Clinical Trials: Page 36
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BioMarin plans return to FDA with updated data on hemophilia gene therapy
Two-year results from a Phase 3 study of Roctavian show treatment prevented bleeding, potentially giving BioMarin the data it needs to resubmit an application for approval.
By Ned Pagliarulo • Updated Jan. 10, 2022 -
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Sponsored by FedExLeveraging print and digital communications for patient-centric clinical trials
The demand for communicating and reaching trial participants where they live in the most convenient and effective fashion is growing daily and having a dynamic print solution can help make that happen.
Jan. 10, 2022 -
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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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Avrobio stops work on rare disease gene therapy after unexpected study results
The biotech's gene therapy was one of the furthest along in testing for Fabry, a rare inherited disease that's become a target for drug developers.
By Ned Pagliarulo • Jan. 4, 2022 -
Kendall Davis/BioPharma Dive
Deep Dive10 clinical trials to watch in the first half of 2022
Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around.
By Ben Fidler • Updated Jan. 6, 2022 -
Allakos shares plunge as company's top drug falls short in studies
The drug's effect in tissue did not appear to translate to a benefit in reducing symptoms, surprising executives at the biotech as well as its investors.
By Kristin Jensen • Dec. 22, 2021 -
Permission granted by Gilead Sciences
Gilead, following Merck, hits its own safety setback in HIV
The FDA has halted all clinical trials testing the injectable form of Gilead's lenacapavir, for fear that incompatibility between the drug and the vials it's held in could cause contamination.
By Jacob Bell • Dec. 22, 2021 -
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Duchenne patient dies in Pfizer gene therapy study
The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants.
By Jonathan Gardner • Dec. 21, 2021 -
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Sponsored by FedEx OfficeSupporting multi-audience communication in all stages of drug development
Biopharmaceutical companies have ongoing and extensive needs for print and digital communications throughout the drug development life cycle that can benefit from a single-source vendor.
Dec. 20, 2021 -
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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 -
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 -
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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 -
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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 -
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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 -
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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
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