Bayer’s experimental blood-thinner notches trial win in stroke prevention

Asundexian's Phase 3 study results raise hopes for a new class of cardiovascular drugs that has seen clinical setbacks.

By Jonathan Gardner • Nov. 24, 2025

Novo Nordisk’s GLP-1 misses goal in closely watched Alzheimer’s studies

The studies offer perhaps the most concrete rebuttal yet to an idea that GLP-1 drugs, which have profound benefits on weight loss and heart health, might also help combat neurodegeneration.

By Jacob Bell • Nov. 24, 2025

Explore the Trendline➔

Neuroscience 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

A brain biotech’s top drug fails against MS

Shares of Contineum Therapeutics dipped by the double-digits late Thursday after investors learned of a clinical setback for a drug that’s also piqued Johnson & Johnson’s interest.

By Jacob Bell • Nov. 21, 2025

Agios shares fall on mixed sickle cell results for blood disease drug

Pyrukynd, which Agios sells for a rare type of anemia, missed one of its main objectives in a study seen as crucial for its commercial outlook and the company’s reinvention as a rare disease specialist.

By Jonathan Gardner • Nov. 19, 2025

Roche pill notches win in early breast cancer

Roche claimed the results make its drug giredestrant the first of its kind, a so-called oral SERD, to show a benefit in the “adjuvant” setting after surgery. 

By Jonathan Gardner • Nov. 18, 2025

The inspection-ready operating model for clinical trials

Turn readiness into routine with roles, controls and audit trails across systems.

By IQVIA Technologies • Nov. 17, 2025

Bristol Myers, J&J’s new blood thinner fails first big test

Milvexian’s failure in acute coronary syndrome dampens the outlook for other anticoagulants like it and is the latest in a series of clinical setbacks this year for Bristol Myers.

By Jonathan Gardner • Nov. 14, 2025

Korro to cut staff, shift strategy as RNA editing drug misses mark in early testing

Korro’s lead program for alpha-1 antitrypsin deficiency wasn’t as potent as anticipated, leading the company to change course and lay off a third of its workforce.

By Kristin Jensen • Nov. 13, 2025

Novartis, with study success, to seek approval of new kind of malaria drug

The treatment — which could be the first novel antimalarial in decades — showed the ability in testing to combat drug resistance and slow disease transmission.

By Delilah Alvarado • Nov. 12, 2025

Neurocrine chalks up a depression drug failure

Analysts suspected that the mid-stage trial miss wouldn't ding Neurocrine’s share price since expectations around the program were "near-zero."

By Jacob Bell • Nov. 10, 2025

Roche’s MS tablet scores in late-stage studies

The drug appears effective against both “relapsing” and “primary progressive” forms of the disease, though some analysts question if Roche has collected enough data to ask for approval in the latter.

By Jacob Bell • Nov. 10, 2025

Merck showcases data suggesting PCSK9 pill might rival cholesterol-lowering shots

Merck’s pill, which could be the first oral PCSK9 drug to get to market, displayed similar effects on lipid levels as injectable medicines from Amgen and Regeneron.

By Jonathan Gardner • Updated Nov. 10, 2025

Pharma’s clinical trial diversity push faces a new threat

Skyrocketing healthcare costs could deliver another blow to the industry’s ongoing quest to boost representation in R&D.

By Meagan Parrish • Nov. 7, 2025

Sarepta Duchenne drugs come up short in confirmatory test

Still, CEO Doug Ingram claimed removing the two drugs, Vyondys 53 and Amondys 45, from market would make “little sense” and that the evidence accrued to date makes a strong case for full approval.

By Ben Fidler • Nov. 4, 2025

Caribou results suggest renewed promise for ‘off-the-shelf’ cancer cell therapy

While early, the data support Caribou’s plan to boost its therapies’ effectiveness by using donor cells that are carefully matched to a patient’s immune system. 

By Jonathan Gardner • Nov. 3, 2025

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

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

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

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

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