The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent staffing exodus.
Following challenges with its drug candidate bexotegrast and announcement of a limited-duration stockholder rights program, Pliant is paring back its workforce.
No Patient Left Behind says that drug value assessments used in countries like Canada and Germany undervalue innovative medicines by 90% and mislead U.S. policymakers into thinking Americans are overpaying.
After multiple rounds of layoffs that cut Kronos down to just 10 people, the small molecule biotech has accepted a buyout offer from Kevin Tang’s Concentra Biosciences.
Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as per the Associated Press. Some food scientists involved in testing will also be reinstated.
In an internal memo, the World Health Organization signaled its support for anti-obesity drugs like Wegovy and Zepbound, which the agency decided against listing in 2023, the last time the Essential Medicines list was updated.
FEATURED STORIES
FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.
Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
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.
FROM BIOSPACE INSIGHTS
BioSpace’s Employment Outlook report investigates anticipated job search activity and hiring outlook in 2024 as well as how the current workforce is currently faring
LATEST PODCASTS
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis and Miruna Sasu, CEO of COTA, discuss life sciences investment and the potential for disruption.
As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics.
Job Trends
CytomX’s workforce cuts could leave the biotech with fewer than 75 employees as it focuses resources on its wholly owned clinical-stage programs, most notably an antibody-drug conjugate for advanced metastatic colorectal cancer.
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SPECIAL EDITIONS
In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
DEALS
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Faced with the encroaching threats of patent expirations and generics, biopharma companies in 2024 invested 33% more in licensing deals, on average, than in 2023 with an eye toward enriching their pipelines with novel and potentially more effective therapies. -
With just one asset in weight loss moving through the clinic, Pfizer targets the space for potential dealmaking, as well as bringing assets over from China. -
Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking. -
Novartis was among the most prolific pharma dealmakers in 2024, a trend that it expects to continue with more bolt-on deals this year to set up for sustainable long-term growth. -
Sanofi’s jump in earnings comes with an increased emphasis on R&D and vaccines, plus an eye cast toward M&A to shore up its pipeline.
WEIGHT LOSS
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Novo will license UTB251, a triple hormone receptor agonist that in mid-2023 achieved 24% weight reduction at 48 weeks in a mid-stage study. -
The explosion of GLP-1 weight loss drugs is reminiscent of the early days of PD-1 inhibitors, but key market differences suggest history may not repeat itself. -
Under the terms of the agreement, OPKO will accept 60% of the development costs, while Entera will shoulder 40%. -
The company unveiled plans last week to test its GLP-1/glucagon dual receptor agonist in alcohol use disorder and alcohol-related liver disease. -
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.
FDA
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As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out. -
Analysts at William Blair expect drug developers will continue to perform “at least some animal testing” on their investigational products. Though the process to phase out animal testing will begin “immediately,” no specific timetable was given. -
Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration. -
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming. -
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.
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.
During the job application and interview process, candidates who lie to prospective employers and those who don’t properly highlight their accomplishments can find it difficult to land—or keep—their next role. We asked experts how to sell yourself positively and honestly.
Dealing with a toxic co-worker can be exhausting, and it can make your workplace more stressful. There are a few ways to make it easier, including developing healthy coping mechanisms and even talking it out with your colleague.
Job security is a hot topic among biopharma professionals. A career coach offers advice for how to evaluate and build it up and what to do if that evaluation leaves you worried.
Good company culture is a crucial aspect of professional life. Look at these 11 important indications of good workplace culture before accepting a job offer or use them to evaluate your new employer.
An appreciation for practicality, independent thinking and patient care can help disrupt the bureaucracy of Big Pharma.
HOTBEDS
REPORTS
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?
In the 2020 US Life Sciences Diversity & Inclusion report, BioSpace dives into how different segments of employees experience and perceive policies, attitudes and actions. Our data suggests that there are significant disparities between segments.
CANCER
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The German conglomerate announced a licensing agreement with Puhe BioPharma for a PRMT5 inhibitor used in a variety of cancers. Financial details of the deal were not disclosed. -
AbbVie claims that Genmab turned a blind eye to trade secret theft allegedly used to support the development of ProfoundBio’s investigational antibody-drug conjugates. Genmab acquired ProfoundBio in May 2024. -
Adaptimmune is rolling out its T cell therapy Tecelra for synovial sarcoma, recording $1.2 million in sales since its approval in August 2024. Nevertheless, it is pausing development of two oncology assets to save money. -
With Keytruda, the best-selling drug in the world, facing the end of exclusivity in 2028, BioSpace looks at five drugs that have taken the leap off the patent cliff. -
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.
NEUROSCIENCE
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Analysts do not believe the Phase III stumble for aticaprant will derail J&J’s broader neuroscience strategy, particularly given its recent $14.6 billion acquisition of Intra-Cellular Therapeutics and the success of Spravato for treatment-resistant depression. -
The new formulation of Keytruda, currently under FDA review, is sparking conflict with Halozyme, which makes enzymes that convert intravenous drugs into injectable versions. -
Biohaven in recent months has reported a clinical stumble in spinal muscular atrophy, alongside a Phase I readout for its protein degrader candidate that investors found underwhelming. -
After failing to hit the primary endpoint in a Phase III trial, Neumora is remixing study parameters in two replicate trials, with data expected in the first half of 2026. -
Despite not differentiating itself from placebo, the Texas-based company said it plans to push pilavapadin into Phase III trials before long.
CELL AND GENE THERAPY
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Abecma made $406 million in 2024, of which BMS paid $43 million to 2seventy bio as part of their profit-sharing agreement. -
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. -
On the agenda for the FDA this month are two RNA-based treatments for rare diseases. -
The search for a partner for zerlasiran is ongoing, according to Silence. In the meantime, the biotech will focus its resources on divesiran, which it is testing for polycythemia vera and other hematologic indications. -
ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, Niemann-Pick disease type C, metachromatic leukodystrophy and more.
