Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug

The Swiss drugmaker said it was “encouraged” by the signs of effectiveness of the drug, developed by biotech Prothena, showed in two earlier studies that missed their main goals.

By Jonathan Gardner • June 16, 2025

Novo, searching for a spark, plans late-stage trials for amylin drug

The Danish drugmaker, which is grappling with a share decline and competition from Eli Lilly, unveiled planned trials of an obesity medication that works differently than its popular Wegovy. 

By Jonathan Gardner • June 13, 2025

Explore the Trendline➔

Oncology'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

NewAmsterdam says cholesterol drug may also combat Alzheimer’s

A "sub-study" of a large clinical trial found the drug, obicetrapib, significantly reduced levels of a type of tau protein linked to Alzheimer's development.

By Jacob Bell • June 9, 2025

Metsera shares climb on early data for amylin-targeting obesity shot

Early-stage study results suggest that a single shot of the company’s therapy, which works differently than GLP-1 medicines, might have effects that last at least four weeks.

By Jonathan Gardner • Updated June 9, 2025

Merck claims study success with PCSK9 cholesterol pill

Enlicitide, which could be the first oral medication that blocks the protein PCSK9, helped cut cholesterol levels in a pair of closely watched trials.

By Ben Fidler • June 9, 2025

The risk plan you forgot about: 3 considerations for your recruitment and enrollment strategy

It’s a truth that all clinical teams are aware of: risk mitigation is a core part of clinical trial success. But, what does that mean for your enrollment plan?

June 9, 2025

The golden era of GLP-1 drugs: How will it impact medicine and society?

GLP-1 drugs are transforming medicine, but what are the medical and societal ripple effects?

By Dr. Gaetano Morelli, MD, Chief Medical Officer and Executive Vice President Medical Affairs at Altasciences • June 9, 2025

Bispecific cancer drugs, data caveats and funding alarms: 3 takeaways from ASCO

Breast cancer study results impressed at this year’s meeting, but raised new questions. Doctors also wrestled with how best to use new bispecific antibodies, and expressed concern about looming cuts to science funding.

By Delilah Alvarado , Jonathan Gardner , Ned Pagliarulo • June 4, 2025

Bayer drug could ease side effects of common breast cancer treatment, detailed data show

Elinzanetant proved effective for managing disruptive vasomotor symptoms in women on endocrine therapy, supporting a Bayer application for approval.

By Delilah Alvarado • June 3, 2025

J&J data support earlier use of combo pill in prostate cancer

According to J&J, Akeega is the first PARP inhibitor combination that’s proven effective treating earlier-stage prostate tumors that harbor mutations in genes beyond BRCA.

By Jonathan Gardner • June 3, 2025

Bispecific competition, debating oral SERDs and a bold GLP-1 prediction

Antibody drugs that target the PD-1 and VEGF pathways are in the ASCO spotlight, while doctors wrestle with how to use new breast cancer medicines.

By Delilah Alvarado , Jonathan Gardner , Ned Pagliarulo • June 2, 2025

Vera drug scores in closely watched study in rare kidney disease

Phase 3 results revealed Monday led shares to surge and should yield an approval application in IgA nephropathy, a competitive corner of drug research, later this year. 

By Ben Fidler • June 2, 2025

Enhertu potential broadens as new data point to frontline breast cancer role

Study results unveiled at ASCO show combining Enhertu with Perjeta can significantly delay tumor growth versus a regimen that's been standard treatment for more than a decade.

By Ned Pagliarulo • June 2, 2025

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

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

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

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

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

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

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

[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

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

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