Clinical Trials: Page 45
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Moderna secures almost $500M more as it starts first large-scale US study of coronavirus vaccine
Moderna went from designing a vaccine to a Phase 3 trial in historic time. Now the biotech will test whether its shot can truly help stop coronavirus' spread.
By Ben Fidler • July 27, 2020 -
iStock.com/Cecilie_Arcurs
Sponsored by YourwayFacilitating human clinical trials during and after COVID
Several centralized studies are being converted into decentralized/virtual studies to afford patients the ability to receive treatment at home.
July 27, 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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
On eve of first big coronavirus vaccine study, trial leaders brace for 'unprecedented' task
Researchers will need millions of volunteers to find the roughly 150,000 required for the five Phase 3 trials expected this year. Here's what lies ahead for them.
By Ben Fidler • July 24, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Early coronavirus vaccine data leave many questions, but some lessons, too
More is unknown than known about the four candidates for which early results have been disclosed. But the data provide a yardstick for assessing what comes next.
By Ned Pagliarulo • July 23, 2020 -
Brian Tucker/BioPharma Dive
Coronavirus vaccine developers make case to Congress they can win public's trust
While developing a safe and effective vaccine remains the chief challenge, lawmakers grilled pharma officials on how any successful shot would be fairly priced and distributed.
By Ben Fidler • July 21, 2020 -
Biogen to study use of key SMA drug after Novartis gene therapy
A planned trial is meant to test whether Spinraza can further help infants and young children who have already received Zolgensma, which, in theory, is meant to be curative if given very early on.
By Ned Pagliarulo • July 21, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
CanSino coronavirus vaccine clears mid-stage test, but data show its limits
More than half of participants in the Phase 2 study had pre-existing immunity to the cold virus CanSino uses for its shot, weakening the vaccine's effects.
By Ned Pagliarulo • July 20, 2020 -
Permission granted by University of Maryland School of Medicine
Pfizer and BioNTech coronavirus vaccine gets boost from German data
As the race to bring a vaccine to market accelerates, the companies unveiled new clinical results and a deal that promises the U.K. 30 million doses of a successful shot.
By Jonathan Gardner • July 20, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Oxford coronavirus vaccine spurs immune responses, appears safe on first look
The vaccine, from the University of Oxford and AstraZeneca, is backed with more funding from governments and non-profit groups than any other in development.
By Ben Fidler • July 20, 2020 -
New data from MeiraGTx help bolster J&J's gene therapy bet
The results are the first from a slate of gene therapies J&J licensed from Meira last year, a deal that remains the pharma's largest investment in the field.
By Ben Fidler • July 17, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
J&J, on the cusp of starting coronavirus vaccine trials, sets high bar for success
On a second quarter earnings call, J&J's top scientist said he expects the company's vaccine to significantly surpass the effectiveness standard set out by the FDA.
By Ned Pagliarulo • July 16, 2020 -
Researchers publish long-awaited study data on Moderna coronavirus vaccine
The results support the biotech's earlier claim of positive results, but don't show whether the vaccine protects against infection. Still, "we're so hungry for a vaccine we're trying to read the tea leaves," said vaccine expert Paul Offit.
By Ned Pagliarulo • Updated July 14, 2020 -
Preventive studies for Eisai, Biogen Alzheimer's drug could add years to amyloid debate
Two late-stage trials will assess the companies' experimental drug BAN2401 in people without Alzheimer's symptoms but with biological signs of the disease.
By Jonathan Gardner • July 14, 2020 -
Courtesy of Sanofi
Sanofi turns to MD Anderson to help fuel cancer drug push
The French pharma is counting on a five-year alliance with the cancer center to speed its early oncology research, a renewed focus under CEO Paul Hudson.
By Ned Pagliarulo • July 14, 2020 -
Spark, chasing BioMarin, plans 2021 start for key hemophilia gene therapy study
The Roche subsidiary said it will begin Phase 3 dosing its hemophilia A gene therapy next year, potentially putting it well behind a competing treatment from BioMarin.
By Jonathan Gardner • July 13, 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/.
India clears a psoriasis drug for COVID-19, and a tiny US biotech's shares soar
An emergency approval for Biocon's drug Alzumab in India could lead its U.S. partner, Equillium, to start broader trials in coronavirus disease.
By Ben Fidler • July 13, 2020 -
FDA documents reveal doubts about GSK blood cancer drug
Eye-related side effects could derail the leading drug that homes in on a new multiple myeloma target, just as rival therapies progress toward FDA review.
By Jonathan Gardner • July 10, 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/.
In the UK, a coronavirus study shows how to get fast, powerful data during a pandemic
RECOVERY, a large trial of COVID-19 treatments in the U.K., produced much of what the world knows about which medicines work and which do not.
By Ned Pagliarulo • July 10, 2020 -
ALS drug development
In the hunt for ALS treatments, researchers find promise in silencing genes
Two studies published in the New England Journal of Medicine, including one that tested a Biogen drug, provide some evidence that a decades-long effort to develop genetic medicines for ALS is starting to pay off.
By Jacob Bell • July 8, 2020 -
Courtesy of Novavax, Australian Broadcasting Corporation
Novavax gets $1.6B in US funding for coronavirus vaccine
The funding will secure 100 million doses of Novavax's experimental shot, which is set to begin late-stage testing this fall.
By Ned Pagliarulo • July 7, 2020 -
Courtesy of Regeneron Pharmaceuticals
Regeneron advances COVID-19 antibody cocktail into late-stage trials
The launch of a Phase 3 prevention study accelerates work on antibody-based drugs, which could offer strained healthcare systems a "bridge" to a vaccine.
By Jonathan Gardner • July 6, 2020 -
Permission granted by PRA Health Sciences
Sponsored by PRA Health SciencesCollaboration, not competition, will bring better pediatric medicines to market
Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.
July 6, 2020 -
Permission granted by BioNTech SE
Coronavirus vaccine from Pfizer, BioNTech shows early potential
Initial data from a small study of healthy volunteers show the companies' shot can elicit immune responses against the virus.
By Ned Pagliarulo • July 1, 2020 -
FDA insists it 'will not cut corners' in coronavirus vaccine approvals
New guidelines released by the agency detail what reviewers will require from drugmakers before approving or making available any coronavirus vaccine.
By Ned Pagliarulo • June 30, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Without data, Inovio says study shows positive results for coronavirus vaccine
The biotech is among the first few companies to disclose preliminary trial results for a coronavirus shot. But Inovio shared few details, making its announcement difficult to assess.
By Jonathan Gardner • June 30, 2020
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