Clinical Trials: Page 55
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Courtesy of Novavax, Australian Broadcasting Corporation
Novavax buys more manufacturing capacity as first COVID-19 vaccine test begins
The Maryland biopharma has acquired a Czech vaccine developer for $167 million, gaining a facility in Europe that will boost its COVID-19 vaccine production capabilities.
By Kristin Jensen • May 28, 2020 -
Permission granted by Gilead Sciences
U.K. grants early access to Gilead's remdesivir for COVID-19 patients
Supplies of the antiviral drug are tight, however, with many of the doses donated by Gilead reserved for use in the U.S.
By Kristin Jensen • May 27, 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 -
Merck makes COVID-19 drug plans clear with flurry of deals
The drugmaker, which for months appeared to be watching the pandemic from the sidelines, will advance two coronavirus vaccine candidates, as well as an oral antiviral drug.
By Ned Pagliarulo , Ben Fidler • May 26, 2020 -
Permission granted by Gilead Sciences
New study details show remdesivir speeds COVID-19 recovery, but doesn't help sickest patients
Much anticipated results from an NIH-led trial of Gilead's antiviral drug were published Friday in the New England Journal of Medicine.
By Ned Pagliarulo • Updated May 25, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565892277/in/album-72157713108522106/.
Coronavirus study in China shows CanSino's vaccine spurs immune responses
But researchers, who conducted the trial in a locked-down Wuhan, aren't yet certain whether those responses will actually confer protection against coronavirus infection.
By Ned Pagliarulo • Updated May 22, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Intercept shares fall as FDA again delays closely watched NASH drug
The FDA has asked for more data on obeticholic acid, which could be the first-ever marketed medicine for non-alcoholic steatohepatitis. The latest delay means the drug likely won’t be approved by the agency's June 26 deadline.
By Jonathan Gardner • May 22, 2020 -
Courtesy of Galapagos
High expectations cast a shadow over Gilead and Galapagos' positive data
Filgotinib, a drug crucial to the companies' partnership, beat out placebo in a ulcerative colitis study. But lackluster results from a low dose could dim its competitive prospects.
By Jacob Bell • May 21, 2020 -
More questions than answers as Moderna's coronavirus vaccine speeds ahead
Preliminary results from a Phase 1 study were enough to add $5 billion to Moderna's market capitalization. But they don't answer key questions about the vaccine's safety and effectiveness.
By Jonathan Gardner • May 19, 2020 -
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Sponsored by PSI CROLeadership in crisis: How pharmaceutical industry leaders guide their teams while keeping clinical trials moving forward
Brenda Reese, head of North American business development for PSI CRO, discusses what's required of today's life sciences leaders.
May 19, 2020 -
Moderna delivers first human data for a coronavirus vaccine
The first volunteers who received low or medium doses of Moderna's vaccine produced what look to be meaningful immune responses, but it's unclear whether that will lead to disease prevention.
By Ben Fidler • May 18, 2020 -
Safety questions linger as Pfizer preps Duchenne gene therapy for final test
New data presented at the American Society of Gene & Cell Therapy's yearly meeting show promise, but also side effects that haven't been seen with a rival treatment from Sarepta.
By Ben Fidler • May 15, 2020 -
Alex Wong via Getty Images
Ousted BARDA director: Hydroxychloroquine push distracted government scientists
Safety concerns led to a clash over how widely to distribute the malaria pill for use against COVID-19, Rick Bright testified to Congress Thursday.
By Jonathan Gardner • May 14, 2020 -
Allogene gives first look at an 'off the shelf' cell therapy for lymphoma
Donor-derived cell therapy has been a goal for drugmakers since CAR-T arrived several years ago. New data from Allogene could offer "proof of concept."
By Ben Fidler • May 13, 2020 -
Roche unveils first data for new type of cancer immunotherapy
Study results for a new type of checkpoint inhibitor were mixed, offering signs of promise as well reasons for caution.
By Ned Pagliarulo • May 13, 2020 -
Alex Ritter, Jennifer Lippincott Schwartz and Gillian Griffiths, National Institutes of Health. (2015). "Killer T cells surround a cancer cell" [Image]. Retrieved from Flickr.
J&J myeloma data heat up cell therapy battle
Bristol Myers' regulatory stumble opens the door for other companies developing CAR-T therapies for multiple myeloma to catch up. ASCO data released Wednesday show J&J could be closing the gap.
By Jonathan Gardner • May 13, 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/.
Deep DiveA closer look at the race to develop antibody drugs for COVID-19
Eli Lilly, Regeneron and China's Junshi are now testing antibody drugs in clinical trials, while others are close behind. Here's why they will matter.
By Ben Fidler • May 12, 2020 -
Kendall Davis/BioPharma Dive
GenFit delivers latest NASH drug failure
The negative results for GenFit's elafibranor deal another another blow to the NASH field, which has seen only one drug make it through late-stage testing.
By Jacob Bell • May 11, 2020 -
MyoKardia pops as heart drug passes most important test
A late-stage study found patients with a condition similar to heart failure fared better when given MyoKardia's drug. The results sent company shares soaring.
By Jacob Bell • May 11, 2020 -
Moderna plans earlier start to late-stage test of coronavirus vaccine
A Phase 3 trial of Moderna's experimental vaccine could begin in early summer, several months sooner than what was already an ambitious target for starting this fall.
By Ned Pagliarulo • May 7, 2020 -
Novo's diabetes drug also appears to work in NASH
Results from a Phase 2 study showed three doses of Novo's semaglutide were better than placebo at resolving the liver disease without worsening fibrosis.
By Jacob Bell • May 6, 2020 -
Permission granted by BioNTech SE
Pfizer, BioNTech launch U.S. trial of coronavirus vaccine
Initial vaccine data are expected within weeks as biotech and pharma companies intensify their search for a way to prevent the spread of COVID-19.
By Jonathan Gardner • May 5, 2020 -
Akebia, chasing FibroGen, nears FDA review with new anemia pill data
The company is one of several aiming to upend the market for injectable anemia biologics, which generate billions of dollars in yearly sales.
By Ben Fidler • May 5, 2020 -
Courtesy of Centers for Disease Control and Prevention
Deep DiveA coronavirus vaccine may arrive next year. 'Herd immunity' will take longer.
Experimental vaccines for COVID-19 are moving at an unprecedented pace. But that could mean researchers won't definitively know whether they're safe and effective when they do arrive.
By Jonathan Gardner • May 4, 2020 -
Permission granted by Gilead Sciences
Gilead's remdesivir, shown to hasten COVID-19 recovery, cleared for emergency use by FDA
In a remarkably rapid turn, the FDA authorized the antiviral drug two days after positive results were announced from a closely watched government-run clinical trial.
By Ned Pagliarulo • Updated May 1, 2020 -
Agios drops as COVID-19 takes a toll on drug studies
The biotech listed nine studies in which it expects coronavirus-related effects on patient enrollment or data collection, including two late-stage trials of its closely watched drug mitapivat.
By Jacob Bell • May 1, 2020
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