Clinical Trials: Page 2

Drug regulators in agreement on coronavirus vaccine trials, FDA official says

Health agencies will be under pressure to clear promising vaccines quickly. But Peter Marks, a top FDA official, said regulators will still want to see large trials to provide proof of safety.

By Jonathan Gardner , Ben Fidler • June 09, 2020

Deep Dive

The coronavirus vaccine frontrunners have emerged. Here's where they stand

Pfizer and BioNTech, which this week disclosed early Phase 1 study results, expect to be able to make 100 million doses of their vaccine by the end of the year and 1.2 billion doses in 2021.

By Nami Sumida • UPDATED: July 2, 2020 at 10:54 a.m.

AstraZeneca, already a leader in coronavirus vaccine race, steps up antibody drug work

The British drugmaker has licensed six potential COVID-19 antibodies from Vanderbilt, and could start testing the first of them by early August.

By Ben Fidler • June 09, 2020

Alnylam details data for kidney disease drug under FDA review

Treatment with lumasiran significantly lowered levels of a key chemical correlated with kidney failure, paving the way for what would be Alnylam's third drug approval.

By Jonathan Gardner • June 08, 2020

Lilly gets a 2nd COVID-19 antibody into clinical trials with Junshi's help

The trial start comes days after Lilly began U.S. testing of a similar drug it developed with AbCellera, putting the Indianapolis pharma at the forefront of efforts to engineer antibodies against the new coronavirus. 

By Ned Pagliarulo • June 08, 2020

Sarepta, with new data, plans final push for limb-girdle gene therapy

New results show a higher dose of Sarepta's gene therapy outperformed a lower one, a finding its CEO believes should build confidence in several of its other experimental treatments.

By Ben Fidler • June 08, 2020

Case for hydroxychloroquine in COVID-19 fades as key UK study finds no benefit

A large, controlled trial showed the repurposed malaria drug didn't help patients hospitalized with coronavirus disease any more than standard care. 

By Ned Pagliarulo • June 05, 2020

'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.