5 reasons life sciences needs better clinical trial supply management

A new industry consortium is lining up stakeholders to work together to address long-standing pain points that disrupt clinical trials.

Nov. 16, 2020

AstraZeneca cancer drug found ineffective for COVID-19

The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19.

By Kristin Jensen • Nov. 12, 2020

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

Moderna close to having results from key coronavirus vaccine trial

The fast-accelerating spread of coronavirus in the U.S. has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results.

By Ned Pagliarulo • Nov. 12, 2020

Pfizer, BioNTech's strong results give lift to other coronavirus vaccines

The companies' early success helps validate an industry-wide bet to target the coronavirus' spike protein. But differences between each vaccine could still prove crucial.

By Jonathan Gardner • Nov. 11, 2020

Pfizer and BioNTech's coronavirus vaccine works. Here's what we still don't know.

An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details.

By Ned Pagliarulo , Ben Fidler • Nov. 10, 2020

Amgen's asthma drug delivers a needed win

A late-stage study found Amgen's tezepelumab benefited a variety of patients with severe asthma, results that one analyst called a "best-case outcome."

By Jacob Bell • Nov. 10, 2020

Coronavirus vaccine from Pfizer, BioNTech prevents COVID-19, early results show

An early look at Pfizer and BioNTech's large coronavirus vaccine study found the companies' experimental shot more than 90% effective, an encouraging result that bodes well for others in development.

By Jonathan Gardner • Updated Nov. 9, 2020

Novartis rare disease drug, repurposed for COVID-19, fails in late-stage study

The Swiss drugmaker's COVID-19 research efforts now largely rest on the outcome of a recent alliance to develop oral medicines for the new coronavirus.

By Ben Fidler • Nov. 6, 2020

Gene therapy for Duchenne muscular dystrophy: nearing final tests

Sarepta and Pfizer are advancing their experimental treatments into late-stage trials, while others are accelerating research in what's become one of gene therapy's most active fields.

By Ben Fidler • Nov. 5, 2020

Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma

Results the company will present at a medical meeting, while early, don't appear to meet the high bar set by rival CAR-T cell therapies from Bristol Myers Squibb and Johnson & Johnson. 

By Ben Fidler • Nov. 4, 2020

Bristol Myers bet pays off as psoriasis drug beats Amgen rival in study

While full data were not disclosed, the trial's outcome signals competition for Amgen's Otezla, which Celgene was forced to divest last year as a result of its acquisition by Bristol Myers.

By Ned Pagliarulo • Nov. 3, 2020

AstraZeneca partners with Fusion to test radiopharmaceuticals in cancer

While small in size, the collaboration gives AstraZeneca an entry point into radiopharmaceutical drug research, which was the focus of two Novartis buyouts in recent years.

By Ned Pagliarulo • Nov. 2, 2020

Safety concerns lead Regeneron to halt testing of COVID-19 drug in some patients

A study monitoring board flagged a "potential safety signal" in some hospitalized COVID-19 patients who require breathing support, telling the biotech to modify its study protocol.

By Ben Fidler • Oct. 30, 2020

Lilly antibody drug doesn't help hospitalized COVID-19 patients in NIH study

The results could raise doubts about the ability of synthetic antibody drugs to help patients already very sick with COVID-19.

By Ben Fidler • Updated Oct. 27, 2020

Identifying and recruiting patients into rare disease clinical trials: A multi-pronged and customized approach

Learn about strategies for identifying and recruiting rare disease patients. 

By Sarah Glass, Ph.D., Shipra Patel, M.D., & Altair Silva, Parexel • Oct. 27, 2020

Mirati cancer drug results spark hopes of outperforming Amgen's

The biotech's KRAS-blocking pill trails Amgen's sotorasib in development, but early data suggest it might match the bar set by Amgen.

By Jonathan Gardner • Oct. 26, 2020

AstraZeneca, J&J cleared to restart major coronavirus vaccine studies

The U.S. trial of AstraZeneca's shot has been paused over safety concerns since early September, while J&J's was halted in mid-October. 

By Ned Pagliarulo • Updated Oct. 24, 2020

At key meeting, FDA advisors debate if early coronavirus vaccine approvals may compromise trials

An emergency clearance is expected for the first vaccine proven effective. But early availability of a shot could jeopardize ongoing studies, and may make tests of other candidates more difficult.

By Ned Pagliarulo • Oct. 23, 2020

Moderna enrolls final volunteers into key coronavirus vaccine study

Recruiting 30,000 participants for the late-stage trial took Moderna just three months, even after the company slowed enrollment to boost participation of people of color. 

By Ned Pagliarulo • Oct. 22, 2020

CRISPR Therapeutics reports remissions, one death in cancer cell therapy study

The biotech is one of several attempting to develop "off-the-shelf "CAR-T therapies. While trial results show potential, high-dose treatment was paused following a patient's death.

By Jonathan Gardner • Oct. 21, 2020

Merck, with more study data, builds case for pneumonia vaccine successor

Results from two Phase 3 studies showed Merck's candidate to be similarly immunogenic as Pfizer's Prevnar 13, lending additional strength to Merck's plans to ask for U.S. approval.

By Ned Pagliarulo • Oct. 20, 2020

Coronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come

The co-leader of an NIH network of coronavirus prevention studies spoke with BioPharma Dive about the FDA's big vaccine meeting this week and what will come next.

By Ben Fidler • Oct. 20, 2020

Early signs of survival benefit raise optimism around a small biotech's ALS drug

Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't.

By Jacob Bell • Oct. 16, 2020

Gilead's COVID-19 drug doesn't prevent deaths, large WHO study finds

The results could weaken the case for widely using Veklury, also known as remdesivir, just as the company is asking for full approval from the FDA. 

By Ned Pagliarulo • Oct. 16, 2020

Pfizer won't seek FDA clearance of coronavirus vaccine until mid-November, CEO says

An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election. 

By Ben Fidler • Oct. 16, 2020