Clinical Trials
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FDA, aiming to lower drug costs, moves to speed approval of biosimilars
The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help developers bring them to market more quickly and cheaply.
By Jonathan Gardner • Oct. 29, 2025 -
BridgeBio chalks up another win for its rare disease research
The company reported its second late-stage study success, this time with a drug that could become a new treatment standard for an uncommon endocrine disease.
By Ben Fidler • Oct. 29, 2025 -
Explore the Trendline➔
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TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
Merck kidney cancer drug succeeds in two large trials
The results could help expand use of Welireg, one of the medicines Merck is counting on to drive revenue growth when its top-selling immunotherapy Keytruda loses patent protection.
By Jonathan Gardner • Oct. 28, 2025 -
Gene editing
Intellia pauses two CRISPR drug studies after safety scare
A study volunteer receiving Intellia’s transthyretin amyloidosis treatment was hospitalized due to severe signs of liver stress, prompting the company to pause enrollment and dosing while evaluating a new safety protocol.
By Jonathan Gardner • Oct. 27, 2025 -
BridgeBio to seek approval of limb-girdle drug following new study data
The company intends to meet with the FDA to discuss results that showed a level of improvement on a marker of muscle stability that one executive described as a “home run.”
By Ben Fidler • Oct. 27, 2025 -
News roundup
Chugai buys a kidney biotech; ICER targets rising launch prices
Chugai is acquiring partial rights to a marketed IgA nephropathy drug. Elsewhere, ICER claimed Americans are often “overpaying” for medicines and Summit raised $500 million.
By BioPharma Dive staff • Oct. 24, 2025 -
Ventyx shares soar after study suggests cardiovascular benefits for experimental drug
The drug’s effects on cardiovascular and inflammation markers outshined its failure to spur weight loss, analysts wrote.
By Kristin Jensen • Oct. 23, 2025 -
Vaccines
Moderna says CMV vaccine once seen as future blockbuster fails key study
A shot analysts projected as a multibillion-dollar seller produced results “well below” the company’s expectations, heightening pressure on Moderna’s flagging respiratory vaccine business.
By Delilah Alvarado • Oct. 22, 2025 -
Sanofi drug acquired in buyout succeeds in rare disease trial
The drug’s success in a Phase 2 study in alpha-1 antitrypsin deficiency “validates” Sanofi’s 2024 acquisition of Inhibrx, according to one analyst.
By Delilah Alvarado • Oct. 22, 2025 -
Alector dementia drug, partnered with GSK, fails in key study
The negative readout led to a collapse in share price for Alector, which now plans to cut almost half of its workforce while refocusing and finding a new R&D leader.
By Kristin Jensen • Oct. 22, 2025 -
AstraZeneca, Daiichi’s Datroway excels in hard-to-treat breast cancer
Presented at the European Society for Medical Oncology, study results showed Datroway extended survival in breast cancer patients for whom immunotherapy is not an option.
By Delilah Alvarado • Oct. 20, 2025 -
Summit’s dual-acting drug scores lung cancer win
A closely watched trial in Chinese patients is raising hope that ivonescimab will outperform Keytruda in a large global study that could reshape first-line treatment regimens.
By Jonathan Gardner • Oct. 20, 2025 -
Exelixis shares dip on colorectal cancer data
Some on Wall Street weren’t too impressed with results from a pivotal trial that tested an Exelixis drug, zanzalintinib, in combination with Tecentriq.
By Jacob Bell • Oct. 20, 2025 -
Roche pill delays tumor progression in closely watched breast cancer study
Results presented at the European Society for Medical Oncology meeting could help separate Roche’s medicine from similar hormone-degrading drugs for breast tumors.
By Jonathan Gardner • Oct. 18, 2025 -
J&J claims success in study testing earlier Tecvayli use in multiple myeloma
The result marks a potential advance for dual-targeting antibody drugs like Tecvayli, which are currently relegated to later-line settings for the persistent blood cancer.
By Jonathan Gardner • Oct. 16, 2025 -
Obesity drugs
Lilly, battling skepticism, reinforces GLP-1 pill’s case with new study data
Some Wall Street analysts have questioned orforglipron’s sales outlook in obesity, but see great potential in diabetes, where on Wednesday it succeeded in two more late-stage trials.
By Kristin Jensen • Oct. 15, 2025 -
Sponsored by Pearson
[Podcast] The Progress Profile: Alzheimer’s Research in Focus
Discover the latest breakthroughs in Alzheimer's research, diagnosis, and prevention in this expert-led podcast series.
By BioPharma Dive's studioID • Oct. 15, 2025 -
Obesity drugs
Kailera nets $600M more to advance Zepbound-like obesity drug
Among the largest private biotech funding rounds this year, the financing will support global trials of an obesity shot that just succeeded in late-stage testing in China.
By Jonathan Gardner • Oct. 14, 2025 -
Sponsored by Norstella
Pharma’s real-world data dilemma: Strategic asset or wasted resource?
To maximize RWD’s potential, pharma companies should begin with their business or clinical goals.
By Ilan Behm, VP, Real-World Data Engagement, Norstella and Ted Search, General Manager, Real-World Data, Norstella • Oct. 13, 2025 -
Sponsored by Labcorp
Maximizing biomarker insights from minimal samples
Unlock value with optimized workflows and scalable technologies.
Oct. 13, 2025 -
Regeneron, with ‘game-changing’ new data, to seek approval of hearing loss gene therapy
Study results published in The New England Journal of Medicine show the therapy significantly improved hearing in nearly a dozen children with a rare, genetic form of deafness.
By Jacob Bell • Oct. 12, 2025 -
AstraZeneca, Daiichi drug extends survival in hard-to-treat breast cancer
The results could pave the way for Datroway to supplant chemotherapy in certain triple-negative tumors, adding to existing clearances in other breast and lung malignancies.
By Delilah Alvarado • Oct. 6, 2025 -
Obesity drugs
Skye shares crash as obesity drug falls short in key study
The findings are the latest setback for weight loss medicines that target a specific cannabinoid receptor and are meant to boost the effects of incretin therapies like Wegovy.
By Ben Fidler • Oct. 6, 2025 -
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Sponsored by 1nHealthThe advantage of engaging patient recruitment partners as strategic allies, not emergency backups
The secret to on-time trials? Engaging recruitment partners early.
By Ryan Day and Steve Wimmer • Oct. 6, 2025 -
Amgen claims ‘landmark’ study result that could widen heart drug’s use
In a first-of-its-kind finding, Amgen’s PCSK9 drug protected heart health when tested as a “primary prevention” therapy, which could pave the way for access to a much broader population.
By Jonathan Gardner • Oct. 2, 2025