Clinical Trials: Page 38
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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 -
Nastasic via Getty Images
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 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
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 -
Elizabeth Regan/BioPharma Dive
Icon to buy contract researcher PRA Health for $12B
The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.
By Kristin Jensen • Feb. 24, 2021 -
Jacob Bell/BioPharma Dive
FDA review supports safety, efficacy of J&J coronavirus vaccine
In their review, agency scientists provided new details on the shot's protection against severe COVID-19 and different virus variants as well as its potential to reduce transmission.
By Ned Pagliarulo , Jonathan Gardner • Updated Feb. 24, 2021 -
FDA lays out shortened path for testing vaccines against new coronavirus variants
Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.
By Ned Pagliarulo • Feb. 22, 2021 -
Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints
The companies think a new formulation will yield better results than their first attempt. But with several vaccines available, testing may be more challenging.
By Ben Fidler • Feb. 22, 2021 -
Shutterstock.com/Nikki Yoakum
Sponsored by Medidata, a Dassault Systèmes companyAccelerating virtual clinical trials
Leveraging the guidance and support of trial virtualization professionals with experience in key areas of a trial's lifecycle will undoubtedly impact overall success.
Feb. 22, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Why this week's FDA meeting on J&J's coronavirus vaccine will be important
The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.
By Ben Fidler , Ned Pagliarulo • Updated Feb. 23, 2021 -
Permission granted by Centessa Pharmaceuticals
10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model
The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.
By Ned Pagliarulo • Feb. 16, 2021 -
iStock.com/ljubaphoto
Sponsored by EthicaleReconciliation tool: A new software to facilitate Safety Data Reconciliation between clinical and safety databases
Simplify serious adverse events reconciliation operations with a customizable and GxP validated platform solution.
By Eleanor S. Segal, Luca Morbelli, Simone Suriano & Beat Widler • Feb. 16, 2021 -
Courtesy of AstraZeneca
AstraZeneca plans for adapting vaccine to coronavirus variants, but offers longer timeline than rivals
The drugmaker says between six to nine months are needed to ramp up production of an adapted shot. South Africa recently stopped using the vaccine due to its reduced potency against a common strain there.
By Jonathan Gardner • Feb. 11, 2021 -
Courtesy of Galapagos
Gilead, Galapagos halt development of experimental drug, denting research alliance
Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership.
By Kristin Jensen • Feb. 11, 2021 -
Permission granted by Roche
In surprise finding, Roche arthritis drug cuts risk of COVID-19 death in large UK study
U.K. researchers running the sprawling RECOVERY trial showed that adding Actemra to standard treatment can save lives, a powerfully positive result in a long-running debate about the drug's utility in COVID-19.
By Ben Fidler • Feb. 11, 2021
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