Clinical Trials

'Warp Speed' push for coronavirus vaccine accelerates as White House reportedly narrows field

The U.S. government aims to have a vaccine ready by the end of this year or early next, and appears to be counting on large drugmakers like J&J, Pfizer and Merck to deliver on that highly ambitious goal.

By Ned Pagliarulo • June 04, 2020

Hydroxychloroquine offers no COVID-19 protection after exposure, study shows

Results from a closely watched University of Minnesota trial cast more doubt on the repurposed malaria drug's potential to prevent COVID-19. But the study's limitations mean it's likely not the final word. 

By Jonathan Gardner , Ned Pagliarulo • June 03, 2020

COVID-19 studies of malaria, blood pressure pills come under scrutiny

The Lancet and The New England Journal of Medicine issued "statements of concern" regarding two high-profile trials they published, citing gaps in a database used by the authors.

By Jonathan Gardner • UPDATED: June 4, 2020 at 4:27 p.m.

Bristol Myers follows Zeposia launch with positive data from key study

The drugmaker's new pill would be the only drug in its class to treat ulcerative colitis, but could face competition from Pfizer, AbbVie and Gilead.

By Jonathan Gardner • June 02, 2020

Sponsored by PRA Health Sciences

Challenges arise as the need for pediatric studies increases

Pediatric clinical research poses more challenges around enrollment, costs, and trial design.

Eli Lilly starts first-ever trial of a COVID-19 antibody drug, speeding past rivals

The Indianapolis pharma has quickly moved into human tests of an antibody it's developing with private biotech AbCellera. Initial data are expected before July.

By Ben Fidler • June 01, 2020

COVID-19 could slow progress in reducing cancer death, NCI head warns

American Society of Clinical Oncology meeting attendees were warned of the impact that pandemic-driven delays in diagnosis and therapy could have on cancer patients. 

By Ned Pagliarulo • June 01, 2020

Details lacking, but new remdesivir data point to a benefit for 'moderate' COVID-19 patients

The results suggest that Gilead's drug may help a broader swath of patients with coronavirus disease, though the magnitude of benefit is unclear. 

By Jacob Bell • June 01, 2020

Q&A

How Merck seeks to catch up in the coronavirus drug race

The pharmaceutical giant just became a major player in the global push to develop medicines against COVID-19. Daria Hazuda, vice president of infectious disease discovery, spoke with BioPharma Dive about its plans. 

By Ben Fidler • June 01, 2020

With new Allogene data, same promise, questions surround 'off the shelf' CAR-T

Updated results from Allogene at ASCO's virtual meeting are encouraging, but still don't show whether its allogeneic approach can match autologous CAR-T.

By Ben Fidler • May 29, 2020

AstraZeneca bid to expand lung cancer drug's use boosted by trial data

The ADAURA trial — stopped two years ahead of schedule — showed Tagrisso kept early-stage lung cancer patients from relapsing longer than did placebo.

By Jonathan Gardner • UPDATED: May 29, 2020 at 1:11 p.m.

Coronavirus vaccine developers plan to enroll tens of thousands in late-stage tests

As initial studies get underway in small groups of volunteers, companies like Pfizer, AstraZeneca and J&J are preparing for large Phase 3 trials.

By Ned Pagliarulo • May 28, 2020

Novartis teams with Mass. Eye & Ear to join coronavirus vaccine chase

The Swiss pharma has become the latest large drugmaker to enter the worldwide race to develop a vaccine for COVID-19, tapping a project developed by gene therapy experts at the Massachusetts Eye and Ear Hospital.

By Jonathan Gardner • May 28, 2020

Novavax buys more manufacturing capacity as first COVID-19 vaccine test begins

The Maryland biopharma has acquired a Czech vaccine developer for $167 million, gaining a facility in Europe that will boost its COVID-19 vaccine production capabilities.   

By Kristin Jensen • May 28, 2020

U.K. grants early access to Gilead's remdesivir for COVID-19 patients

Supplies of the antiviral drug are tight, however, with many of the doses donated by Gilead reserved for use in the U.S. 

By Kristin Jensen • May 27, 2020

Merck makes COVID-19 drug plans clear with flurry of deals

The drugmaker, which for months appeared to be watching the pandemic from the sidelines, will advance two coronavirus vaccine candidates, as well as an oral antiviral drug. 

By Ned Pagliarulo , Ben Fidler • May 26, 2020

New study details show remdesivir speeds COVID-19 recovery, but doesn't help sickest patients

Much anticipated results from an NIH-led trial of Gilead's antiviral drug were published Friday in the New England Journal of Medicine.

By Ned Pagliarulo • UPDATED: May 25, 2020 at 11:05 a.m.

Coronavirus study in China shows CanSino's vaccine spurs immune responses

But researchers, who conducted the trial in a locked-down Wuhan, aren't yet certain whether those responses will actually confer protection against coronavirus infection.

By Ned Pagliarulo • UPDATED: May 22, 2020 at 3:13 p.m.

Intercept shares fall as FDA again delays closely watched NASH drug

The FDA has asked for more data on obeticholic acid, which could be the first-ever marketed medicine for non-alcoholic steatohepatitis. The latest delay means the drug likely won’t be approved by the agency's June 26 deadline.

By Jonathan Gardner • May 22, 2020

High expectations cast a shadow over Gilead and Galapagos' positive data

Filgotinib, a drug crucial to the companies' partnership, beat out placebo in a ulcerative colitis study. But lackluster results from a low dose could dim its competitive prospects.

By Jacob Bell • May 21, 2020

More questions than answers as Moderna's coronavirus vaccine speeds ahead

Preliminary results from a Phase 1 study were enough to add $5 billion to Moderna's market capitalization. But they don't answer key questions about the vaccine's safety and effectiveness. 

By Jonathan Gardner • May 19, 2020

Sponsored by PSI CRO

Leadership in crisis: How pharmaceutical industry leaders guide their teams while keeping clinical trials moving forward

Brenda Reese, head of North American business development for PSI CRO, discusses what's required of today's life sciences leaders.

Moderna delivers first human data for a coronavirus vaccine

The first volunteers who received low or medium doses of Moderna's vaccine produced what look to be meaningful immune responses, but it's unclear whether that will lead to disease prevention.

By Ben Fidler • May 18, 2020

Safety questions linger as Pfizer preps Duchenne gene therapy for final test

New data presented at the American Society of Gene & Cell Therapy's yearly meeting show promise, but also side effects that haven't been seen with a rival treatment from Sarepta.

By Ben Fidler • May 15, 2020

Ousted BARDA director: Hydroxychloroquine push distracted government scientists

Safety concerns led to a clash over how widely to distribute the malaria pill for use against COVID-19, Rick Bright testified to Congress Thursday. 

By Jonathan Gardner • May 14, 2020