Clinical Trials: Page 44
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NIH panel says data doesn't support plasma use for COVID-19
The expert advisers' determination appears to conflict with a decision by the FDA last week to clear the blood-derived treatment for emergency use.
By Ned Pagliarulo • Sept. 2, 2020 -
Permission granted by University of Maryland School of Medicine
Healthcare workers likely to be first in line for coronavirus vaccination
Initial vaccine supplies will be limited. Advisory groups, most recently the National Academies, are developing plans for who should get access first.
By Jonathan Gardner • Sept. 1, 2020 -
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 -
Courtesy of Sanofi
Sanofi ends research of arthritis drug as coronavirus treatment
Kevzara failed to shorten hospital stays among patients severely sick with COVID-19, study results showed, further dimming hopes that drugs similar to it could help combat the disease.
By Jonathan Gardner • Sept. 1, 2020 -
AstraZeneca, vowing it won't cut corners, begins large US study of coronavirus vaccine
Amid reports the U.S. might fast-track AstraZeneca and the University of Oxford's experimental shot, the company pledged to "follow the science."
By Ben Fidler • Sept. 1, 2020 -
With latest data, a gene therapy for a deadly brain disease inches closer to market
The results keep Bluebird Bio on track to seek approval of the experimental treatment, known as eli-cel, in Europe later this year and in the U.S. in 2021.
By Jacob Bell • Aug. 29, 2020 -
New data from J&J, Arrowhead mark latest step in RNAi's hepatitis B race
The Arrowhead drug, which J&J licensed in 2018, is one of four rival programs in clinical testing aiming for a 'functional cure' for chronic infections.
By Ben Fidler • Aug. 28, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
CanSino said to seek early authorization of coronavirus vaccine
The reported talks between CanSino and several countries highlight the urgency with which governments are operating to secure supply of experimental coronavirus vaccines.
By Jonathan Gardner • Aug. 28, 2020 -
Moderna says its coronavirus vaccine sparks immune response in older people
An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.
By Jonathan Gardner • Aug. 26, 2020 -
Freenome raises $270M to run pivotal trial of colorectal cancer blood test
The 14,000-person study could set the company up to compete with Exact Sciences and Guardant Health for the colorectal cancer screening market.
By Nick Paul Taylor • Aug. 26, 2020 -
New data lead Ovid, Takeda to push seizure drug into final testing
The partner companies found that, when tested in two types of rare epilepsy, their drug seems to perform better in one. But they see a path forward in both.
By Jacob Bell • Aug. 25, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
AstraZeneca's coronavirus antibody drug cocktail begins human tests as rivals slip
The British pharma has started a Phase 1 trial amidst reports that competing programs from Regeneron and Eli Lilly haven't met their projected timelines.
By Ben Fidler • Aug. 25, 2020 -
Permission granted by BioNTech SE
Coronavirus vaccine Pfizer, BioNTech chose for late-stage testing appears safer than first
Preliminary data showed the pair's second experimental shot caused less fever, without compromising potency, when compared to an earlier version.
By Jonathan Gardner • Updated Aug. 21, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Russia, with scant study data, approves coronavirus vaccine
The shot, developed by the state-backed Gamaleya Research Institute, hasn't yet been tested in the large, placebo-controlled tests scientists emphasize are needed to prove a vaccine is protective.
By Ned Pagliarulo • Updated Aug. 11, 2020 -
Seres finds the microbiome data it's been waiting for
The biotech's value more than quadrupled after reporting pivotal data that, according to executives, "substantially exceeded" what's needed for approval.
By Jacob Bell • Aug. 10, 2020 -
Courtesy of Novavax, Australian Broadcasting Corporation
With first results, Novavax takes step forward in coronavirus vaccine race
Early-stage results appear to show that Novavax's shot passed its first meaningful test, helping the Maryland biotech keep pace with larger competitors.
By Ben Fidler • Aug. 4, 2020 -
Novartis says CAR-T cancer therapy works in second lymphoma type
Early results from a trial testing Kymriah in follicular lymphoma were reportedly positive, supporting the pharma's plans to ask for another approval.
By Ned Pagliarulo • Aug. 4, 2020 -
Shutterstock.com/Flamingo Images
Sponsored by WCGCOVID-19 changed everything: Now contracts and budgets need to catch up
As the pandemic continues, we see teams will be recalibrating everything, especially study budgets.
Aug. 4, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Big pharma alliance recruits first patients for unusual COVID-19 study
The trial is testing whether drugs from Amgen, Takeda and AbbVie can combat the life-threatening immune overreaction some COVID-19 patients experience.
By Jacob Bell • Aug. 3, 2020 -
Courtesy of Eli Lilly
Lilly to test COVID-19 antibody drug in unorthodox nursing home study
Seeking fast answers in a pandemic, Lilly will use mobile RVs to set up infusion clinics at assisted living facilities, which have become COVID-19 hot spots.
By Ben Fidler • Aug. 3, 2020 -
Merck nears clinical tests for coronavirus vaccine candidates
Two candidates recently acquired in deals with IAVI and Themis have shown promise in preclinical studies, Merck executives said, and Phase 1 trials will begin later this year.
By Ned Pagliarulo • July 31, 2020 -
US promises $2.1B to Sanofi, GSK in latest coronavirus vaccine deal
The contract is the largest yet from the Trump administration's Operation Warp Speed, although Sanofi and GSK have yet to begin clinical testing of their shot.
By Ned Pagliarulo • July 31, 2020 -
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/.
AstraZeneca signals it won't wait for US data to seek clearance of coronavirus vaccine
The British drugmaker indicated on a conference call that data from trials already underway in the U.K., Brazil and South Africa will be sufficient to ask regulators to approve the vaccine.
By Jonathan Gardner • July 30, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
J&J, beginning first human trial, aims for a 1-shot coronavirus vaccine
Preclinical data published Thursday suggest one dose of J&J's vaccine could protect against coronavirus disease, but that goal has proved difficult for drugmakers so far.
By Ben Fidler • July 30, 2020 -
A Roche arthritis drug fails in COVID-19, casting doubt on a strained hypothesis
Negative results for Actemra follow setbacks for Kevzara, which works similarly, and further weaken the case that the drugs could help treat severe COVID-19.
By Ben Fidler • July 29, 2020 -
Permission granted by University of Maryland School of Medicine
BioNTech, Pfizer pick a surprise coronavirus vaccine, follow Moderna into late-stage test
After testing four variations of their vaccine, the companies chose a different version for Phase 3 than the one previously thought to be most advanced.
By Ben Fidler • Updated July 28, 2020
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