Clinical Trials: Page 32
-
Spencer Platt via Getty Images
EU regulator says member countries can use Pfizer's experimental COVID pill
The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.
By Ned Pagliarulo • Dec. 16, 2021 -
Permission granted by Biogen
Biogen reserves four years for trial meant to confirm its Alzheimer's drug works
In granting approval, the FDA gave Biogen roughly nine years to run and submit results from an additional study of Aduhelm. Now, the company says it will do so in about half the time.
By Jacob Bell • Dec. 16, 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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Sanofi, GSK say COVID vaccine works as booster, but delay key study results
The companies said their shot spurred increased immune responses in people who had received one of four widely used vaccines. But they still await long-anticipated data from a large Phase 3 study.
By Ben Fidler , Ned Pagliarulo • Dec. 15, 2021 -
Two cancer cell therapy studies succeeded. Why did a third fail?
Novartis' CAR-T drug Kymriah didn't appear better than standard of care in earlier lymphoma treatment. Its two similar rivals, Gilead's Yescarta and Bristol Myers' Breyanzi, did, raising questions about potential differences.
By Ned Pagliarulo • Dec. 14, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
In final analysis, Pfizer's COVID-19 pill remains highly effective
Full study results show Paxlovid cut the risk of COVID-19 hospitalization or death by about 90% among high-risk adults, matching the interim findings Pfizer disclosed last month.
By Ben Fidler • Dec. 14, 2021 -
ismagilov via Getty Images
Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug
Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.
By Jonathan Gardner • Dec. 14, 2021 -
Permission granted by The ALS Association
Deep Dive // ALS drug developmentOn the hunt for new ALS drugs, researchers see progress, and a long road ahead
The fatal nerve disease has few treatments. But despite continued setbacks, drug developers are hopeful that genetic technologies and a better understanding of biology will bring new options in the not-too-distant future
By Jacob Bell • Dec. 13, 2021 -
Courtesy of Gilead Sciences
CAR-T therapy trials show promise for earlier use in lymphoma
Study results presented at ASH suggest Gilead's Yescarta and Bristol Myers Squibb's Breyanzi could become replacements for stem cell transplants in treating the blood cancer.
By Ned Pagliarulo • Updated Dec. 13, 2021 -
Maddie Meyer via Getty Images
Moderna reveals first study results for seasonal flu vaccine
Data from a small Phase 1 trial showed the biotech's vaccine spurred immune responses to four common strains, although they didn't appear significantly greater than an already available shot from Sanofi.
By Ned Pagliarulo • Dec. 10, 2021 -
Permission granted by Roche
Latest Roche results show promise for new type of cancer immunotherapy
Updated Phase 2 data suggested an experimental drug targeting the protein TIGIT could bolster the benefit of Roche's Tecentriq in certain people with advanced lung cancer.
By Ben Fidler • Dec. 10, 2021 -
ismagilov via Getty Images
Fresh data show UniQure's hemophilia gene therapy appears to hold up
The amount of blood clotting protein found in patients who received the medicine was nearly the same at six months and 18 months post-treatment, according to results disclosed Thursday.
By Jacob Bell • Dec. 9, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Vaccine from Medicago, GSK protective against COVID-19 in large study
The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited.
By Jonathan Gardner • Dec. 7, 2021 -
Elizabeth Regan/BioPharma Dive
Acadia shares rise on study success for Rett syndrome drug
The biotech claims the results are enough to pursue an approval, but high rates of side effects and modest efficacy could raise questions about the treatment.
By Ned Pagliarulo • Dec. 7, 2021 -
Courtesy of Vertex Pharmaceuticals
Vertex, needing research spark, finds promising results in small study of kidney disease drug
The biotech, which has been stung by recent clinical setbacks, plans to soon advance the medicine into late-stage testing.
By Ned Pagliarulo • Dec. 1, 2021 -
cgtoolbox via Getty Images
With safety a concern, Merck, Gilead pause study of HIV drugs
Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.
By Jacob Bell • Nov. 24, 2021 -
A worrisome safety signal slows Merck's HIV ambitions
After a study raised safety concerns, Merck has paused development of one of its experimental drugs and will keep a close eye on another that's critical to its plans in HIV.
By Jacob Bell • Nov. 19, 2021 -
FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer
Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely.
By Ben Fidler , Ned Pagliarulo • Nov. 18, 2021 -
Permission granted by Cortexyme
Cortexyme plans path forward for Alzheimer's drug that failed study
Detailed trial results presented last week are "interesting," one Alzheimer's expert said, but there are still "many challenges and uncertainties" with Cortexyme's unorthodox approach to treating the disease.
By Ned Pagliarulo • Nov. 12, 2021 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Detailed Roche study results muddy another Alzheimer's hypothesis
Data presented at an Alzheimer's meeting raised more questions about the seeming benefit of Roche and AC Immune's drug semorinemab, which they claim is the first of its kind to slow deterioration of memory.
By Jonathan Gardner • Nov. 11, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
Mirati gives first look at KRAS drug combination in lung cancer
Study results for Mirati's drug combined with Keytruda have been much anticipated, as the San Diego biotech aims to challenge Amgen and its rival KRAS-blocking drug Lumakras.
By Ned Pagliarulo • Updated Nov. 8, 2021 -
Permission granted by Yourway
Sponsored by YourwayClinical trials face increasing challenges
The COVID-19 pandemic emerged at a time when the clinical trial landscape had reached a peak in complexity. Global trials are now commonplace as drug makers seek to establish efficacy in diverse populations.
By Hussein Pirbhai, Operations Director for UK and Europe, Yourway • Nov. 8, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158908/in/album-72157713108522106/.
Pfizer pill for COVID-19 shows dramatic benefit in major study finding
The drugmaker, which on Oct. 29 won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.
By Jonathan Gardner • Nov. 5, 2021 -
Permission granted by Cortexyme
Cortexyme drug fails in Alzheimer's trial, but company sees validation of unorthodox approach
Cortexyme shares lost more than three-fourths of their value after the the biotech's therapy, which is designed to work differently than drugs like Aduhelm, missed both primary goals in a late-stage study.
By Ned Pagliarulo • Oct. 26, 2021 -
Permission granted by Novartis
Novartis hits another setback in plan to repurpose rare disease drug in lung cancer
Canakinumab, which is approved as Ilaris, didn't slow progression or improve survival when used as a lung cancer treatment. Novartis still hopes it might work alongside surgery.
By Ned Pagliarulo • Updated Nov. 8, 2021 -
Permission granted by Biogen
Biogen's closely watched ALS drug comes up short in late-stage study
Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.
By Jacob Bell • Oct. 18, 2021
Previous
