Clinical Trials: Page 51
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NIH starts broad set of studies testing blood thinners against COVID-19
The trials, which involve Bristol Myers and Pfizer's Eliquis as well as other anticoagulants, follow evidence of blood clotting in COVID-19 patients.
By Ben Fidler • Sept. 11, 2020 -
Sanofi's hemophilia drug comes into focus as delays hit a key competitor
With BioMarin's gene therapy sidelined, attention is turning to other drugs, including one Sanofi acquired when it paid $11.6 billion for Bioverativ.
By Jacob Bell • Sept. 10, 2020 -
Explore the Trendline➔
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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 -
Intra-Cellular roars back on success in bipolar depression
Widening the number of eligible patients could make Intra-Cellular's schizophrenia pill a blockbuster, analysts forecast.
By Jacob Bell • Sept. 9, 2020 -
Jacob Bell/BioPharma Dive
Merck takes aim at Pfizer with pneumonia vaccine data
Results from two Phase 3 studies put Merck in position to ask for FDA approval of its shot later this year. Pfizer may not be far behind with a rival product.
By Jonathan Gardner • Sept. 9, 2020 -
Studies of AstraZeneca coronavirus vaccine put on hold for safety review
A participant in a clinical trial of the experimental shot suffered an unexplained illness, triggering an investigation and a global pause in vaccinations.
By Ned Pagliarulo • Updated Sept. 9, 2020 -
Jacob Bell/BioPharma Dive
Merck details cough drug data, raising questions about its potential
Merck's drug could be the first-ever treatment for chronic cough, a condition that afflicts millions. But side effects and modest efficacy may limit its use.
By Jonathan Gardner • Sept. 8, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Researchers publish first data on coronavirus vaccine approved by Russia
While the shot appeared less potent than those being advanced by U.S. and U.K. companies, the Russian vaccine could be used broadly because it doesn't need to be kept frozen.
By Jonathan Gardner • Sept. 4, 2020 -
Akebia stumbles and clouds the prospects of anemia pills
The biotech's drug was found to be less safe than an injectable anemia medicine in a Phase 3 trial, dimming its potential approval chances.
By Ben Fidler • Sept. 3, 2020 -
Sanofi, GSK, racing to catch up, begin first human study of coronavirus vaccine
The two vaccine developers are betting their proven technology will lead to a more potent shot than others, making up for their slower pace of testing.
By Ben Fidler • Sept. 3, 2020 -
After a rare win, a biotech details long-awaited results for its ALS drug
Newly published data describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.
By Jacob Bell • Sept. 2, 2020 -
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 -
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
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