Clinical Trials: Page 45
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
What to watch as the first late-stage coronavirus vaccine trials near potential readouts
Predictions of results by the end of October look ambitious, as the number of COVID-19 cases needed to generate definitive data could still take months.
By Jonathan Gardner • Updated Sept. 17, 2020 -
Vaccine makers, in bid for transparency, disclose detailed plans of coronavirus vaccine trials
Moderna was the first to share the so-called study protocol of its Phase 3 trial, spurring Pfizer and AstraZeneca to quickly do the same.
By Ned Pagliarulo • Updated Sept. 19, 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 -
Kendall Davis/BioPharma Dive
Arrowhead shares soar on liver disease data from four patients
Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.
By Jonathan Gardner • Sept. 16, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Lilly offers first evidence that its antibody drug may help treat COVID-19
The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear.
By Ben Fidler • Sept. 16, 2020 -
Permission granted by BioNTech SE
Pfizer says coronavirus vaccine study still on track for October readout
Unusually, the drugmaker also shared blinded safety results from its ongoing Phase 3 trial, showing participants' side effects were generally mild to moderate.
By Ned Pagliarulo • Sept. 15, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
Lilly says its arthritis drug helps speed COVID-19 recovery
The benefit of adding Lilly's Olumiant to Gilead's antiviral Veklury appeared modest, reducing time to recovery by one day in a study of hospitalized patients.
By Ned Pagliarulo • Sept. 14, 2020 -
AstraZeneca, Oxford vaccine study allowed to restart in UK
Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.
By Ben Fidler • Sept. 12, 2020 -
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 -
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
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