In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.
The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward.
The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.
Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.
MapLight laid out the terms of its planned IPO in a regulatory filing on Monday, providing greater detail about what the funds will be used for.
Of the three highest bidders, Pfizer’s purchase proposal for Metsera was the lowest, regulatory documents reveal. The New York pharma, however, offered the smoothest transaction with the greatest likelihood of success.
FEATURED STORIES
The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges.
A new study in JAMA contradicts a series of statements made by HHS Secretary Robert F. Kennedy Jr. that paint vaccine advisory committees at the CDC and FDA as hopelessly corrupt.
While the 10-fold increase in dose over injectable Wegovy has raised questions about the launch, Novo Nordisk has assured investors it has the manufacturing capacity to roll out oral semaglutide without restrictions on supply.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
President Donald Trump loves a deal, but Most Favored Nation drug pricing isn’t a good one for anyone.
Novo Nordisk has plummeted back to Earth after a stunning rise driven by Ozempic and Wegovy. Can the storied Danish pharma recover?
LATEST PODCASTS
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.
Job Trends
Massachusetts’ increased investment in the life sciences industry includes boosting its life sciences tax incentive program by $10 million annually, aiding job creation in the state.
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the next big thing in obesity.
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.
DEALS
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Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space. -
AstraZeneca has put hundreds of millions of dollars into AI deals, with an eye toward not just accelerating the development of drugs that treat cancer after it appears but also in creating diagnostics that can catch cancer earlier than current methods allow. -
The acquisition of SiteOne provides a bit of diversification for Lilly, which has burrowed into the obesity and diabetes space with mega-blockbuster tirzepatide and several follow-on molecules. -
In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront. -
The deal helps revitalize the TREM2 target after the high-profile failure of AbbVie and Alector’s candidate last year.
WEIGHT LOSS
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Analysts at William Blair say dapiglutide’s 11.6% weight reduction at 28 weeks could still be better, given that Zealand’s study predominantly included men and enrolled patients with lower BMI at baseline. -
In combination with Eli Lilly’s tirzepatide, marketed as Zepbound for obesity, Scholar Rock’s monolonal antibody helped patients lose the same amount of weight as patients on tirzepatide alone while preserving more muscle mass. -
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines. -
At 12 weeks, weight loss ranged from 2.6% to 11.3%, compared to a gain of 0.2% in the placebo group. Guggenheim analysts were also impressed by the tolerability profile. -
For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharma’s amylin efforts underwhelmed investors.
POLICY
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As Trump has pressured drugmakers to lower the cost of medicines in the U.S., the pharma industry has coalesced behind a message of rebalancing what nations pay to better reflect the innovation and value of drugmaking. -
Citing other priorities—such as the upcoming U.S.-Russia summit—four anonymous sources claim that pharma tariffs could still be weeks away, according to Reuters. -
In this episode of Denatured, BioSpace’s head of insights Lori Ellis discusses the ‘enormous implications’ of patent policy changes with Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck. -
Alastair Thomson, chief data officer at the HHS sub-agency, announced his resignation in opposition to Health Secretary Robert F. Kennedy Jr.'s “stupid” decision to cancel $500 million worth of contracts focused on mRNA technology. -
The stop order came on Aug. 5, the same day Health Secretary Robert F. Kennedy Jr. terminated 22 mRNA vaccine projects under the Biomedical Advanced Research and Development Authority, though Vaxart’s candidate is protein-based.
This week, Carina discusses how to transition into a career in biotech when you don’t have lab experience. Plus, handling difficult interviews and getting a “dry” promotion.
A recent legal decision could signal the ultimate demise of the FTC’s final rule banning most noncompete clauses. A biotech talent expert discusses how that affects biopharma job searches.
For the second quarter of 2024, there were 25% fewer jobs posted live on BioSpace compared to the same quarter of 2023. The year-over-year job response rate rose from 14.6% to 15.3%.
When moving to a new role at the same company, it’s important to create a transition plan, understand your responsibilities and expectations and get to know your new team.
Interviews can be difficult in any field, but especially in a competitive industry like the life sciences. Read on to discover the best way to answer salary interview questions in our guide.
Plus, what to do if your offer is paused and how to manage work anxiety.
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 panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma. -
Johnson & Johnson’s $23.7 billion in second-quarter earnings, driven by cancer and neuroscience drugs, exceeded analyst expectations, while CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030. -
In advance of this week’s adcomm, the FDA flags ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 but was pulled from the market two years later after a confirmatory trial failed to improve progression-free survival. -
Shanghai-based LaNova Medicines—which has captured the attention of some of the biggest Western pharmas—will be folded into fellow Chinese company Sino Biopharmaceutical in a deal worth up to $951 million. -
Only with the adoption of digital imaging and AI-powered analysis will next-generation precision oncology therapies reach their full potential and ensure no eligible patient is overlooked.
NEUROSCIENCE
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After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in 2025, according to Jefferies. -
The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley.
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BPL-003 showed “robust” efficacy data in treatment-resistant depression, according to analysts from Jefferies, who noted that the asset could hit peak market sales of $1 billion. The results clear the way for the asset’s late-stage development and for the completion of a proposed merger with atai Life Sciences. -
The rise of monoclonal antibodies brought back hope for stalling or reversing the devastating neurodegenerative disease. Big Pharma has taken notice with a handful of high-value deals, GlobalData reports. -
Digging into a prespecified analysis for the mid-stage study, INmune Bio identified some clinical and biological benefits of its TNF inhibitor in patients with early Alzheimer’s disease who have at least two biomarkers of inflammation.
CELL AND GENE THERAPY
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Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.” -
The pivotal trial for Neurogene’s Rett syndrome gene therapy makes use of baseline controls and a rigorous endpoint that could help ensure a broader label for the drug product, if approved, according to analysts. -
The all-cash buyout, which gives AbbVie access to Capstan Therapeutics’ in vivo edited CAR T therapy for B cell–mediated autoimmune diseases, adds to a growing sense of momentum in M&A, according to BMO Capital Markets. -
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible. -
Jefferies analysts called the proxy filing, which is a standard disclosure after a merger agreement, “much more intriguing than normal” given the regulatory turmoil it revealed.
