Clinical Trials: Page 35
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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 -
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TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
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 -
Spencer Platt via Getty Images
Pfizer drug bests Sanofi, Regeneron's Dupixent in head-to-head study
Abrocitinib, a JAK inhibitor Pfizer's developing, outperformed Dupixent in treating moderate or severe eczema. Hanging over the study's success, however, is an ongoing review by the FDA of the drug's class.
By Ned Pagliarulo • Aug. 30, 2021 -
Christopher Furlong via Getty Images
AstraZeneca reports study success for rare disease drug acquired in Alexion deal
With positive results from a Phase 3 trial in hand, the British pharma intends to soon seek regulatory approval for the Wilson disease treatment.
By Kristin Jensen • Aug. 26, 2021 -
Mario Tama via Getty Images
With new results, J&J's $1B gamble on a targeted inflammation drug faces long odds
Theravance, which agreed to co-develop a next-generation JAK inhibitor with J&J three years ago, said the experimental drug failed a mid-stage study in ulcerative colitis, leaving its future in doubt.
By Jonathan Gardner • Aug. 24, 2021 -
Alexion discontinues ALS drug trial due to 'lack of efficacy'
The decision, which follows the recommendation of a data monitoring committee, is yet another setback in the search for more treatments for the neurological disease.
By Shoshana Dubnow • Aug. 23, 2021 -
Shutterstock.com
Sponsored by PSI CROA pandemic lesson for every CRO: Empower infrastructure to handle crises
Here are some ways CROs can prepare for the worst and keep their trials moving smoothly.
Aug. 23, 2021 -
Courtesy of Eli Lilly
Lilly's new eczema drug scores in late-stage studies
Positive results help validate the $1 billion acquisition that gave Lilly access to lebrikizumab. Even so, the company could face tough competition from Regeneron and Sanofi's Dupixent.
By Jacob Bell , Ben Fidler • Aug. 16, 2021 -
Roche sets bar in early lymphoma treatment with Polivy study results
Positive data for the Swiss pharma's antibody-based drug could be a benchmark for CAR-T therapies, which other developers aim to move into early lymphoma treatment, too.
By Jonathan Gardner • Aug. 9, 2021 -
Regeneron drug extends survival in lung cancer trial, lifting company's hopes in field
The biotech also reported second quarter earnings on Thursday that widely surpassed Wall Street expectations.
By Jonathan Gardner • Aug. 5, 2021
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