GLP-1 supply chain too far. -
Wegovy sales increased by more than 100% over 2024. But that wasn’t enough to satiate analysts who want to know why Novo Nordisk can’t access more patients, particularly in the U.S. -
Amgen outperformed expectations in the fourth quarter of 2024, but revealed an FDA hold on early-stage obesity asset AMG 513 and the discontinuation of other programs. -
Just over a year after striking an obesity deal with Novo Nordisk, an SEC filing shows Flagship Pioneering spinout Omega Therapeutics is days away from bankruptcy and will lay off up to 17 employees.
POLICY
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Kennedy, a long-time opponent of vaccines, stated that the MMR vaccine is “the most effective way” to combat the measles outbreak, which has already claimed the lives of two children in the U.S. -
Pharma’s reprieve from Donald Trump’s tariffs is expected to be temporary, with Leerink analysts anticipating possible sector-specific duties “in the next month or so.” -
With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask. -
Trump has repeatedly called April 2 “Liberation Day,” alluding to a more sweeping and aggressive set of tariffs. Leerink Partners analysts said that the risks from Trump’s tariffs on the biopharma industry are “underappreciated.” -
Johnson & Johnson will not appeal the dismissal of its bankruptcy proposal.
Plus, what to do if your offer is paused and how to manage work anxiety.
If you overidentify with your job, there are ways to find self-worth outside of work, starting with using your transferable skills somewhere else.
Transitioning from team member to manager has its challenges, including managing ex-peers. There are a few ways you can make the change easier.
Odds are, you won’t love every job. Is that OK? And what should you do if you’re struggling to find happiness at work?
While biopharma professionals cited age discrimination as an issue in a new BioSpace report, it’s not the only factor affecting older and younger people’s job searches.
Learn how to discuss career gaps and how to be a great hiring manager and interviewer.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the drug in gastric and gastroesophageal cancers as BeiGene also pushes forward a pipeline of novel cancer therapies. -
The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers. -
Protagonist Therapeutics notches a milestone in its pact with Takeda for rusfertide. New data show that many patients with a chronic blood cancer taking the drug didn’t need to have their blood removed to bring down dangerously high hemocrit levels. -
More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO. -
The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind.
NEUROSCIENCE
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After the Phase II failure of its lead asset from Cerevel, AbbVie is resetting expectations and narrowing the clinical program to an adjunct approach—for now. -
Analysts were unfazed by the news that Takeda will cease development of soticlestat after Phase III failures, while responding positively to the announcement that Julie Kim will take the helm of the Japanese giant in 2026. -
Inhibikase’s setback continues biopharma’s losing streak against Parkinson’s, marked by several clinical failures and abandoned assets in recent months. -
The company, co-founded by Nobel Laureate Craig Mello, aims to push molecules for Huntington’s and a form of epilepsy into Phase I trials, with additional preclinical assets targeting Parkinson’s and Alzheimer’s. -
Little information has emerged about osavampator, a potentially first-in-class drug, since its promising Phase II performance last spring.
CELL AND GENE THERAPY
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Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs. -
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies. -
Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes. -
Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines. -
In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.
