Clinical Trials: Page 34
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Adagio plans comeback for COVID drug, but is it too late?
The biotech said it will ask the FDA for approval of its antibody treatment after positive results from two trials. But relatively few participants were exposed to omicron, potentially raising questions about its utility.
By Jonathan Gardner • March 30, 2022 -
Roche's top immunotherapy prospect fails study in tough-to-treat lung cancer
A drug regimen including Roche's closely watched tiragolumab didn't outperform standard treatment in its first large trial, a setback for therapies aimed at a protein called TIGIT.
By Ben Fidler • March 30, 2022 -
Explore the Trendline➔
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TrendlineNeuroscience 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 -
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Pfizer inflammatory disease drug hits goal in second study
The drugmaker said etrasimod, an experimental medicine acquired via its Arena buyout, improved remission rates in the second of two studies meant to support its approval in ulcerative colitis.
By Ned Pagliarulo • March 29, 2022 -
Sarah Silbiger via Getty Images
Deep Dive // ALS drug developmentHow a long shot ALS drug came before the FDA
A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision.
By Jacob Bell • March 28, 2022 -
Permission granted by Biogen
Biogen shelves ALS drug after early-stage trial failure
The study setback raises questions over how well a type of genetic medicine can work in adults with central nervous system disorders like ALS.
By Jonathan Gardner • March 28, 2022 -
Permission granted by Mateusz Bartkowiak (QIAGEN)
Sponsored by QIAGENHow to accelerate reliable and novel answers with expert-curated biomedical and clinical data
Accelerate your path to novel, reliable answers with expert-curated biomedical and clinical data.
March 28, 2022 -
Sarah Silbiger via Getty Images
FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny
The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.
By Jonathan Gardner • March 25, 2022 -
Spencer Platt via Getty Images
Pfizer claims study success for drug key to Arena buyout
Etrasimod, the basis of the $7 billion acquisition and a potential rival to Bristol Myers Squibb's Zeposia, has cleared the first of two trials in ulcerative colitis.
By Kristin Jensen • March 23, 2022 -
Sergio Flores via Getty Images
Moderna, with new data, to seek clearance for COVID-19 vaccine in young children
Study results showed two shots of Moderna's vaccine led to similar immune responses as has been observed in young adults, although protection versus omicron was modest.
By Ben Fidler • March 23, 2022 -
Elizabeth Regan/BioPharma Dive
Argenx boosted by positive trial results for new shot
An easier-to-take version of Vyvgart could help Argenx expand the drug's use in autoimmune disease, potentially adding to the biotech's appeal as an acquisition target.
By Jonathan Gardner • March 22, 2022 -
Vertex plans path to FDA for top drug prospect
After observing promising results in a small study, Vertex is moving ahead with a pivotal trial for a kidney disease drug that's become a key part of the company's efforts to grow beyond cystic fibrosis.
By Ned Pagliarulo • Updated March 22, 2022 -
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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 -
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
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