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
Policy uncertainties are impacting biopharma dealmaking from continent to continent, with companies being asked to walk a tightrope on their relations with China.
Major pharmaceutical companies are committing billions to US manufacturing in an effort to avoid steep tariffs threatened by President Donald Trump.
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
FROM BIOSPACE INSIGHTS
Takeda Oncology US Head of Sales, Annette Montandon, discusses how embodying a patient-first approach is key to the success of colorectal cancer drug FRUZAQLA®.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis and Miruna Sasu, CEO of COTA, discuss the challenges of inclusion and exclusion criteria of clinical trial patients, and reflect on current investment approaches around women’s health.
BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures.
Job Trends
ImmunityBio will part with 10 employees this quarter. Last fall, it cut 31 employees. The moves come as the biotech works to advance Anktiva in non-small cell lung cancer.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
If it feels like there has never been a tougher time to look for work, you’re not alone—and you’re likely not wrong.
In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.
In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.
DEALS
-
Our CEO accidentally started a book club. Now we’re all dreaming of mega pharma mergers. -
As high prices and supply issues drive consumers to alternative markets for GLP-1s, physicians aren’t too interested in using these therapies to treat conditions like heart disease risk that have existing cheap standards of care. -
BridGene strikes another partnership with Takeda as the latter company continues its dealmaking streak, following high-ticket agreements with Keros Therapeutics, AC Immune and Degron Therapeutics in the past nine months. -
The proposed acquisition by global investment firms Carlyle and SK Capital Partners could net shareholders $3 per share plus potential CVR dollars and provide bluebird bio with primary capital to expand the commercial reach of its gene therapies. -
The agreement, in which Merck will pay the biotech an undisclosed initial sum to license drugs targeting a solid tumor, could net Epitopea up to $300 million down the line.
WEIGHT LOSS
-
Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage. -
Eli Lilly says Indianapolis-based Premier Weight Loss is cracking open auto-injector pens containing its blockbuster drug and repackaging them into separate doses. -
According to BMO Capital Markets, Rybelsus’ outcomes in SOUL were “inconsistent,” failing to significantly lower cardiovascular death and nonfatal stroke. -
Compounded versions could make up as much as 40% of the semaglutide market, said Novo Nordisk CEO Lars Fruergaard Jorgensen on Thursday, but the company hopes to win patients over. -
Lexicon’s LX9851 targets ACSL5, a liver enzyme involved in fat metabolism that helps moderate fat accumulation and slow down gastric emptying.
POLICY
-
Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman. -
Industry representatives will still be allowed at these meetings, but they will no longer have a spot on the advisory committee. -
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking. -
The Health and Human Services Secretary said that he will find and eliminate the cause of autism by September, an idea that suggests how little he knows about the condition. -
GeoVax was using its HHS contract to develop its next-generation multi-antigen COVID-19 vaccine, which is in Phase IIb development.
Candidates looking to enter biotech should focus on cultivating key skills, thoughtfully crafting their resumes and putting their best, most authentic foot forward in interviews. An internship, co-op or fellowship won’t hurt, either.
This webinar will help you discover effective strategies for launching your career in biotechnology. You will gain valuable insights from industry experts and leave with the essential tools you need to thrive in this dynamic field.
A clinical research associate is a professional who oversees clinical trials. Here are our top tips on how to become one.
For biopharma executives who are between roles, navigating the transitionary time can be challenging. However, they can remain visible and valuable so they’re ready to seize their next big opportunity.
Managers face a variety of challenges during their careers. Instead of falling into fight or flight, develop resilience to navigate the uncertain moments that pop up from time to time.
In our comprehensive guide to salary negotiation, we’ll teach you what a market salary is, how to research a market value salary and, ultimately, how to negotiate your salary according to market value.
HOTBEDS
IN CASE YOU MISSED IT
In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
REPORTS
As competition for life sciences talent peaks, BioSpace has undertaken research to determine what employers can do to ensure they don’t lose out on talent they actually want to hire and retain.
If people are your greatest asset, it is imperative that your organization maintains a positive employer brand presence and talent pipeline. This report covers how you can build a strong employer brand with prospective employees, current employees - and former employees.
In challenging conditions, how can employers optimize the employee experience to retain their top talent and make the most of their current teams?
CANCER
-
The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action complaint over the blood cancer drug Pomalyst. -
Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis. -
Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the hypothalamus taking Rhythm Pharmaceuticals’ Imcivree. -
An independent data monitoring board found that BeiGene’s ociperlimab was unlikely to significantly boost overall survival in patients with untreated NSCLC. -
Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down fully.
NEUROSCIENCE
-
After years of controversy and allegations of doctored data, Cassava is moving on from Alzheimer’s. -
The British pharmaceutical giant is working with the U.K. Dementia Research Institute to exploit a “natural randomization” experiment to determine whether 65- and 66-year-olds who received GSK’s shingles vaccine Shingrix have reduced dementia risk. -
The gene therapy world is in turmoil, but Arbor, armed with more than $1 billion in partnerships and raises, is going forward. -
Ionis and Ultragenyx are competing to develop oligonucleotide treatments for Angelman syndrome, but will Neuren’s peptide catch up? -
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
CELL AND GENE THERAPY
-
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year. -
Johnson & Johnson and Legend Biotech hope to hit blockbuster status for Carvykti this year. -
Facing declining valuations and funding challenges, public biotechs like bluebird bio are going private to restructure, reduce regulatory burdens and refocus on long-term growth. -
Roche acquired Spark Therapeutics in 2019 for $4.8 billion. -
Abecma made $406 million in 2024, of which BMS paid $43 million to 2seventy bio as part of their profit-sharing agreement.
