Clinical Trials: Page 48
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Courtesy of AstraZeneca
AstraZeneca, Oxford vaccine prevents COVID-19, though study results raise questions
Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19 — an encouraging finding. The lower dose tested, however, unexpectedly outperformed a higher dose.
By Ben Fidler • Updated Nov. 23, 2020 -
Permission granted by Gilead Sciences
WHO recommends against Gilead's Veklury, in break with US guidelines
The organization argues there's no evidence the antiviral saves lives or improves outcomes for COVID-19 patients, despite positive data on the latter point from a key U.S. study.
By Jonathan Gardner • Nov. 20, 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 -
UniQure's gene therapy for hemophilia B meets goal in key study
The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels.
By Ned Pagliarulo • Nov. 19, 2020 -
New AstraZeneca data offer latest hint coronavirus vaccines may protect elderly
Results published Thursday add to hopes the experimental shots now in testing won't only work for young, healthy people. More details are needed, though.
By Ben Fidler • Nov. 19, 2020 -
Permission granted by University of Maryland School of Medicine
New coronavirus vaccine data bolster Pfizer, BioNTech claims of strongly effective shot
Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just eight for those who were vaccinated.
By Ned Pagliarulo • Nov. 18, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Trial success for 2 coronavirus vaccines backs up early research bets
Positive data from Pfizer and Moderna offer the strongest validation yet of researchers' approach to coronavirus vaccines, but leave several questions still unanswered.
By Ned Pagliarulo , Ben Fidler • Nov. 17, 2020 -
Stem cell therapy for ALS fails a large clinical trial
The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.
By Jacob Bell • Nov. 17, 2020 -
Moderna says vaccine prevents COVID-19 in large study, adding to hopes for several protective shots
Multiple effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely.
By Ben Fidler • Nov. 16, 2020 -
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Sponsored by AltasciencesLigand binding program considerations – the value of preclinical to clinical bioanalytical expertise
Careful selection of a partner CRO can deliver advantages and accelerate your drug development program.
Nov. 16, 2020 -
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Sponsored by SAP5 reasons life sciences needs better clinical trial supply management
A new industry consortium is lining up stakeholders to work together to address long-standing pain points that disrupt clinical trials.
Nov. 16, 2020 -
AstraZeneca cancer drug found ineffective for COVID-19
The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19.
By Kristin Jensen • Nov. 12, 2020 -
Moderna close to having results from key coronavirus vaccine trial
The fast-accelerating spread of coronavirus in the U.S. has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results.
By Ned Pagliarulo • Nov. 12, 2020 -
Permission granted by BioNTech SE
Pfizer, BioNTech's strong results give lift to other coronavirus vaccines
The companies' early success helps validate an industry-wide bet to target the coronavirus' spike protein. But differences between each vaccine could still prove crucial.
By Jonathan Gardner • Nov. 11, 2020 -
Permission granted by BioNTech SE
Pfizer and BioNTech's coronavirus vaccine works. Here's what we still don't know.
An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details.
By Ned Pagliarulo , Ben Fidler • Nov. 10, 2020 -
Amgen's asthma drug delivers a needed win
A late-stage study found Amgen's tezepelumab benefited a variety of patients with severe asthma, results that one analyst called a "best-case outcome."
By Jacob Bell • Nov. 10, 2020 -
Coronavirus vaccine from Pfizer, BioNTech prevents COVID-19, early results show
An early look at Pfizer and BioNTech's large coronavirus vaccine study found the companies' experimental shot more than 90% effective, an encouraging result that bodes well for others in development.
By Jonathan Gardner • Updated Nov. 9, 2020 -
Permission granted by Novartis
Novartis rare disease drug, repurposed for COVID-19, fails in late-stage study
The Swiss drugmaker's COVID-19 research efforts now largely rest on the outcome of a recent alliance to develop oral medicines for the new coronavirus.
By Ben Fidler • Nov. 6, 2020 -
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Gene therapy for Duchenne muscular dystrophy: nearing final tests
Sarepta and Pfizer are advancing their experimental treatments into late-stage trials, while others are accelerating research in what's become one of gene therapy's most active fields.
By Ben Fidler • Nov. 5, 2020 -
Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma
Results the company will present at a medical meeting, while early, don't appear to meet the high bar set by rival CAR-T cell therapies from Bristol Myers Squibb and Johnson & Johnson.
By Ben Fidler • Nov. 4, 2020 -
Permission granted by Bristol-Myers Squibb
Bristol Myers bet pays off as psoriasis drug beats Amgen rival in study
While full data were not disclosed, the trial's outcome signals competition for Amgen's Otezla, which Celgene was forced to divest last year as a result of its acquisition by Bristol Myers.
By Ned Pagliarulo • Nov. 3, 2020 -
AstraZeneca partners with Fusion to test radiopharmaceuticals in cancer
While small in size, the collaboration gives AstraZeneca an entry point into radiopharmaceutical drug research, which was the focus of two Novartis buyouts in recent years.
By Ned Pagliarulo • Nov. 2, 2020 -
Courtesy of Regeneron Pharmaceuticals
Safety concerns lead Regeneron to halt testing of COVID-19 drug in some patients
A study monitoring board flagged a "potential safety signal" in some hospitalized COVID-19 patients who require breathing support, telling the biotech to modify its study protocol.
By Ben Fidler • Oct. 30, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Lilly antibody drug doesn't help hospitalized COVID-19 patients in NIH study
The results could raise doubts about the ability of synthetic antibody drugs to help patients already very sick with COVID-19.
By Ben Fidler • Updated Oct. 27, 2020 -
Digitalvision.com/The Good Brigade
Sponsored by Parexel InternationalIdentifying and recruiting patients into rare disease clinical trials: A multi-pronged and customized approach
Learn about strategies for identifying and recruiting rare disease patients.
By Sarah Glass, Ph.D., Shipra Patel, M.D., & Altair Silva, Parexel • Oct. 27, 2020 -
Retrieved from National Cancer Institute on September 27, 2019
Mirati cancer drug results spark hopes of outperforming Amgen's
The biotech's KRAS-blocking pill trails Amgen's sotorasib in development, but early data suggest it might match the bar set by Amgen.
By Jonathan Gardner • Oct. 26, 2020
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