Patients had adverse events after receiving a Fresenius Kabi medicine that experienced manufacturing deviations.
Despite meeting the primary endpoints in a Phase 3 trial, shares of Zealand Pharma dropped in premarket trading Thursday as the up to 9.8% weight loss reflected inferior loss to that generated by competitors.
Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
Sanofi and Regeneron have had a long and “sometimes contentious” partnership, BMO Capital Markets noted, as the companies contend with the looming loss of exclusivity of their blockbuster drug Dupixent.
Ebvallo, which Pierre Fabre Pharmaceuticals and Atara Biotherapeutics are proposing to treat a posttransplant complication, joins a wave of rejected or discouraged therapies on which the FDA has reversed previous guidance after the exit of former Commissioner Marty Makary.
Of the 38 companies receiving incentives, 31 will expand outside of Boston and Cambridge. Still, Boston and Cambridge are each expected to gain over 200 jobs. Tax incentive award recipients include AstraZeneca, Bristol Myers Squibb and Insulet.
FEATURED STORIES
After a frantic second quarter, M&A steadied with just under $30 billion across 22 total transactions, according to a BioSpace analysis.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
Stem cell therapies vary widely yet many physicians still treat them as interchangeable. A more credible model requires diagnostics, product characterization and conventional medical context to determine who and when should receive regenerative treatment.
Last year, 11 major M&A deals were signed with women-led biotechs. The industry is nowhere near on track to meet that bar for 2026.
Strange and bittersweet. That’s how Claire Mazumdar describes her plan to step down from the top spot at Bicara, a biotech she helped form, and head out on parental leave before transitioning into a new role.
To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and win market share.
LATEST PODCASTS
In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.
Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.
In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We look at the momentum behind radioligand therapy and how its diagnostic and therapeutic capabilities are improving care for more than 14 million patients worldwide.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
As Big Pharma adds AI technology to bolster drug development, a cadre of new, upstart biotechs are pushing drug discovery to new heights.
BioSpace takes stock of the psychedelic therapeutics space, which is once again on the cusp of its first FDA approval.
Job postings increase and competition dips, according to BioSpace data.
DEALS
-
Time has run out on BioNTech’s bid to locate buyers for sites in Idar-Oberstein, Marburg and Tübingen. Including staff at a Singapore plant also slated for closure, the move could impact 1,860 jobs. -
The all-stock deal gives Summit Therapeutics enough money to see through Phase 3 trials for the PD-1/VEGF bispecific ivonescimab—but keeps the asset fully in-house without giving up licensing rights. -
Investors looking for more transformative business development at Novo will have to wait, but a new partnership with China’s Hengrui Pharma adds a new weekly oral option to the Danish pharma’s early pipeline. -
Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda’s patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2 billion. -
Two RNA biotechs, ADARx Pharmaceuticals and City Therapeutics, are taking advantage of the IPO frenzy, which has led to a total of 27 newly public biotechs so far this year.
WEIGHT LOSS
-
EloraTZP—a combination of an amylin asset and Eli Lilly’s approved obesity drug Zepbound—made a clean sweep of the primary and secondary endpoints in a mid-stage trial of adults with obesity and type 2 diabetes, setting up the launch of a Phase 3 trial before the end of the year. -
Eli Lilly’s weight loss pill Foundayo has had a “slower-than-hoped” launch, according to BMO Capital Markets, which contended that the indirect comparison data—despite falling short of definitive proof of superiority—could help the Indiana giant build momentum for its oral drug. -
Roche’s anti-myostatin therapy emugrobart is unlikely to elicit meaningful weight loss, according to an interim mid-stage analysis, prompting the pharma to return the asset rights to its subsidiary Chugai Pharmaceutical. -
FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.” -
Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday.
POLICY
-
As Chinese companies push beyond “me-too” drugs and the country lays out a new five-year plan targeting a $522 billion–strong biotech industry by 2030, experts say more predictable funding and regulation could help the U.S. maintain its edge. -
Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites. -
CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA. -
Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program, representing some 89% of the branded drug market. -
The U.S. is scrambling to compete with a strategically positioned China on the biotech stage as the Asian country surpasses America in biomedical research and clinical trials. So far, China is winning.
CAREER HUB
In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.
A career setback can teach you something useful—or teach you the wrong lesson. Executive coach Angela Justice explains how one difficult experience can quietly shape the choices that follow.
With U.S. data science jobs projected to grow 35% over the next decade, a recruiter and talent strategy director discuss the qualifications, technical skills and mindset needed to land these coveted positions.
Funding announcements can signal future hiring activity, giving biotech professionals a chance to build relationships before positions are posted. Industry experts share how to identify the funding events, milestones and company indicators most likely to lead to new jobs.
An executive who is rarely short on ideas needs someone to pull their big ideas through to implementation. Kaye/Bassman’s Michael Pietrack explains why this person, who he calls the implementer, may be the most important hire in the building.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
Business stage is just one factor in whether biopharmas want job candidates to have oncology experience for oncology roles. Two recruiters explain when oncology expertise matters most, the mistakes job seekers make and how to make a good impression.
HOTBEDS
REPORTS
Gain the latest insights into the biopharma hiring landscape with BioSpace’s Biopharma Job Market Report Q2 2026. Explore the trends shaping talent acquisition, from rising job postings and sustained R&D hiring to the market activity signaling stronger hiring demand ahead.
Opportunities increased by the end of the first quarter, according to BioSpace data.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
CANCER
-
Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease. -
Merck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Capital Markets. -
Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up. -
Genentech’s agreement with Earendil Labs came the same day its parent company, Roche, inked a cardiometabolic and renal deal with Atavistik Bio for up to $2 billion. -
InnoCare Pharma is the latest addition to Eli Lilly’s dealmaking spree, which includes some of the biggest acquisitions this year: up to $7 billion for Kelonia Therapeutics in April and up to $7.8 billion for Centessa Pharmaceuticals in March.
NEUROSCIENCE
-
The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression. -
While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as Lewy body dementia. -
Ulefnersen, an RNA-targeted therapy being developed by Ionis Pharmaceuticals and Otsuka Pharmaceutical, improved measurements of functional impairment and survival in patients with a rare, genetic ALS subtype in a Phase 3 trial. The partners plan to approach the FDA with the results to determine potential pathways for approval. -
With a trillion-dollar market cap and a wildly successful GLP-1 portfolio, Eli Lilly isn’t resting on its laurels. At the Psych Congress 2026, the company presented early-stage data that could support the potential of its next-gen GLP-1 and GIP receptor agonist to treat diseases far beyond obesity. -
As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, triggering a temporary pause.
CELL AND GENE THERAPY
-
Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year. -
Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.
-
The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month. -
The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
-
Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
