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

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

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

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

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

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

FDA plans to phase out animal testing for some drugs

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.

By Ned Pagliarulo • April 11, 2025

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

Amid a funding drought for startups, the company is looking for a deal that can advance its liver cancer drug.

By Jonathan Gardner • April 10, 2025

Rallybio discontinues lead drug for rare maternal disorder

The company has decided to switch gears following disappointing data for a monoclonal antibody targeting a rare maternal blood disorder.

By Delilah Alvarado • April 8, 2025

Lilly study data reinforce potential of new kind of heart drug

Drugs from Novartis, Amgen and now Lilly have proven powerfully effective at reducing Lp(a). Whether that will translate to a cardioprotective benefit won’t be answered until Phase 3 tests read out.

By Ned Pagliarulo • March 31, 2025

Wave to seek approval of Duchenne drug after mid-stage study data

The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.

By Kristin Jensen • March 26, 2025

Merck bets $200M on a new type of heart pill

A licensing deal with Jiangsu Hengrui Pharmaceuticals puts Merck in a competitive race to develop a medicine that targets a genetic risk factor called lipoprotein(a). 

By Jonathan Gardner • March 25, 2025

Novo adds to obesity drug pipeline via $200M deal with China-based biotech

The licensing pact adds a second so-called "triple agonist" to the Danish drugmaker's portfolio as competition with Lilly and other contenders heats up.

By Jonathan Gardner • March 24, 2025

Accelerate oncology drug development: A data-driven approach to clinical decisions

Speed vs. success in oncology trials: Discover data-driven strategies to accelerate drug development.

March 24, 2025

Academic medical centers say funding cuts jeopardize health research

Proposed cuts to National Institutes of Health funding threaten innovation necessary to fuel advances in patient care, researchers and provider groups say.

By Susanna Vogel • March 21, 2025

Novartis builds case for new SMA gene therapy

To Novartis, fresh late-stage data support the idea that its intrathecal drug, which has the same active ingredient as Zolgensma, could be approved for a broad range of spinal muscular atrophy patients.

By Jacob Bell • March 20, 2025

Immunovant claims study success for immune disease drug but holds off on submission

The company continues to focus on a next-generation drug while batoclimab’s testing in thyroid eye disease wraps up.

By Kristin Jensen • March 19, 2025

Prime sets sights on liver, lung disease as next target for its gene editing tech

The biotech unveiled a new research program in alpha-1 antitrypsin deficiency, a disease that’s also a focus for rival Beam Therapeutics.

By Ned Pagliarulo • March 18, 2025

Orca Bio to seek approval of T cell transplant after positive trial data

Results showed Orca’s treatment, a purified mix of donor-derived T cells and stem cells, was safer than standard transplant in treating certain blood cancers.

By Ned Pagliarulo • March 17, 2025

Arvinas gets positive breast cancer data, but finds differentiation a hard sell

Trial results show vepdegestrant, a protein-degrading drug Arvinas is developing with Pfizer, improved on fulvestrant in a subgroup of breast cancer patients, but not the overall study population.

By Ned Pagliarulo • March 11, 2025

Novo’s Wegovy successor disappoints in second large trial

A study in people with obesity and diabetes again found CagriSema helps people lose weight, but not by enough to clearly surpass Eli Lilly’s Zepbound.

By Jonathan Gardner • March 10, 2025

Mineralys shares climb on study data for blood pressure drug

Findings from a pair of studies in tough-to-treat hypertension establish Mineralys’ drug as a “derisked, almost-commercial stage cardiometabolic asset,” wrote one analyst firm following the company.

By Ben Fidler • March 10, 2025

J&J scraps depression testing for potential blockbuster drug

Analysts say the decision is a “big blow” to a once-promising class of brain therapies that include’s J&J’s aticaprant and a drug from Neumora.

By Jacob Bell • March 7, 2025