Six weeks after HHS Secretary RFK Jr. cited unexplained conflicts of interest in dismissing all 17 members of the CDC’s vaccine advisory committee, Democrats are asking for details.
While some analysts forecast the tariffs could mean billions in additional industry expenditure, others expect the overall impact to be “manageable.”
In a post on X, Health Secretary Robert F. Kennedy Jr. alleged that the Vaccine Injury Compensation Program has “devolved into a morass of inefficiency, favoritism, and outright corruption.”
BMS is spinning out a new company with five immunology assets, including oral drugs being developed for systemic lupus erythematosus and plaque psoriasis, and $300 million in funds from Bain Capital.
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday.
In a Phase Ib/IIa trial, 91% of patients receiving the highest dose of trontinemab were amyloid negative after seven months of treatment, representing what B. Riley Securities called a “paradigm shift” to first-generation FDA-approved antibodies.
FEATURED STORIES
Akero Therapeutics, 89bio, Boston Pharmaceuticals and more are working to bring novel treatment options for metabolic dysfunction-associated steatohepatitis to a market that could reach $16 billion by 2033.
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
Bo Wang is a renowned AI scientist at the University of Toronto. He’s bringing his open-source culture and computational biology to Xaira Therapeutics in June.
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.
While Novartis and Bayer got there first, AstraZeneca, Bristol Myers Squibb and Eli Lilly are all vying to bring their radiopharmaceutical assets to a market projected to be worth over $13 billion by 2033.
Several companies will head to the FDA seeking approval of new Duchenne muscular dystrophy treatments next year but the death of a patient taking Sarepta’s Elevidys raises important safety questions.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
LATEST PODCASTS
BridgeBio’s Attruby wins approval for transthyretin amyloid cardiomyopathy while the FDA accepts Alnylam’s application for Amvuttra in the indication; Cassava’s controversial Alzheimer’s drug flunks Phase III; Amgen’s MariTide fails to impress investors, Donald Trump’s controversial nominations continue.
In this episode of Denatured, BioSpace’s Head of Insights Lori and guests from Teva Pharmaceuticals and TOWER Capital Group discuss how critical it is to incorporate women into leadership positions and board rooms as a sound investment strategy.
Trump fingers Robert F. Kennedy Jr. to lead the HHS, lupus and ATTR-CM dominate headlines this week, bluebird bio has a cash gap to leap and RegenxBio eyes Sarepta in Duchenne muscular dystrophy.
Job Trends
Takeda announced topline data from its SKYLINE and SKYWAY studies. SKYLINE was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome.1 Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo.
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SPECIAL EDITIONS
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
DEALS
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High profile failures and long timeframes for revenue have shifted investment away from Phase I, as VCs seek to mitigate risk, Pitchbook said in its 2025 outlook. -
BioArctic received $100 million upfront with another $1.25 billion in potential milestone payments on the line for two pyroglutamate-amyloid-beta antibodies. -
Photys is eligible for up to $186 million from Novo Nordisk for its PHICS small molecules that pair a kinase to a disease-causing protein for phosphorylation. -
BioSpace Senior Editor Annalee Armstrong reflects on the year that was, and what’s to come in 2025. -
The Novo-Catalent deal now moving ahead highlights unprecedented investment in manufacturing, while also standing out as an exception to the unspoken rule of keeping M&As to less than $5 billion this year.
WEIGHT LOSS
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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. -
Amid growing concern of the overuse and misuse of obesity drugs, the UK’s pharmacies regulator rolled out stricter guidelines for online pharmacies selling medicines including Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro. -
The U.S. Centers for Medicare and Medicaid Services has named Novo Nordisk’s Wegovy, Ozempic and Rybelsus as part of the second round of the IRA drug price negotiation program, even as the pharma challenges the program. -
Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
POLICY
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The package revives President Donald Trump’s much-maligned Most Favored Nation rule but goes further into the private markets and beyond, leveraging the patent system, drug importation and more. -
The FDA and CDC have also recommended pausing the use of Ixchiq in seniors 60 years and older while safety investigations are ongoing. -
As the Trump administration slashes funding for HIV-related research and infrastructure, Gilead, Immunocore and more are targeting the next goalpost: a cure. -
With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over. -
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.
To be self-employed in the life sciences, you must have a strong network and background and experience in a relevant area.
While MBAs can reflect positively on job applicants, work experience can often be more valuable, depending on the area.
If management isn’t your strength, there are several upper-level positions that don’t require you to manage others. Here are five high-paying life science jobs that don’t include management.
Ageism, or discrimination against an individual based on their age, is a common barrier many older individuals face in the workplace. Fortunately, there are steps that can be taken to mitigate this discrimination.
Job hopping– frequently changing jobs, typically within a short period of time – gained popularity with the onset of COVID-19 and is still popular now. Here’s what recruiters think about job hopping.
Can ChatGPT help you find a new job in an industry as complex as the life sciences? BioSpace’s career editor decided to put it to the test - here’s what she discovered.
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 French pharma is getting Black Diamond’s de-prioritized molecule for non-small cell lung cancers with specific mutations whose development had been paused to save money. -
Roche’s up to $1 billion investment will provide access to Oxford BioTherapeutics’ antibody-drug conjugate platform for undisclosed cancer targets. -
Monday was a busy day for AstraZeneca, which also paid up to $1 billion to acquire Belgian biotech EsoBiotec and its cell therapy pipeline and technology. -
Japan-based Taiho Pharmaceutical has worked with Araris Biotech since 2023 developing antibody-drug conjugates for the oncology space. -
Pfizer was studying PF-07820435, an orally available agonist of the STING protein, for solid tumors.
NEUROSCIENCE
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The Phase IIa results continue a surge of momentum in a treatment space that last week saw the approval of Vertex’s Journavx as the first novel mechanism for acute pain in decades. -
In a Phase IIb trial, GH001 elicited significant drops in treatment-resistant depression. The news comes less than two weeks after J&J secured FDA monotherapy approval for its esketamine nasal spray Spravato in the same indication. -
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.
CELL AND GENE THERAPY
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As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune diseases, a continued appetite for next-generation obesity drugs and an increased focus on neuromuscular, kidney and cardiovascular diseases. -
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.
