Clinical Trials: Page 31
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ProQR eye drug comes up short in key study, surprising company and investors
The biotech's treatment did not improve vision in the Phase 2/3 trial, a significant setback that sent shares down by 75%.
By Ned Pagliarulo • Feb. 11, 2022 -
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Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback
Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.
By Ned Pagliarulo • Feb. 10, 2022 -
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 -
Permission granted by Gilead Sciences
Pressure rises as Gilead awaits important study results for top cancer drug
Gilead expects data from a late-stage trial of Trodelvy, a medicine it acquired via its largest ever acquisition, next month. The results have come to be viewed as a key test of the company's ambitions in oncology.
By Jacob Bell • Updated Feb. 14, 2022 -
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The pipeline of new antibiotics is drying up. A bill in Congress aims to change that.
Despite the growing threat of drug-resistant bacteria, few new antibiotics are reaching the market because of hurdles that biotech executives and experts say stand in the way.
By Jonathan Gardner • Feb. 1, 2022 -
Getty Images: Edited by BioPharma Dive
Madrigal adds to safety data for NASH drug
The biotech's drug is one of the few NASH treatments that has advanced to late-stage testing, as the disease has proven difficult for drugmakers to crack.
By Jacob Bell • Jan. 31, 2022 -
Courtesy of Regeneron Pharmaceuticals
Regeneron, Sanofi are latest to withdraw a cancer drug application
The partners pulled their request after disagreeing with the FDA on post-approval studies for their immunotherapy Libtayo in cervical cancer. Incyte made a similar decision earlier this week.
By Jonathan Gardner • Jan. 28, 2022 -
Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images
Moderna follows Pfizer in beginning trial of omicron vaccine
The study will test a version of the biotech's COVID-19 shot that's tailored to the infectious variant. New data, meanwhile, help affirm the benefit of a third dose of Moderna's current vaccine.
By Jonathan Gardner • Jan. 26, 2022 -
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Cortexyme to shift focus after FDA places hold on experimental Alzheimer's drug
While a recent trial of Cortexyme's drug had failed, the biotech was planning to move ahead with another study. Now the company is cutting costs and prioritizing an earlier-stage therapy.
By Ned Pagliarulo • Jan. 26, 2022 -
Jens Schlueter via Getty Images
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 -
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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