The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside experts.
The high court found that members of a task force that determines what preventive drugs must be covered can be removed at will by HHS Secretary Robert F. Kennedy Jr.
The revamped and “more anti-vax skewed ACIP committee” at the CDC “has a bone to pick with mRNA vaccines,” according to Truist Securities analysts. Meanwhile, the FDA moves forward on having Pfizer/BioNTech and Moderna update labels for their COVID vaccines.
The FDA found that data from a single Phase II study were “insufficient” to justify an accelerated approval review for sevasemten in Becker muscular dystrophy.
Altimmune’s pemvidutide failed to significantly improve fibrosis in MASH patients in a Phase IIb study. The biotech crashed 53% in the aftermath of the readout.
Calico will leverage 9MW3811’s anti-inflammatory mechanism to advance its mission of addressing aging-related diseases.
FEATURED STORIES
A handful of billion-dollar deals in the rare disease space highlights the uptick in Big Pharma’s investment, but it’s still extremely low compared to the money flowing to more common indications.
A judge in the U.K. last month sided with Pfizer over GSK in a respiratory syncytial virus vaccine patent lawsuit, positioning both companies to compete for that market and laying down a marker for ongoing legal clashes in other parts of the world.
Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
With the failure of AbbVie’s emraclidine in two mid-stage trials, Bristol Myers Squibb’s Cobenfy is ‘sole muscarinic winner.’
Bluebird has just two quarters until it’s out of cash. Executives are looking for financing to extend that runway to a projected breakeven point before the end of 2025, with analysts worried they won’t make it.
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
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
These days you can hardly move without figuratively bumping into antibody-drug conjugates (ADCs). This week we discuss Pfizer’s strategic priorities for oncology - focused on ADCs and less on small molecules - and how the market is being influenced by the IRA.
This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series.
Job Trends
The board of directors of Eli Lilly and Company has declared a dividend for the second quarter of 2024 of $1.30 per share on outstanding common stock.
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SPECIAL EDITIONS
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.
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.
DEALS
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Ono Pharmaceutical will pay $25.60 per share in an all-cash deal to buy Deciphera Pharmaceuticals for its potential blockbuster oncology drugs and U.S. sales infrastructure, the companies said Monday. -
Citing anonymous sources involved in a Phase III trial, STAT News reported Sunday that MorphoSys’ pelabresib may worsen the risk of progression to acute myeloid leukemia, potentially putting Novartis’ proposed $2.9 billion acquisition at risk. -
Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio? -
Here’s how to assess whether to develop a new therapy by building a proprietary platform, acquiring another company or asset or partnering with an established entity. -
CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.
WEIGHT LOSS
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Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions. -
BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial. -
Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist. -
Novo Nordisk’s continuing supply problems for semaglutide come as the pharma tries to expand the drug’s indication, opening it up to more patients—and potentially to heavier production pressures. -
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
POLICY
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While the former Biden administration showcased the Inflation Reduction Act as a key victory in the fight over high drug prices in the U.S., Trump has so far been mum on how the controversial law could evolve in the coming years. -
Senators on the Health, Education, Labor and Pensions committee were critical of Kennedy’s long history as an anti-vaccine campaigner. -
Kennedy’s confirmation hearing on Wednesday became heated as Democratic senators grilled the nominee for HHS Secretary on his previous statements about vaccine safety. -
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.
Getting job-hunting and career advice is hard, especially when you get it from those who have worked for decades. Some advice is still helpful today, like making a good impression, but others are considered counter-productive.
The salary expectation question is one of the most difficult questions asked during a job interview. Here’s how you can answer the question perfectly.
The coronavirus disease (COVID-19) pandemic that has ravaged across the globe has demanded more experts in microbiology, particularly jobs in virology.
BioSpace’s Pharm Country Hotbed ranges from Connecticut, New York, New Jersey, Pennsylvania and Rhode Island.
“The Great Resignation” is a term that’s been coined to describe the wave of people leaving their jobs for other opportunities or exiting the workforce altogether.
A resume is your introduction to a potential employer, and as the saying goes, “You only get one chance to make a good first impression.” Follow these resume writing tips today.
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 deal with Tubulis will help Gilead regain its footing in the ADC space following the withdrawal of Trodelvy in bladder cancer and its late-stage fail in NSCLC. -
Alongside the layoffs, Alligator will also suspend work on all of its earlier-stage assets and devote its resources to lead candidate mitazalimab, being developed for the frontline treatment of metastatic pancreatic cancer. -
The cancers were diagnosed 19 to 92 months after Skysona treatment. -
At the conference, AstraZeneca and Daiichi Sankyo will present their case for Dato-DXd in NSCLC, while BioNTech and Merus will reveal promising mid-stage data for their respective cancer candidates. -
Emboldened by technological advances and a deeper knowledge of glioblastoma, Merck, Kazia Therapeutics, CorriXR Therapeutics and others are targeting the often-fatal brain tumor.
NEUROSCIENCE
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Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia. -
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions. -
BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward. -
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline. -
Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
CELL AND GENE THERAPY
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Johnson & Johnson and Legend Biotech’s Carvykti cell therapy significantly improved survival in patients with multiple myeloma when used in the second-line setting, the companies announced on Tuesday. -
Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review. -
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment. -
After winning expanded approval for its gene therapy for Duchenne muscular dystrophy, Sarepta’s leadership and analysts see a sizeable commercial opportunity on the horizon. -
Exsilio Therapeutics emerged from stealth on Tuesday with a platform that leverages mRNA technology to develop redosable genomic medicines for a range of complex diseases.
