Clinical Trials

With first results, Novavax takes step forward in coronavirus vaccine race

Early-stage results appear to show that Novavax's shot passed its first meaningful test, helping the Maryland biotech keep pace with larger competitors.

By Ben Fidler • Aug. 04, 2020

Novartis says CAR-T cancer therapy works in second lymphoma type

Early results from a trial testing Kymriah in follicular lymphoma were reportedly positive, supporting the pharma's plans to ask for another approval.

By Ned Pagliarulo • Aug. 04, 2020

Sponsored by WCG

COVID-19 changed everything: Now contracts and budgets need to catch up

As the pandemic continues, we see teams will be recalibrating everything, especially study budgets.

Big pharma alliance recruits first patients for unusual COVID-19 study

The trial is testing whether drugs from Amgen, Takeda and AbbVie can combat the life-threatening immune overreaction some COVID-19 patients experience.

By Jacob Bell • Aug. 03, 2020

Lilly to test COVID-19 antibody drug in unorthodox nursing home study

Seeking fast answers in a pandemic, Lilly will use mobile RVs to set up infusion clinics at assisted living facilities, which have become COVID-19 hot spots. 

By Ben Fidler • Aug. 03, 2020

Merck nears clinical tests for coronavirus vaccine candidates

Two candidates recently acquired in deals with IAVI and Themis have shown promise in preclinical studies, Merck executives said, and Phase 1 trials will begin later this year.

By Ned Pagliarulo • July 31, 2020

US promises $2.1B to Sanofi, GSK in latest coronavirus vaccine deal

The contract is the largest yet from the Trump administration's Operation Warp Speed, although Sanofi and GSK have yet to begin clinical testing of their shot.

By Ned Pagliarulo • July 31, 2020

AstraZeneca signals it won't wait for US data to seek clearance of coronavirus vaccine

The British drugmaker indicated on a conference call that data from trials already underway in the U.K., Brazil and South Africa will be sufficient to ask regulators to approve the vaccine.  

By Jonathan Gardner • July 30, 2020

J&J, beginning first human trial, aims for a 1-shot coronavirus vaccine

Preclinical data published Thursday suggest one dose of J&J's vaccine could protect against coronavirus disease, but that goal has proved difficult for drugmakers so far.

By Ben Fidler • July 30, 2020

A Roche arthritis drug fails in COVID-19, casting doubt on a strained hypothesis

Negative results for Actemra follow setbacks for Kevzara, which works similarly, and further weaken the case that the drugs could help treat severe COVID-19.

By Ben Fidler • July 29, 2020

BioNTech, Pfizer pick a surprise coronavirus vaccine, follow Moderna into late-stage test

After testing four variations of their vaccine, the companies chose a different version for Phase 3 than the one previously thought to be most advanced.

By Ben Fidler • UPDATED: July 28, 2020 at 11:54 a.m.

Moderna secures almost $500M more as it starts first large-scale US study of coronavirus vaccine

Moderna went from designing a vaccine to a Phase 3 trial in historic time. Now the biotech will test whether its shot can truly help stop coronavirus' spread.

By Ben Fidler • July 27, 2020

Sponsored by Yourway

Facilitating human clinical trials during and after COVID

Several centralized studies are being converted into decentralized/virtual studies to afford patients the ability to receive treatment at home.

On eve of first big coronavirus vaccine study, trial leaders brace for 'unprecedented' task

Researchers will need millions of volunteers to find the roughly 150,000 required for the five Phase 3 trials expected this year. Here's what lies ahead for them.

By Ben Fidler • July 24, 2020

Early coronavirus vaccine data leave many questions, but some lessons, too

More is unknown than known about the four candidates for which early results have been disclosed. But the data provide a yardstick for assessing what comes next.

By Ned Pagliarulo • July 23, 2020

Coronavirus vaccine developers make case to Congress they can win public's trust

While developing a safe and effective vaccine remains the chief challenge, lawmakers grilled pharma officials on how any successful shot would be fairly priced and distributed.

By Ben Fidler • July 21, 2020

Biogen to study use of key SMA drug after Novartis gene therapy

A planned trial is meant to test whether Spinraza can further help infants and young children who have already received Zolgensma, which, in theory, is meant to be curative if given very early on.

By Ned Pagliarulo • July 21, 2020

CanSino coronavirus vaccine clears mid-stage test, but data show its limits

More than half of participants in the Phase 2 study had pre-existing immunity to the cold virus CanSino uses for its shot, weakening the vaccine's effects.

By Ned Pagliarulo • July 20, 2020

Pfizer and BioNTech coronavirus vaccine gets boost from German data

As the race to bring a vaccine to market accelerates, the companies unveiled new clinical results and a deal that promises the U.K. 30 million doses of a successful shot.

By Jonathan Gardner • July 20, 2020

Oxford coronavirus vaccine spurs immune responses, appears safe on first look

The vaccine, from the University of Oxford and AstraZeneca, is backed with more funding from governments and non-profit groups than any other in development.

By Ben Fidler • July 20, 2020

New data from MeiraGTx help bolster J&J's gene therapy bet

The results are the first from a slate of gene therapies J&J licensed from Meira last year, a deal that remains the pharma's largest investment in the field.

By Ben Fidler • July 17, 2020

J&J, on the cusp of starting coronavirus vaccine trials, sets high bar for success

On a second quarter earnings call, J&J's top scientist said he expects the company's vaccine to significantly surpass the effectiveness standard set out by the FDA.

By Ned Pagliarulo • July 16, 2020

Researchers publish long-awaited study data on Moderna coronavirus vaccine

The results support the biotech's earlier claim of positive results, but don't show whether the vaccine protects against infection. Still, "we're so hungry for a vaccine we're trying to read the tea leaves," said vaccine expert Paul Offit.

By Ned Pagliarulo • UPDATED: July 14, 2020 at 6:33 p.m.

Preventive studies for Eisai, Biogen Alzheimer's drug could add years to amyloid debate

Two late-stage trials will assess the companies' experimental drug BAN2401 in people without Alzheimer's symptoms but with biological signs of the disease.

By Jonathan Gardner • July 14, 2020

Sanofi turns to MD Anderson to help fuel cancer drug push

The French pharma is counting on a five-year alliance with the cancer center to speed its early oncology research, a renewed focus under CEO Paul Hudson. 

By Ned Pagliarulo • July 14, 2020