Clinical Trials: Page 50
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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 -
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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 -
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 -
Permission granted by Gilead Sciences
'We really did need a win.' Gilead drug no knockout in COVID-19, but results spur optimism
Doctors interviewed by BioPharma Dive said results from an important clinical trial of remdesivir were encouraging, even if its benefit seemed only modest.
By Ned Pagliarulo • April 30, 2020 -
AstraZeneca, racing past rivals, throws its weight behind Oxford's COVID-19 vaccine
The British drugmaker will take over development of an experimental vaccine that could produce its first clinical results next month.
By Ben Fidler • April 30, 2020 -
Iqvia cuts sales forecasts as coronavirus pandemic hits trial sites
The company, which helps biotech and pharma firms across the globe run clinical trials, said 80% of research sites are inaccessible due to travel restrictions enacted during the outbreak.
By Kristin Jensen • April 29, 2020 -
Permission granted by Gilead Sciences
Gilead drug for COVID-19 clears crucial clinical test
Data from an NIH-led study showed the antiviral therapy helped to speed recovery in patients hospitalized with coronavirus disease.
By Ned Pagliarulo • Updated April 29, 2020 -
Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women
A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. Whether it can truly help people, however, is not yet clear.
By Ben Fidler • April 28, 2020 -
Pfizer resumes trial recruitment suspended by coronavirus
After pausing enrollment into many studies in March, Pfizer is beginning to resume clinical activities at sites that are currently operational.
By Jonathan Gardner • April 28, 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/.
Repurposed arthritis drug disappoints in closely watched COVID-19 trial
A study of Regeneron and Sanofi's Kevzara will continue, but only for patients in the most critical condition after an early look suggested less-severe patients did worse than those taking placebo.
By Jonathan Gardner • April 27, 2020 -
Regeneron, Sanofi immunotherapy extends survival in previously untreated lung cancer
In a boost to the companies' come-from-behind immunotherapy bid, their drug Libtayo helped patients live longer than did chemotherapy. Improving on Keytruda, however, will be more challenging.
By Ned Pagliarulo • April 27, 2020 -
Axsome, beating the odds, finds success treating Alzheimer's agitation
The biotech's drug, which has shown promise in treating depression, pulled off an unusual feat in hitting the main goal of a late-stage Alzheimer's study.
By Jacob Bell • April 27, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Sanofi CEO cautions arthritis drug a 'long shot' in COVID-19, says study results 'imminent'
The drugmaker, along with partner Regeneron, is studying whether Kevzara can ease the severe respiratory symptoms experienced by some patients.
By Ned Pagliarulo • April 24, 2020 -
Another step for PARPs as AstraZeneca, Merck drug extends lives in prostate cancer
Lynparza is now the first PARP inhibitor to help prostate cancer patients live longer versus hormone therapy, giving it an edge over rival Rubraca.
By Ben Fidler • April 24, 2020 -
Permission granted by Gilead Sciences
Leaked data on Gilead's remdesivir suggest drug didn't help patients with COVID-19
Summary results from a study conducted in China were posted in error to the WHO's website Thursday, and painted a discouraging picture of the drug's effect on the disease.
By Ned Pagliarulo • Updated April 23, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Malaria drug's potential against coronavirus dims as data mounts
Hydroxychloroquine drew praise from President Donald Trump and TV doctors, but recent NIH guidelines and preliminary data build a case against its use.
By Jonathan Gardner • April 22, 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/.
Coronavirus vaccine from BioNTech, Pfizer set to enter testing in Germany
The study will test four versions of BioNTech's mRNA vaccine in 200 healthy volunteers, and is the first to be cleared to begin in Germany.
By Ned Pagliarulo • April 22, 2020 -
Alex Wong via Getty Images
BARDA director says he was ousted for 'clashes' with HHS over unproven therapies
In an extraordinary statement, Rick Bright said he was forced out as head of BARDA after disagreeing with department leadership on use of unproven malaria pills to treat COVID-19.
By Ned Pagliarulo • Updated April 22, 2020 -
Elizabeth Regan/BioPharma Dive
Trial data help small biotech ready its anti-itch drug for approval
Korsuva, a drug from Cara Therapeutics, has now succeeded in two Phase 3 trials in chronic kidney disease patients, setting the stage for potential approval filings in the U.S. and Europe.
By Jonathan Gardner • April 21, 2020 -
Positive data keep Bristol Myers and Exelixis in the kidney cancer race
A combination of Opdivo with Exelixis' Cabometyx, if cleared for use, would compete against an approved pairing of Merck's Keytruda and Pfizer's Inlyta.
By Jonathan Gardner • April 20, 2020
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