Bayer ends large blood thinner trial for ‘inferior efficacy’

Company shares fell after study monitors called for halting a planned 18,000-person trial because Bayer’s drug wasn’t working as well as Eliquis.

By Jonathan Gardner • Updated Nov. 20, 2023

Biohaven hopes to muscle in on Ozempic with a different type of weight loss drug

Several biotech companies, Biohaven among them, are trying to develop medicines that could trim the waistline while building lean tissue.

By Kelly Bilodeau • Nov. 20, 2023

Explore the Trendline➔

Immunology

Promising new mechanisms of action are driving significant pharmaceutical company investment into drugs for immune diseases like psoriasis and Crohn’s.

By BioPharma Dive staff

Paper details Astellas gene therapy study that led to patient deaths

The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.

By Kristin Jensen • Nov. 16, 2023

Anthos blood thinner bests Xarelto on safety in mid-stage study

Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.

By Ned Pagliarulo • Updated Nov. 14, 2023

Real-world evidence in pharmaceutical drug development – faster, safer and more relevant?

Regulatory agencies have set the framework and use cases for RWE. How can these increase the probability of success or efficiency in a pre-clinical and clinical drug development program?

By Lutz Schlicht, PhD, Target RWE • Nov. 13, 2023

3 ways decentralized clinical trials could help advance research on rare diseases

Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.

Nov. 13, 2023

First look at Verve study data offers base editing ‘proof of principle’

Early clinical trial results showed Verve’s therapy can substantially lower bad cholesterol. Still, investors sent the biotech’s shares down by 40% Monday.

By Ned Pagliarulo • Nov. 12, 2023

Detailed trial data confirm Wegovy heart benefit

As GLP-1 drugs for weight loss take off, the results for Novo Nordisk’s treatment could help convince insurers to expand coverage.

By Jonathan Gardner • Nov. 11, 2023

Atara’s cell therapy approach to MS falls short in study

Shares in the biotech tumbled by 75% as results from a Phase 2 trial showed more improvement in participants given a placebo.

By Kristin Jensen • Nov. 9, 2023

Celldex’s reinvention advances with inflammatory disease drug data

Shares in the biotech jumped higher Monday on positive results for the company's drug barzolvolimab in two chronic itching conditions.

By Ned Pagliarulo • Nov. 6, 2023

Sarepta gene therapy for Duchenne misses main goal of key study

Results from the EMBARK study, which were meant to confirm the approval of Sarepta's Elevidys, sent the company's shares down more than 40% Tuesday.

By Ned Pagliarulo • Updated Oct. 31, 2023

Novartis bet on kidney disease drug yields positive study data

The pharma paid more than $3 billion this summer to acquire Chinook Therapeutics and a therapy that just met its goal in a Phase 3 trial.

By Ned Pagliarulo • Oct. 30, 2023

Pfizer, BioNTech say combo flu, COVID shot met goal in study

The partners announced the trial had succeeded weeks after Moderna disclosed positive results from a study of its similar combination vaccine.

By Kristin Jensen • Oct. 26, 2023

Eisai says new data could support more convenient form of Alzheimer’s drug Leqembi

An under-the-skin injection of Leqembi performed about the same as the already marketed intravenous form, according to trial results presented Wednesday. A new approval application is expected by the end of March.

By Jacob Bell • Updated Oct. 26, 2023

Excision gives first look at gene editing therapy for HIV

The study results, while only from three participants, offer a glimpse at how one of the few in vivo CRISPR therapies in U.S. human testing is working. 

By Ned Pagliarulo • Oct. 25, 2023

Patient groups have become influential in drug R&D. Here’s a look at their impact.

“They have the money” and they’re using it to influence drug development, according to the director of the IQVIA Institute for Human Data Science.

By Kelly Bilodeau • Oct. 25, 2023

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

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

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

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

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