Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues
CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
Texas Attorney General Ken Paxton claims that through an alleged kickback scheme Eli Lilly “fraudulently sought to maximize profits at taxpayer expense.”
Insmed’s Brinsupri is the first DPP1 inhibitor approved by the FDA and the first treatment for bronchiectasis to reach the market.
Jefferies analysts said these detailed safety outcomes confirm the gene therapy’s positive risk/benefit profile in ambulatory patients with Duchenne muscular dystrophy.
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.
For $1.3 billion in aggregate—including upfront and milestone payments—Bayer will get exclusive global access to Kumquat Biosciences’ small-molecule KRAS G12D blocker.
FEATURED STORIES
Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.
TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and shuttered businesses. Here are five biopharma players staying alive with differentiated candidates against the once promising immuno-oncology target.
Slashing adverse drug reactions through pharmacogenetics and advanced AI could help rehabilitate the pharmaceutical industry’s reputation amid mounting criticism.
Why did two private equity firms with more than $460 billion under management want a little old gene therapy biotech called bluebird bio? We wanted to know.
Analysts believe that Gilead’s new PrEP drug Yeztugo could reach peak sales of $4.5 billion. Not if GSK has anything to say about it.
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.”
FROM BIOSPACE INSIGHTS
Protocol design optimization and timely engagement of regulators are the crux of optimized, patient-centric clinical trials.
LATEST PODCASTS
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.
China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director Vinay Prasad reveal new COVID-19 vaccine strategy following Novavax approval; ODAC underway after chaotic planning; more.
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
Job Trends
Looking for a biopharma job in Pennsylvania? Check out the BioSpace list of six companies hiring life sciences professionals like you.
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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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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. -
BioSpace’s NextGen companies are rising in one of the most confounding biotech markets ever experienced. Executives sounded off on how to keep your head above water during our webinar, Are We There Yet? -
The largest Chinese licensing deal behind Pfizer’s is Novartis’ partnership with Shanghai Argo Biopharma, worth potentially more than $4 billion. -
The star of the acquisition is the enzyme replacement therapy INZ-701, being developed for the rare disease ENPP1 deficiency.
WEIGHT LOSS
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Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy. -
Eli Lilly joins up with Camurus to make long-acting versions of the pharma’s obesity and diabetes drugs, joining the industry’s growing pipeline of programs that are differentiated by the frequency of dosing. -
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. -
Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab. -
The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.
POLICY
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The decision follows last month’s vote of the CDC’s revamped vaccine advisory committee. Thimerosal, mostly removed from vaccines decades ago, has long been a target of anti-vaccine advocates for unfounded links to autism and adverse health outcomes. -
Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program. -
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency. -
According to Makary, reducing user fees—which make up just under half of the FDA’s budget—could make it easier for smaller companies, individual investors and academics to participate in the process. -
Despite the FDA commissioner’s promises of partnership and collaboration, personnel changes and continued federal cuts create uncertainty for an industry already struggling with nearly half a decade of investment scarcity.
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.
Plus, learn about what to expect in initial interviews and how to time your post-Ph.D. job search for maximum success.
Massachusetts’ biopharma jobs increased 2.6% in 2023, according to the MassBio Industry Snapshot. Whether the state’s jobs grow in 2024 remains to be seen based on this year’s layoffs and seemingly slowed hiring based on BioSpace data.
The federal judge’s decision Tuesday said the Federal Trade Commission exceeded its statutory authority in implementing a final rule aimed at restricting noncompete clauses.
Massachusetts’ new salary range transparency law can be a tool for companies looking to attract biopharma professionals while also helping candidates and current employees improve their job searches and salaries, according to two experts.
HOTBEDS
REPORTS
How does being Black affect the workplace experience as a life sciences professional? BioSpace surveyed our community to gain a greater understanding of Black employees’ feelings of inclusion and their perspectives on employer DEI initiatives.
Over the last two decades, women have achieved near equal levels of representation in life sciences - though there are distinct gaps in leadership and pay equity. The experience of women also differs vastly depending on age, race, and other factors.
How does age affect employees’ experiences in the workplace? This report examines the intersection of age along with gender and other demographics.
CANCER
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Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases. -
In May, Revolution Medicines projected its cash and equivalents of $2.1 billion would last into the second half of 2027. With new funding from Royalty Pharma, the biotech has withdrawn that runway end date. -
In combination with Roche’s PD-L1 blocker Tecentriq, zanzalintinib bested Bayer’s Stivarga. Exelixis is positioning the drug candidate as a successor to cabozantinib, which is set to lose patent exclusivity in 2030. -
Venclexta, when combined with azacitidine, elicited an overall survival benefit below 10% in patients with myelodysplastic syndromes. -
The deal gets NextCure the rights to Simcere’s novel ADC for solid tumors outside of China.
NEUROSCIENCE
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The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026. -
Jefferies analysts said on Tuesday that Ventyx could leverage its mid-stage data for VTX3232 to position the oral drug candidate as a treatment for other neurodegenerative diseases, including Alzheimer’s. -
Analysts at Jefferies give Roche and Prothena’s Phase III study just a 25% to 40% probability of success. -
Stifel analysts said the deal “feels like an unremarkable outcome for a company that was once one of the hottest stories in CNS.” Supernus’ offer beats Biogen’s unsolicited bid of about $7.22 per share, which arrived with a thud in late January. -
Avidity has been given the go-ahead by the FDA to request accelerated approval of delpacibart braxlosiran—potentially the first disease-modifying treatment for facioscapulohumeral muscular dystrophy—with an application in the second half of 2026.
CELL AND GENE THERAPY
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Analysts at Truist Securities called J&J’s CAR T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta. -
Sarepta’s shares crashed 41% in premarket trading Monday morning to $21.01 after the biotech reported a second death from acute liver failure, a known side effect of adeno-associated virus-based gene therapies. -
The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration. -
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one. -
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
