Clinical Trials: Page 52
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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 -
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 -
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 -
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 -
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
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