Clinical Trials: Page 33
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Permission granted by Advarra
Sponsored by AdvarraWhy prescreening is the missing piece in a successful participant pipeline
Too often, optimized prescreening is overlooked in favor of the status quo. Here's why that's a mistake—and why prescreening is the great missed opportunity for modern-day trial enrollment.
Oct. 18, 2021 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
CRISPR touts new results as fresh questions surround 'off-the-shelf' CAR-T
The biotech's lymphoma treatment initially seems as potent as earlier cell therapies, but its effects waned, adding to doubts about off-the-shelf CAR-T.
By Jonathan Gardner • Updated Oct. 13, 2021 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Courtesy of Sarepta
Sarepta outlines final push for Duchenne gene therapy
The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call.
By Ben Fidler • Oct. 11, 2021 -
Permission granted by Clinical Ink
Sponsored by Clinical InkeCOA clinical trials: A simple, cost-effective approach to study build
This new data capture model gives clinical trial sponsors control over study build.
Oct. 11, 2021 -
Permission granted by Relay Therapeutics
Relay’s targeted cancer drug could be safer than its competitors. Is it more effective?
Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too.
By Ned Pagliarulo • Oct. 8, 2021 -
Sarah Silbiger via Getty Images
Allogene cell therapy trials halted by FDA after unexpected safety finding
Researchers found evidence of a "chromosomal abnormality" in one patient treated with Allogene's CAR-T cell therapy, spurring the clinical hold and an investigation.
By Ben Fidler • Updated Oct. 8, 2021 -
Takeda halts studies of touted sleep disorder drug over safety concern
The drugmaker suspended dosing in two mid-stage studies of its experimental narcolepsy treatment after a "safety signal" emerged.
By Ned Pagliarulo • Oct. 6, 2021 -
Chip Somodevilla via Getty Images
Collins to step down as NIH head in transition for research agency
After 12 years in the top job, the veteran director says a new scientist should assume leadership of the world's largest biomedical research institution.
By Jonathan Gardner • Oct. 5, 2021 -
Mario Tama via Getty Images
J&J heats up RSV race with new vaccine data
The company's candidate is one of two to enter late-stage testing for a respiratory virus that causes hundreds of thousands of hospitalizations a year.
By Jonathan Gardner • Oct. 4, 2021 -
Courtesy of Sarepta
Sarepta embarks on late-stage clinical trial of Duchenne gene therapy
Initiation of the Phase 3 trial is an important milestone for the biotech after earlier setbacks, as well as for patients with the inherited muscle disease.
By Shoshana Dubnow • Oct. 4, 2021 -
Courtesy of Merck & Co.
Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug
The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible" following results so striking that testing was stopped early.
By Ben Fidler • Oct. 1, 2021 -
Permission granted by Editas Medicine
After long wait, Editas reveals first data for CRISPR gene editing treatment
Early study results offer some hopeful signs but were difficult to interpret. Shares in the biotech slid by nearly 20% in response on Wednesday.
By Ned Pagliarulo • Sept. 29, 2021 -
Courtesy of Sanofi Pasteur
Sanofi claims positive early data for mRNA COVID shot, but pivots to flu instead
With Pfizer's and Moderna's vaccines broadly used, Sanofi says it will focus on its protein-based coronavirus candidate. The French pharma sees more promise for its mRNA work in influenza.
By Jonathan Gardner • Sept. 28, 2021 -
Erik S. Lesser via Getty Images
As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial
Phase 3 results showed Merck's drug improved overall survival versus placebo, which should lessen pressure for a market withdrawal in the indication.
By Jonathan Gardner • Sept. 27, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial
Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.
By Jonathan Gardner • Sept. 22, 2021 -
Antonio Masiello via Getty Images
Pfizer says coronavirus vaccine is safe and spurs immune response in children
The results position Pfizer and BioNTech to seek clearance in children as young as 5 years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.
By Jonathan Gardner • Sept. 20, 2021 -
ESMO21: Mirati sets new KRAS bar, AstraZeneca's breast cancer data and Keytruda challengers line up
Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.
By Ned Pagliarulo • Updated Sept. 21, 2021 -
Permission granted by Biogen
Biogen says experimental pain drug helps neuropathy patients in mid-stage trial
With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug.
By Jonathan Gardner • Sept. 17, 2021 -
Amgen to advance KRAS drug combination after improved results in colon cancer
Combining Amen's Lumakras with its drug Vectibix appeared to work better in treating colorectal cancer than Lumakras alone, spurring the biotech to unveil plans for a new Phase 3 trial.
By Ned Pagliarulo • Sept. 16, 2021 -
Permission granted by University of Maryland School of Medicine
New data from Israel, Pfizer show potent effect from third coronavirus shot
The much-anticipated data arrive ahead of an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.
By Jonathan Gardner • Sept. 15, 2021 -
Courtesy of Apellis Pharmaceuticals
Apellis eye drug succeeds in one key study, but falls short in its twin
Highly anticipated study results showed divergent outcomes for the biotech's therapy in treating a form of vision loss known as geographic atrophy. Even so, Apellis plans to soon ask for FDA approval.
By Ned Pagliarulo • Updated Sept. 10, 2021 -
Courtesy of Sanofi
Sanofi drug for rare skin disease, acquired in buyout, fails in late-stage trial
The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.
By Jonathan Gardner • Sept. 9, 2021 -
Autism drug fails in late-stage trials, Servier says
The French drugmaker and its biotech partner Neurochlore agreed to end two Phase 3 studies early after finding no signs that treatment was effective.
By Kristin Jensen • Sept. 8, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Pfizer, Merck launch large new trials of oral COVID-19 drugs
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.
By Kristin Jensen • Sept. 1, 2021 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Hint of benefit in Alzheimer's drug study fuel stock surge for Swiss biotech
A once-failed drug being developed by AC Immune and Roche appeared to slow cognitive decline in a small trial. But other study goals were missed, muddying the seemingly positive result.
By Ned Pagliarulo • Aug. 31, 2021
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