Clinical Trials: Page
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How Merck's 'puzzling' results could impact immunotherapy's role in early lung cancer
New study data add to evidence that checkpoint inhibitors can slow the return of lung tumors. But the results also leave doubt over how best to use the drugs.
By Ben Fidler • March 17, 2022 -
Courtesy of Eli Lilly
With trial success in kidney disease, Lilly, Boehringer make case for broader use of diabetes drug
The positive results are the latest evidence supporting a broader role for so-called SGLT2 inhibitors, which started out as diabetes medicines but have since shown promise in a range of metabolic diseases.
By Jonathan Gardner • March 16, 2022 -
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TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
Elizabeth Regan/BioPharma Dive
BridgeBio looks for comeback with trial results for muscular dystrophy drug
Positive signs for the experimental treatment could help shore up investor confidence in BridgeBio after the December study failure of a drug for a rare heart condition.
By Jonathan Gardner • March 14, 2022 -
Nektar, Bristol Myers drug combination fails in late-stage melanoma trial
The trial results were the most significant setback for the companies' four-year-old partnership and will likely force Nektar to cut costs.
By Ned Pagliarulo • March 14, 2022 -
Courtesy of Sanofi
Sanofi, with positive data in hand, to ask for approval of longer-lasting hemophilia therapy
Patients with severe hemophilia A who were given the drug had, on average, less than one bleeding event over a year, results that Sanofi and partner Sobi believe will pass muster with regulators.
By Jacob Bell • March 9, 2022 -
Dan Kitwood via Getty Images
Pfizer to test COVID pill in children as vaccinations in US plateau
Supplies of the drug, called Paxlovid, have become more available for adults in the U.S., which recently began rolling out a "test-to-treat" initiative likely to make use of Pfizer's pill.
By Kristin Jensen • March 9, 2022 -
Bluebird's CFO resigns as cash woes raise doubts about its future
The gene therapy developer's top financial executive, Gina Consylman, is stepping down amid concerns the company needs to raise additional cash to survive for more than a year.
By Jonathan Gardner • March 7, 2022 -
Permission granted by Gilead Sciences
Gilead says breast cancer drug succeeded in key study, but offers few details
The study is an important test of whether the drug, called Trodelvy, can live up to expectations set by Gilead's $21 billion deal to acquire it.
By Jacob Bell • March 7, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Roche, nearing major trial readouts, starts new Alzheimer's drug study
As Aduhelm sputters on the market, Roche aims to prove its experimental medicine can work better. A large, multi-year trial is part of that bet.
By Jonathan Gardner • March 3, 2022 -
Permission granted by Intellia Therapeutics
Intellia presses forward with new results for pioneering CRISPR drug
The findings build on early evidence that gene editing inside the body could safely and effectively treat disease, and suggest the effects of Intellia's medicine might last.
By Ben Fidler • Updated Feb. 28, 2022 -
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FDA rejects Reata drug for rare kidney disease
While expected, the decision raises questions about the treatment's prospects in other settings. Reata may have better luck with another drug it's submitting to the FDA for a movement disorder.
By Jonathan Gardner • Feb. 28, 2022 -
Permission granted by Datacubed Health
Sponsored by Datacubed HealthEngaging patients for the duration: 3 ways to improve retention in oncology studies
Tangible strategies to maximize the benefits and decrease the burdens of participants staying active and compliant in an oncology study.
Feb. 28, 2022 -
Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images
Moderna bets on booster demand, advancing new 'bivalent' COVID-19 shot
The biotech will start trials in the U.S. and U.K. of a vaccine that targets both the original coronavirus strain and the omicron variant.
By Jonathan Gardner • Feb. 24, 2022 -
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Allogene, slipping in 'off-the-shelf' CAR-T race, prepares for key trials
Allogene, once the clear leader in development of a more convenient option to personalized cancer cell therapies, now is competing with CRISPR Therapeutics and other fast-emerging rivals.
By Ben Fidler • Feb. 24, 2022 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Sanofi and GSK, after delays, to seek clearance for COVID-19 vaccine
The companies' vaccine provided strong protection against severe illness in a large clinical trial, a long awaited result that could position it as a booster for people who have received other shots.
By Jonathan Gardner , Ben Fidler • Feb. 23, 2022 -
Kodiak crashes on negative trial results for would-be Eylea competitor
Data from a Phase 3 trial showed Kodiak's experimental treatment didn't match up to Eylea in wet AMD, spurring questions from analysts about its potential.
By Kristin Jensen • Feb. 23, 2022 -
Ewa Krawczyk, National Cancer Institute
AstraZeneca, Daiichi press rivals with new results for breast cancer drug
Positive study results for the companies' drug Enhertu in patients whose only remaining option is chemo could open up a new treatment use, pressuring competitors Roche and SeaGen.
By Ben Fidler • Updated Feb. 23, 2022 -
Warren Little via Getty Images
Citing safety signal, GSK pauses some trials of new RSV vaccine
As RSV vaccine development heats up, the drugmaker said it will delay work on its shot for pregnant women, although separate studies in older adults remain on track.
By Jonathan Gardner • Feb. 18, 2022 -
Sage claims new data show depression drug works, but doubts remain
Study results indicate the company's fast-acting medicine may help patients already on existing drugs. But its limited effects may curb its potential, Wall Street analysts said.
By Ben Fidler • Feb. 16, 2022 -
Win McNamee via Getty Images
Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency
Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close.
By Jonathan Gardner • Updated Feb. 15, 2022 -
Amgen sees potential for KRAS drug in treating pancreatic cancer
Early study results suggest some efficacy for Amgen's KRAS-targeting drug in the tough-to-treat cancer type. The biotech plans to expand testing as a result.
By Ned Pagliarulo • Feb. 15, 2022 -
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EMA follows FDA in scrutinizing safety of certain immune drugs
The European regulator began a safety review of so-called Janus kinase inhibitors from Pfizer, AbbVie, Eli Lilly and Galapagos, citing worrisome data from a study of Pfizer's drug Xeljanz.
By Ned Pagliarulo • Feb. 14, 2022 -
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ProQR eye drug comes up short in key study, surprising company and investors
The biotech's treatment did not improve vision in the Phase 2/3 trial, a significant setback that sent shares down by 75%.
By Ned Pagliarulo • Feb. 11, 2022 -
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Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback
Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.
By Ned Pagliarulo • Feb. 10, 2022 -
Permission granted by Gilead Sciences
Pressure rises as Gilead awaits important study results for top cancer drug
Gilead expects data from a late-stage trial of Trodelvy, a medicine it acquired via its largest ever acquisition, next month. The results have come to be viewed as a key test of the company's ambitions in oncology.
By Jacob Bell • Updated Feb. 14, 2022
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