Seagen trial data impresses at ESMO, lifting Merck, Pfizer in the process

A combination of Seagen and Astellas’ antibody-drug conjugate Padcev with Merck’s Keytruda dramatically improved survival in first-line bladder cancer.

By Ned Pagliarulo • Oct. 23, 2023

Verve gets FDA green light to run base editing study in US

The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.

By Ned Pagliarulo • Oct. 23, 2023

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

Why the evolution of patient advocacy organizations means better data for your rare disease trial

Rare disease drug development is a unique and challenging field that demands strategic development expertise and uniting of the various stakeholders working toward the same goal.

Oct. 23, 2023

Landing a CRO that’s an extension of your team

In an industry where the convergence of cutting-edge science and a human-centered approach is equally imperative, Worldwide Clinical Trials has found the sweet spot, delivering excellence in the clinical trial experience.

Oct. 16, 2023

5 steps to help increase the odds of clinical trial success

There are many common reasons clinical trials fail, including failure to demonstrate efficacy, safety concerns, issues with inclusion and exclusion criteria and patient recruitment. Follow these five steps to increase the odds of clinical trial success.

Oct. 16, 2023

PepGen cleared by FDA to begin study of muscular dystrophy drug

The company expects to deliver first results next year from the early-stage study of people with myotonic dystrophy type 1.

By Kristin Jensen • Oct. 12, 2023

Novo Nordisk’s Ozempic shows kidney benefit in large study

The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.

By Jonathan Gardner • Oct. 11, 2023

Merck data show survival benefit to early Keytruda treatment

In the perioperative setting, Merck says its immunotherapy helps patients live longer. An approval decision is expected later this month.

By Jonathan Gardner • Oct. 10, 2023

Akero drug for NASH misses goal in mid-stage study

The biotech claimed the results still showed promise for its experimental fatty liver disease treatment, but shares sank sharply on the news.

By Ned Pagliarulo • Oct. 10, 2023

NIH funds research for three experimental ALS drugs

The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

By Jacob Bell • Oct. 6, 2023

FDA panel finds KRAS drug data unreliable, in blow to Amgen

The negative panel vote likely means Amgen will need more data to support a full approval for its conditionally cleared lung cancer drug Lumakras.

By Ned Pagliarulo • Updated Oct. 6, 2023

Moderna claims positive results in early study for combo COVID, flu shot

The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.

By Delilah Alvarado • Oct. 4, 2023

Novartis’ closely watched rare disease drug scores in kidney disorder

Called iptacopan, the experimental medicine has now scored positive results in three late-stage clinical trials, the latest in an uncommon kidney disorder known as IgA nephropathy.

By Jacob Bell • Oct. 2, 2023

Structure boosted by early data for experimental obesity drug

Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug, reflecting investor enthusiasm for the weight loss medicines. 

By Ned Pagliarulo • Sept. 29, 2023

J&J cancer drug combo beats Tagrisso in closely watched trial

Interim results from a study called “Mariposa” found that a regimen of two J&J medicines improved progression-free survival versus AstraZeneca’s widely used therapy.

By Ned Pagliarulo • Sept. 28, 2023

BrainStorm’s ALS therapy not effective, FDA panel finds

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment to be effective for treating ALS. 

By Ned Pagliarulo • Updated Sept. 28, 2023

Immunovant data show potential for autoimmune disease drug

Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.

By Ned Pagliarulo • Sept. 26, 2023

Novartis radiopharmaceutical drug succeeds in first-line gut cancer study

Novartis has made a large investment in targeted radiotherapies, sparking competition from fellow pharma companies and young biotechs.

By Jonathan Gardner • Sept. 25, 2023

AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors

Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.

By Jonathan Gardner • Sept. 22, 2023

Seagen’s cancer drug succeeds in ‘must-win’ trial

Compared to chemotherapy, a combination of Seagen’s Padcev and Merck’s Keytruda was significantly better at keeping bladder cancer patients alive longer and their disease from progressing.

By Jacob Bell • Sept. 22, 2023

Latest trial win supports expanded use of Bristol Myers’ Opdivo in lung cancer

The drug, which is already cleared as a neoadjuvant lung cancer treatment, could better compete with Merck’s Keytruda if it gains approval in the adjuvant setting for non-small cell tumors.

By Delilah Alvarado • Sept. 22, 2023

FDA panel backs Alnylam drug despite doubts over benefit

“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

By Jonathan Gardner • Updated Sept. 14, 2023

After IPO success, Acelyrin hits trial setback with inflammation drug

Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

By Kristin Jensen • Sept. 12, 2023

Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

By Jonathan Gardner • Sept. 11, 2023

In advocates’ push for superbug funding, ‘$6 billion is nothing’

The PASTEUR Act could be heading for another setback, but advocates say they see a future for funding research into antimicrobial resistance.

By Karissa Waddick • Sept. 8, 2023