Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage.
A ripple effect of the NIH’s slashed 2026 budget will be felt throughout the biopharma ecosystem. Young companies must act now to weather the storm.
Delays in the decision dates for high-dose Eylea are linked to issues at a Catalent-owned facility. Once these are resolved, Regeneron expects “to receive favorable action” on these applications, CEO Leonard Schleifer told investors.
A U.K. Court of Appeals ruling confirms the validity of a patent covering modifications of mRNA used in Moderna’s vaccines.
It’s not often that a CEO outright dismisses M&A prospects, but Moderna CEO Stéphane Bancel says the mRNA biotech has enough programs on its hands.
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.
FEATURED STORIES
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.
Beginning this week in Chicago, the American Association for Cancer Research’s annual conference will feature presentations that could have far-reaching implications for breast and blood cancers and more.
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?
BioSpace examines the busiest corporate venture capital arms in the pharmaceutical industry. Novo Holdings, which made headlines last year with its $16.5 billion Catalent buy, topped the list.
The largest Chinese licensing deal behind Pfizer’s is Novartis’ partnership with Shanghai Argo Biopharma, worth potentially more than $4 billion.
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.
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
BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures.
In the second podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Kevin Marks, CEO of Delphia Therapeutics.
Job Trends
Genentech’s latest layoffs are the second round of workforce reductions this year, following the company’s announcement in April that it was letting go around 3% of employees.
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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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Our CEO accidentally started a book club. Now we’re all dreaming of mega pharma mergers.
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As high prices and supply issues drive consumers to alternative markets for GLP-1s, physicians aren’t too interested in using these therapies to treat conditions like heart disease risk that have existing cheap standards of care.
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BridGene strikes another partnership with Takeda as the latter company continues its dealmaking streak, following high-ticket agreements with Keros Therapeutics, AC Immune and Degron Therapeutics in the past nine months.
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The proposed acquisition by global investment firms Carlyle and SK Capital Partners could net shareholders $3 per share plus potential CVR dollars and provide bluebird bio with primary capital to expand the commercial reach of its gene therapies.
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The agreement, in which Merck will pay the biotech an undisclosed initial sum to license drugs targeting a solid tumor, could net Epitopea up to $300 million down the line.
WEIGHT LOSS
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Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis.
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Long considered resistant to economic downturns, the pharmaceutical industry may face a greater challenge this time around as GLP-1s dominate and the population grows older.
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Last week, The Trump administration reversed a Biden-era proposal for Medicare coverage of anti-obesity treatments. But on Monday, HHS suggested it is open to future policy considerations toward this end.
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Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the hypothalamus taking Rhythm Pharmaceuticals’ Imcivree.
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Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage.
POLICY
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Findings that U.S. companies can sue foreign rivals despite limited business operations in the country could dissuade drug developers from targeting the U.S. market, potentially benefiting domestic producers of biosimilars.
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The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.
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District Judge William Young, a nominee of Republican President Ronald Reagan, blasted the Trump administration’s NIH cuts as discriminatory and “bearing down on people of color because of their color.”
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HHS Secretary Robert F. Kennedy Jr.’s actions in recent months have raised concerns that he is taking a heavy-handed and unilateral approach to vaccine policy in the U.S.
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At a satellite kickoff event to the annual BIO meeting, investment bankers and VCs gave reasons for optimism amid a ‘volatile’ period for the industry.
If you overidentify with your job, there are ways to find self-worth outside of work, starting with using your transferable skills somewhere else.
Transitioning from team member to manager has its challenges, including managing ex-peers. There are a few ways you can make the change easier.
Odds are, you won’t love every job. Is that OK? And what should you do if you’re struggling to find happiness at work?
While biopharma professionals cited age discrimination as an issue in a new BioSpace report, it’s not the only factor affecting older and younger people’s job searches.
Learn how to discuss career gaps and how to be a great hiring manager and interviewer.
Dry promotions include new titles and responsibilities without higher pay. What should you do if you’re offered this type of promotion?
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 FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.
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Roche, along with Bristol Myers Squibb, Novo Nordisk, AbbVie, Eli Lilly and others, is making inroads into molecular glues to use in cancer, immunology and other applications.
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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.
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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.
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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.
NEUROSCIENCE
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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.
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Jefferies analysts predict Annexon’s tanruprubart could be approved by mid-2026.
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Jazz is being accused of anti-competitive practices regarding its narcolepsy drug, as generic competitors emerge on the market.
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GSK is paying to access ABL Bio’s Grabody-B platform, which potentially enables therapies to cross the blood-brain barrier.
CELL AND GENE THERAPY
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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.
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One day after the European Medicines Agency requested that three clinical trials of Elevidys be placed on hold after the death of a U.S. teenager, a data monitoring committee concluded that they should continue unchanged.
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Sangamo, which has been having cash problems, will receive $18 million upfront in licensing fees for its AAV capsid that in preclinical studies has shown the ability to cross the blood-brain barrier.
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Already reeling from years of market chaos, the announced departure of CBER chief Peter Marks sent a ripple across biopharma markets.
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Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down fully.