The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
BioSpace data show job postings live increased quarter over quarter, while layoffs fell year over year.
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.
The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating erythropoietic protoporphyria.
Richard Pazdur had spent 26 years at the FDA before stepping down last year due to disagreements with Commissioner Marty Makary about lowering the number of clinical trials required for a new drug application, Pazdur told the media.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.
FROM BIOSPACE INSIGHTS
As next-generation antibody-drug conjugates reshape cancer care, digital pathology and artificial intelligence are transforming how HER2 is measured. The advances aim to help clinicians identify low and ultra-low expressors, match patients to the right therapies and make more precise treatment decisions.
LATEST PODCASTS
Johns Hopkins’ Thomas Hartung discusses how drug discovery and development will change under evolving regulatory policies that embrace AI technology as well as organoid and other non-animal models of human biology.
In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe and Jennifer Fakish at Danaher Corporation. They discuss how antibody drug conjugates (ADCs) are transforming cancer care. With AI-powered pathology, doctors can now measure HER2 more precisely to match patients with the best treatments.
A lawsuit and FDA warning ensued after Hims & Hers launched a compounded version of Novo Nordisk’s new obesity pill, more Big Pharma report earnings—including from weight loss rivals Novo and Eli Lilly—and the gene therapy space sees another rejection.
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SPECIAL EDITIONS
Recent breakthroughs and three decades of progress in treating Huntington’s disease
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DEALS
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The pact between Madrigal Pharmaceuticals and Ruzhou Ribo Life Sciences could complement the former’s Rezdiffra, the first FDA-approved therapy for MASH. That drug made $287.3 million in the third quarter of 2025. -
The deal gets Lilly access to Orna’s in vivo CAR T technology. The biotech’s lead asset, which has yet to start clinical testing, is focused on B cell–driven autoimmune diseases. -
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklund, CEO of Circio and Jacob Becraft, Co-founder and CEO of Strand Therapeutics. They discuss how post-COVID, emerging platforms like circular and logic circuit RNA are expanding the field’s therapeutic horizons. -
The alliance will add to Roche’s RNAi efforts, which include the hypertension candidate zilbesiran, partnered with Alnylam under a July 2023 agreement. -
Moderna will continue to lead clinical development and manufacturing of the asset, while Recordati will handle commercialization of mRNA-3927, which is under development for the rare metabolic disorder propionic acidemia.
WEIGHT LOSS
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Eli Lilly has long been gearing up for the launch of orforglipron, announcing as early as February 2024 that it was ramping up manufacturing investments for the weight-loss pill. -
The oral version of Wegovy has made GLP-1 medicines more accessible and acceptable to many patients who had steered clear of injectable versions, healthcare analytics firm Truveta suggests. -
A lawsuit and FDA warning ensued after Hims & Hers launched a compounded version of Novo Nordisk’s new obesity pill, more Big Pharma report earnings—including from weight loss rivals Novo and Eli Lilly—and the gene therapy space sees another rejection. -
Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China. -
AstraZeneca will push the pill, elecoglipron, into a comprehensive late-stage program that will test the drug as a monotherapy, as part of a combination regimen and for several indications.
POLICY
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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation. -
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine. -
AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product. -
The FDA underwent significant changes during the first year of the second Trump administration, directly affecting business risk and opportunity. Understanding key 2025 trends will be critical to developing regulatory strategies and maximizing opportunities for success. -
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
If workloads aren’t adjusted as needed, the company’s priorities are already compromised. Executive coach Angela Justice explores what happens when goals move forward without removing unnecessary work and what to do about it.
At some point in your research career, you may find yourself transitioning from academia to industry or vice versa. To best set yourself up for success, adapt your approach to the specific scientific culture where you work.
Venture funds attending the J.P. Morgan Healthcare Conference said mounting funding pressures and Chinese competition have sharpened their focus on leadership qualities, from regulatory expertise and industry experience to the ability to scale—or step aside—as companies mature.
Clarity on employment terms is essential to protect careers. In this column, Kaye/Bassman’s Michael Pietrack speaks to employment attorney Howard Matalon, JD, partner at OlenderFeldman, on how to evaluate the fine print of an employment agreement.
Looking for a new opportunity in New Jersey? These nine companies have open roles that could be a great fit for you.
The difference between a job and a career is what you walk away with when it ends. Here’s how to evaluate if your role and environment are enabling capability building–and if your title is holding you back.
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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Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies. -
In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe and Jennifer Fakish at Danaher Corporation. They discuss how antibody drug conjugates (ADCs) are transforming cancer care. With AI-powered pathology, doctors can now measure HER2 more precisely to match patients with the best treatments. -
Despite the Phase 1 cull, CEO Vas Narasimhan on Wednesday maintained that Novartis continues to invest in its early-stage pipeline, looking for deals in the “sub-$2-billion range.” -
On its fourth quarter earnings call Wednesday, AbbVie CEO Robert Michael called oncology and neuroscience “underappreciated” areas of focus for the pharma. -
In its 2025 full year and fourth-quarter earnings call, Merck executives touted the merits of recent deals and what CEO Robert Davis called “probably the broadest and widest pipeline we’ve had in years.”
NEUROSCIENCE
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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market. -
The FDA in July last year declined to approve UX111 for Sanfilippo syndrome, a rare neurodegenerative disorder, citing manufacturing issues. Ultragenyx Pharmaceutical resubmitted its application ten days ago, expecting a six month review time. -
Sales of Johnson & Johnson’s esketamine-based nasal spray jumped in the fourth quarter last year, priming the pump for a suite of other pharmas, including AbbVie, champing at the bit with their own psychedelics. -
With Biogen’s multiple sclerosis portfolio facing more generic pressure than ever, the company is eyeing a busy late-stage pipeline and hunting for deals to build its return to growth. -
Bristol Myers Squibb delivered better than expected fourth quarter earnings, but Eliquis missed expectations while Cobenfy continues to struggle with uptake.
CELL AND GENE THERAPY
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more. -
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest? -
A recurring theme Tuesday morning at Phacilitate’s Advanced Therapies Week was the quickly emerging potential of in vivo approaches to cell and gene therapy—a trend also reflected in recent investments by Eli Lilly and Regeneron. -
The FDA recommended that REGENXBIO run a new study, treat more patients and include a placebo arm to support a resubmission for the gene therapy RGX-121. -
The gene therapy uses an AAV vector to restore healthy levels of the alpha-galactosidase enzyme, which is rendered dysfunctional in patients with Fabry disease, leading to the toxic build-up of lipids in cells.
