Clinical Trials: Page 33
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With new trial, Pfizer and BioNTech will test whether an omicron vaccine is needed
The trial, which will enroll nearly 1,500 people, could help determine whether a variant-specific shot is more effective than an additional booster of Pfizer's original vaccine.
By Ben Fidler • Jan. 25, 2022 -
Elizabeth Regan/BioPharma Dive
Sierra Oncology records success in late-stage study of bone cancer drug
The biotech said it plans to soon submit the drug, which it acquired for cheap from Gilead three years ago, to the Food and Drug Administration for approval.
By Jacob Bell • Jan. 25, 2022 -
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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 -
Roche sees cause for optimism with failed Huntington's disease drug. Others aren't so sure.
After halting a Phase 3 trial of the drug last year, Roche went digging for more data. What it found led to plans for another trial, but the pharma's hypothesis may rest on shaky ground.
By Ned Pagliarulo , Jacob Bell • Jan. 21, 2022 -
Alnylam, awaiting key study data, builds case for its next rare disease drug
New results show the effects of its next drug for transthyretin amyloidosis appear to hold up for a year and a half. But it's unclear whether treatment will help those with heart problems, a much larger market opportunity.
By Ben Fidler • Jan. 21, 2022 -
EQRx builds case for cancer drug it hopes can disrupt market
Study results show EQRx's drug, which it means to position as a lower-cost alternative to widely used cancer immunotherapies, extended the lives of lung cancer patients. But it's unclear whether that will be enough to sway the FDA.
By Kristin Jensen • Jan. 19, 2022 -
Roche revives a closely watched Huntington's disease drug
Ten months after Roche stopped giving the drug to patients in a Phase 3 trial, the pharma is planning a new study on the belief the medicine may help younger adult patients with less advanced disease.
By Jonathan Gardner , Ben Fidler • Jan. 18, 2022 -
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Sponsored by FedExLeveraging print communications in support of clinical trial diversity
Ensuring clinical studies reflect the real-world patient populations as much as possible in terms of ethnicity, race, sex and age
Jan. 18, 2022 -
Permission granted by Biogen
Medicare proposes to limit coverage of Biogen Alzheimer's drug
The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.
By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022 -
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Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials
A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.
By Ben Fidler • Jan. 10, 2022 -
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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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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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