Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about one-quarter of patients. But Syndax’s Revuforj also has priority review in this indication, with a PDUFA date two months earlier.
The cancer conference overwhelms the senses and shows off the might of the pharmaceutical industry.
The candidate is being positioned as a potential oral competitor to Sanofi and Regeneron’s blockbuster Dupixent in allergy and inflammation indications.
Analysts said the data suggest “a strong treatment effect.” Jazz has filed for FDA approval for the combination, which could offer an alternative to monotherapy treatments from Roche and AstraZeneca.
In comments posted in response to the Trump administration’s pharma tariff investigation, companies and industry groups offered solutions to ease the impacts if the plan must go ahead.
Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab.
FEATURED STORIES
Nearly two years in with Zurzuvae, Biogen tackles an ‘all of the above market’ to find patients and battle stigma in postpartum depression.
R&D spending across the global pharmaceutical sector climbed 1.5% in 2024, according to unreleased data from Evaluate Pharma.
Vocal skeptics of COVID-19 vaccinations gave mRNA a bad name and government funding for mRNA research is now being cut. On the flip side, at least one CEO said the pandemic also provided “elevated acceleration” for the field, which also holds promise in therapeutics for cancer and rare diseases.
FROM BIOSPACE INSIGHTS
At Drexel University’s Graduate School of Biomedical Sciences and Professional Studies, graduate students and active professionals can take interdisciplinary, career-oriented programs designed to help launch their careers and take them to the next level.
LATEST PODCASTS
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses how collaboration and investment shape the the future of women’s health with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express concern about the FDA’s future; Pfizer’s obesity setback could be Viking’s gain; and BioSpace reveals the highest paid pharma CEOs.
Job Trends
Health and Human Services employees aren’t the only ones out of work. Thousands of private-sector biopharma professionals lost their jobs in the first quarter.
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SPECIAL EDITIONS
In the battle over drug prices, one sector of the healthcare industry has risen above all the players as the boogeyman: pharmacy benefit managers. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the lens now focused on PBMs’ business practices.
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
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%.
DEALS
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It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved. -
M&A and IPOs got off to a quick start in 2025 only to crash into a wall of policy challenges. Upfront payment for licensing transactions, however, grew as pharmas looked for less-risky deals. -
The Alchemab deal will further strengthen Lilly’s early-stage pipeline for amyotrophic lateral sclerosis, coming less than a year after the pharma licensed QurAlis’ antisense oligonucleotide to correct a specific protein alteration in ALS. -
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. -
Announcing first-quarter results, Biogen CEO Chris Viehbacher admitted that tariffs are “a new topic for us,” but said he does not expect major impacts—at least for 2025.
WEIGHT LOSS
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Like fellow Big Pharmas Eli Lilly and Johnson & Johnson, Amgen is urging the Trump administration to consider tax policy instead of tariffs to promote domestic pharma manufacturing. -
Eli Lilly CEO David Ricks is confident that weight loss med Zepbound is gaining market share at the expense of Wegovy, even as its rival strikes deals with CVS and Hims & Hers pharmacies. -
To say, as CEO David Ricks did, that this was a good quarter, is an understatement. Mounjaro in diabetes brought in $3.84 billion for the quarter while Zepbound in weight loss booked $2.31 billion. -
As Q1 2025 earnings season continues, tariffs remain top of mind for pharma CEOs and investors. Meanwhile, the American Association for Cancer Research’s annual event kicks off this year’s oncology conference season. Plus, will the FDA become politicized under HHS Secretary RFK Jr.? -
In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, formally barring compounders from producing their knockoff versions of the drug.
POLICY
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The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care. -
After a tense exchange, Senator Patty Murray (D-WA) told Kennedy that by implementing sweeping cuts to the HHS, he is “enacting his budget,” which “Congress has not passed.” -
Drugmakers will be expected to commit to aligning U.S. prices with the lowest price set in a group of peer nations for all brand products across all markets that do not currently have generic or biosimilar competition. -
The Most Favored Nation order is unlikely to deliver broad, sustained savings without triggering legal challenges, administrative friction and unintended consequences for both the healthcare sector and patient access. -
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
Learn how to leverage your end-of-year downtime to document achievements, update your professional presence and prepare for a successful 2025.
Based on how President-elect Donald Trump’s first administration handled immigration, experts are concerned about how his second term will impact foreign-born biopharma professionals. Two immigration attorneys discuss what may be ahead, including increased difficulty getting work visas.
At Drexel University’s Graduate School of Biomedical Sciences and Professional Studies, graduate students and active professionals can take interdisciplinary, career-oriented programs designed to help launch their careers and take them to the next level.
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.
Many biopharma professionals view smaller companies as having the best flexibility and remote work options, but that doesn’t mean their larger counterparts are failing in that area. Several professionals, including Apogee Therapeutics and Insmed executives, share their insights.
Check out five New York companies hiring biopharma professionals like you, including 2025 Best Places to Work winners.
HOTBEDS
REPORTS
This report investigates anticipated job search activity and hiring outlook for the remainder of 2024.
The job response rate has risen year over year, according to BioSpace data, indicating competition for roles posted on our website has increased.
BioSpace’s 2024 Salary Report explores the average salaries and salary trends of life sciences professionals.
CANCER
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The ODAC cited concerns with patient populations in clinical trials used to support the proposed expansion. Johnson & Johnson fared better, with the FDA’s cancer advisors voting to recommend Darzalex in patients with a certain type of multiple myeloma. -
The deal comes three months after Pfizer inked a PD-1/VEGF partnership with Summit Therapeutics, leading BMO Capital Markets to express confusion regarding the pharma’s overall strategy. -
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. -
The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed. -
As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that volunteers with little training are scrambling to secure the required expertise after workforce cuts decimated the adcomm planning office.
NEUROSCIENCE
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Despite a dip in sales and a recent schizophrenia stumble, the company drew an optimistic outlook for sales for the rest of the year, even as the specter of pharmaceutical tariffs looms. -
With a new raise provided by Flagship Pioneering, the new company is aiming to find “the silent window” before disease symptoms set in. -
Cobenfy’s late-stage flop is BMS’ second high-profile failure in as many weeks. The pharma announced last week that Camzyos was unable to improve disease burden in non-obstructive hypertrophic cardiomyopathy. -
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
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The Health and Human Services Secretary said that he will find and eliminate the cause of autism by September, an idea that suggests how little he knows about the condition.
CELL AND GENE THERAPY
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As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on. -
The cell and gene therapy company is cutting 47 employees and its entire lupus program to focus resources on two CAR Ts. The move follows a reconfiguration last year to move into immunology. -
Paul Stoffels left his perch as J&J’s chief scientific officer in 2022 to replace Galapagos’ founding CEO Onno van de Stolpe, inheriting a company that had suffered a series of clinical failures since its 1999 creation. -
Despite making an unsolicited bid for gene therapy maker bluebird bio, Ayrmid failed to deliver a binding offer after weeks of due diligence. Bluebird’s board recommended that it go with Carlyle and SK Capital Partner’s original offer to take the company private for $30 million. -
Stifel analysts said that Lexeo’s data showing reduced size and thickness of the heart’s left ventricle are “supportive of a drug effect” for the company’s gene therapy in Friedreich’s ataxia cardiomyopathy.
