Clinical Trials: Page 9
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Sponsored by Cullinan Therapeutics
A vision for the future of lung cancer treatment
Precision medicine for lung cancer has evolved. But what about mutations that resist treatment?
By Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics • June 2, 2025 -
ASCO25
A funding flashpoint, Pfizer’s $1B poster and AstraZeneca advertising
A colon cancer study highlighted the importance of the National Cancer Institute, while the sickle cell treatment Casgevy got a surprising spotlight.
By Ned Pagliarulo , Jonathan Gardner • June 1, 2025 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
ASCO25
AstraZeneca drug could help keep a common breast cancer at bay
Data presented at ASCO show that swapping in the oral drug camizestrant for an older therapy helped sustain the benefit of initial treatment, potentially opening a novel step in patient care.
By Ned Pagliarulo • June 1, 2025 -
ASCO25
Full Arvinas, Pfizer data confirm potential, limits of ‘Protac’ drug in breast cancer
While vepdegestrant outperformed a standard treatment option in a subtype of patients, the benefit on progression-free survival was modest.
By Delilah Alvarado • Updated May 31, 2025 -
ASCO25
At ASCO, Enhertu cements growing role in stomach cancer care
AstraZeneca and Daiichi Sankyo’s drug extended survival by 30% compared to a widely used regimen, further establishing its importance as a second-line treatment option.
By Jonathan Gardner • Updated May 31, 2025 -
New Summit data could slow US approval plans for PD-1/VEGF drug
Ivonescimab helped cut the risk of lung tumor progression in half in a multi-country Phase 3 trial. But it hasn’t yet clearly extended survival, which will be necessary to support an FDA submission.
By Ben Fidler • May 30, 2025 -
Mixed COPD results for Regeneron, Sanofi drug cloud approval chances
Results released Friday show itepekimab succeeded in one Phase 3 trial but failed in a second, sinking shares of both partner companies.
By Ned Pagliarulo • May 30, 2025 -
Obesity drugs
Muscle-sparing obesity drug safe for Phase 3 trial, Veru says
The company is preparing a Phase 3 trial of enobosarm with a novel formulation that could extend its patent life.
By Jonathan Gardner • May 28, 2025 -
GSK-licensed antibiotic meets goal in late-stage study
The British drugmaker may have succeeded in reviving an oral antibiotic previously rejected by the FDA when it was under development at Spero.
By Kristin Jensen • May 28, 2025 -
Sponsored by Almac Clinical Services
[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care
Agile biopharma firms are driving breakthroughs. Learn how they ensure clinical trial success in this podcast.
By BioPharma Dive's studioID • May 28, 2025 -
ASCO25
Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer
Still, the therapies’ modest benefit as a maintenance therapy points to how better treatments are needed for small cell lung cancer, according to one physician.
By Jonathan Gardner • May 22, 2025 -
Sponsored by IQVIA Technologies
From insight to impact: How eCOAs strengthen trial data quality
Timely, high-integrity insights for sponsors that reduce risk and move trials forward.
By IQVIA • May 19, 2025 -
Women’s health faces growing headwinds, despite jump in venture investment
While venture funding is rising, federal policy upheaval may affect women’s health research more acutely than other fields, one biotech CEO said.
By Delilah Alvarado • May 13, 2025 -
iTeos, GSK to shelve TIGIT drug after study setback
The failure is the latest stumble for a cancer drug class that hasn’t lived up to expectations. iTeos will begin a strategic review in response.
By Ben Fidler • May 13, 2025 -
Pain drugs
Viatris’ new form of old pain drug scores in large trials
A version of meloxicam designed to work faster has beat out a placebo in two late-stage studies focused on post-surgical acute pain. Viatris now plans to file for approval this year.
By Jacob Bell • May 8, 2025 -
Retrieved from Vinay Prasad on May 08, 2025
Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.
CBER’s new chief has argued for more stringent measures of assessing drugs for cancer and rare diseases, suggesting he might push for higher standards in the review of medicines under his division's purview.
By Jonathan Gardner • May 8, 2025 -
AstraZeneca quietly exits neuroscience
The company removed experimental drugs for Alzheimer’s, migraine and pain from its pipeline to focus more resources on “core therapeutic areas” and “high value” programs.
By Jacob Bell • May 1, 2025 -
New Akeso, Summit data stir debate on PD-1/VEGF drugs
Interim results from a study in China suggest ivonescimab may reduce the risk of death versus Keytruda, but the difference wasn’t statistically significant.
By Ben Fidler • April 28, 2025 -
Bristol Myers’ prized schizophrenia drug stumbles in testing
A late-stage study found Cobenfy wasn’t better than a placebo as an add-on to atypical antipsychotics. Some analysts view the failure as a “significant hit” to the drug’s commercial outlook.
By Jacob Bell • April 23, 2025 -
Enhertu combo tops standard drugs in first-line HER2 breast cancer
The data could help the Enhertu regimen overtake a drug combination that’s been used as the initial treatment for HER2-positive breast tumors for more than a decade.
By Ben Fidler • April 21, 2025 -
Obesity drugs
Lilly’s obesity pill scores in large diabetes trial
The drug, orforglipron, helped people with diabetes reduce their blood sugar levels while spurring significant weight loss, swelling Lilly's market value by more than $100 billion.
By Jonathan Gardner • Updated April 21, 2025 -
New research kindles excitement around stem cell therapies for Parkinson’s
Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain, but also show promising — albeit unproven — signs of efficacy.
By Jacob Bell • April 16, 2025 -
Bristol Myers stumbles in bid to widen heart drug’s use
Camzyos’ failure in a form of hypertrophic cardiomyopathy dampened its commercial outlook and spurred debate as to whether other drugs like it would similarly struggle in testing.
By Ben Fidler • April 15, 2025 -
Obesity drugs
Safety worries spur Pfizer to drop another obesity pill
Signs of potential liver damage in a study participant led the company to abandon danuglipron, a drug it hoped would help it break into the highly lucrative market for obesity drugs.
By Jonathan Gardner • April 14, 2025 -
Gene editing
Verve’s second swing at gene editing for heart disease shows early promise
Wall Street analysts said the results for Verve’s therapy appeared competitive on efficacy, while avoiding any major safety concerns — at least so far.
By Ben Fidler • April 14, 2025