Clinical Trials: Page 45
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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 -
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 -
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AstraZeneca may have used 'outdated' data to describe vaccine's efficacy, NIH says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 -
Permission granted by Clinical Ink
Sponsored by Clinical InkWhat's new in ePRO, the customer service behind it, and how you can benefit
A single deployment now allows users to input ePRO on their device of choice, wherever they may be.
March 8, 2021 -
Courtesy of Eli Lilly
Lilly says diabetes shot outperformed rival Novo drug in study
The results are a boost for Lilly's drug, tirzepatide, which is being prepared for regulatory submissions later this year. But long-term heart data won't be available for some time.
By Jonathan Gardner • March 4, 2021 -
Galapagos reports long-awaited safety data for inflammation drug
The data show similar declines in sperm counts among patients on the Belgian biotech's drug, filgotinib, or a placebo. But it's unclear whether that finding will appease the FDA, which surprisingly rejected filgotinib last year.
By Jacob Bell • March 4, 2021 -
Courtesy of Eli Lilly
Lilly drug regrows hair in autoimmune disease study, but safety questions linger
The results could help baricitinib become the first treatment for alopecia areata, a leading cause of hair loss. Safety concerns have diminished the drug's prospects in arthritis, however.
By Ben Fidler • March 3, 2021 -
A closely watched schizophrenia drug fails key test
Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.
By Jacob Bell • March 2, 2021 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
A play-by-play of the FDA meeting on J&J's vaccine
FDA advisers expressed growing comfort with the authorization process, offering unanimous support for J&J's shot. But the meeting also gave a window into debates likely to play out in the coming weeks and months.
By Ben Fidler , Ned Pagliarulo , Jonathan Gardner • Updated March 1, 2021 -
Moderna, Pfizer ready multi-pronged plans for coronavirus variants
Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.
By Jonathan Gardner , Ben Fidler • Updated Feb. 25, 2021
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