Clinical Trials: Page 39
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Courtesy of Eli Lilly
Lilly claims promising finding in failed study of COVID-19 drug
Baricitinib, an oral tablet already authorized to treat COVID-19, fell short of goal in a large Phase 3 study. But Lilly also reported treatment led to a substantial reduction in death.
By Ned Pagliarulo • April 8, 2021 -
New data push a biotech's muscle disease drug closer to a key test
An experimental medicine from Scholar Rock could complement a gene therapy from Novartis and other treatments for the disease, though its benefit needs to be proven in further study.
By Jacob Bell • April 6, 2021 -
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 Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Takeda, CSL to end alliance as plasma-based COVID-19 drug fails key test
An unusual partnership to develop a standardized plasma therapy for COVID-19 didn't succeed, but could be a model for collaborations should another public health crisis arise, the drugmakers said.
By Ben Fidler • April 5, 2021 -
Courtesy of BioNTech
Pfizer, BioNTech's vaccine protects 12- to 15-year-olds from COVID-19 in study
The positive finding should pave the way for broader use of the vaccine among adolescents, an important step for reaching herd immunity against the virus.
By Ben Fidler , Jonathan Gardner • March 31, 2021 -
A biotech shelves its Huntington's drugs after trial failures
Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.
By Jacob Bell • March 30, 2021 -
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Sponsored by Parexel BiotechHow RWE can help Biotechs optimize the value of their asset
No matter the exit strategy, the use of Real-World Evidence (RWE) can provide a framework for Biotech companies to develop insights needed for the various stakeholders.
March 29, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets late-stage win in test of new type of immunotherapy
When given together with Opdivo, Bristol Myers' new drug kept skin cancers from progressing, a rare clinical victory for a combination of immunotherapies that puts the pharma a step ahead of several rivals.
By Jonathan Gardner • March 25, 2021 -
Courtesy of AstraZeneca
AstraZeneca, under fire, tries to repair image with new vaccine data
Updated results show the vaccine is only slightly less effective than AstraZeneca originally reported. But an unusual break with a study committee may damage perception of the shot.
By Ben Fidler • Updated March 25, 2021 -
Regeneron joins Lilly in proving lower-dose antibody drugs can thwart COVID-19
The findings could help boost the supply and reach of Regeneron's COVID-19 antibody drug, which, despite limited use, is now backed by convincing data showing it can prevent hospitalization.
By Kristin Jensen • March 24, 2021 -
Roche stops giving Huntington's disease drug in closely watched study
A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals.
By Jonathan Gardner • March 23, 2021 -
FDA won't review Novo diabetes drug in latest case of regulatory pushback
Novo Nordisk said the FDA requested more data before starting review for a high dose of the Danish company's treatment semaglutide, extending a string of recent setbacks for drugmakers in the U.S.
By Ned Pagliarulo • March 23, 2021 -
AstraZeneca may have used 'outdated' data to describe vaccine's efficacy, NIH says
The British drugmaker said it will release updated data from the large U.S. trial within 48 hours, but the puzzling episode is another communication misstep for the company.
By Ned Pagliarulo • March 23, 2021 -
Permission granted by Roche
Roche immunotherapy notches a win in early lung cancer, pressuring Merck
New results could make Tecentriq the first immunotherapy available in the post-surgery setting, adding pressure on Merck & Co.'s Keytruda to succeed as well.
By Jonathan Gardner • March 22, 2021 -
Shutterstock.com/Stokkete
Sponsored by PSI CROTechnological adoption and human connection. Finding the balance in clinical trials
While technology can push trials ahead, in-person interactions and site relationships are, and always will be, the key to success in delivering patient-centric trials on time.
March 22, 2021 -
Shutterstock.com/Sergey Kolesnikov
Sponsored by Medidata, a Dassault Systèmes companyAdopting RBQM to ensure trial oversight in COVID and beyond
Now more than ever, a firm grasp of RBQM is needed for the success of all clinical trials.
March 22, 2021 -
Yujin Kim/BioPharma Dive
With new results, Sarepta's 2nd gene therapy holds steady
Stung by a clinical trial miss in Duchenne muscular dystrophy, the biotech now has promising, if early, data to back a gene therapy for a different rare neuromuscular disease.
By Jonathan Gardner • March 19, 2021 -
A first-of-its-kind mRNA drug falls short in cystic fibrosis
A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines.
By Ben Fidler • March 18, 2021 -
Kendall Davis/BioPharma Dive
Gilead, still aiming at NASH, broadens an alliance with Novo
With positive safety data in hand, the partners will advance work pairing the diabetes medicine Ozempic with two experimental treatments to see if they can reverse the liver disease, which has proven a tough target for drugmakers.
By Jonathan Gardner • March 18, 2021 -
Courtesy of Eli Lilly
Lilly lays out 2-year plan to gain approval for Alzheimer's drug
Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.
By Jonathan Gardner • March 15, 2021 -
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Sponsored by Koneksa HealthThe Apple Watch in clinical trials: Current uses and future possibilities
Why the Apple Watch will likely be one of the top choices for use by sponsors, CROs and clinical trial teams wishing to use wearables in their trials.
March 15, 2021 -
Detailed Lilly data give mixed picture of Alzheimer's drug's benefit
Highly anticipated results from a Phase 2 study of donanemab showed treatment slowed disease progression on one measure, but mixed data on other scales could temper optimism in its potential.
By Jonathan Gardner • March 13, 2021 -
Courtesy of Eli Lilly
Lilly builds case for COVID-19 drug cocktail with new data
A low-dose combination of Lilly antibodies for COVID-19 reduced deaths and hospitalizations in a Phase 3 trial, a finding that could boost its use.
By Kristin Jensen • March 10, 2021 -
Permission granted by Novartis
Novartis bid to bring rare disease drug to lung cancer hits a roadblock
Promising signs from a cardiovascular trial had led the Swiss firm to test canakinumab, a drug for rare immune diseases, in lung cancer. But the first test of that theory has failed.
By Jonathan Gardner • March 9, 2021 -
Jacob Bell/BioPharma Dive
Merck gives an early peek at COVID-19 drug results
Initial results from a mid-stage study indicate the antiviral drug, molnupiravir, is safe. But whether it's hitting the study's main goal remains unclear.
By Jacob Bell • March 8, 2021 -
Courtesy of AstraZeneca
Crucial data on AstraZeneca's vaccine are coming. Here's what we may learn.
Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion.
By Ben Fidler • March 8, 2021
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