Clinical Trials: Page 37
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
GSK, Vir build case for COVID-19 antibody drug with new study data
Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19.
By Ned Pagliarulo • June 21, 2021 -
Kendall Davis/BioPharma Dive
Deep Dive8 key clinical trials to watch for the rest of 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19 and gene-targeted cancer therapy.
By Ben Fidler • June 21, 2021 -
Explore the Trendline➔
Getty Images
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 -
Permission granted by PRA Health Sciences
Sponsored by PRA Health SciencesMaking progress towards equity and diversity in rare diseases
Understanding the nuances of the rare disease space is critical to increasing diversity and equity for underserved and underrepresented minorities.
June 21, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
US to invest $3B in research quest for COVID-19 pill
Compared to vaccines, development of antiviral drugs for the coronavirus has progressed more slowly, although data are expected soon from Merck, Pfizer and Atea.
By Ned Pagliarulo • June 18, 2021 -
Trial failure dashes Biogen hopes for next Alzheimer's drug
Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research.
By Jonathan Gardner • June 17, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Regeneron antibody cuts risk of COVID-19 death in UK study
The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.
By Kristin Jensen • June 16, 2021 -
Biogen gene therapy deal has yet to bear fruit
Another gene therapy from Nightstar Therapeutics, which Biogen bought for $800 million in 2019, has failed in a key clinical study.
By Jacob Bell • June 15, 2021 -
Sage antidepressant succeeds in key study, but data raise questions
Zuranolone, a drug that's crucial for Sage's future and the focus of a multi-billion dollar bet by Biogen, could be headed for a regulatory review. But new trial results are more mixed than the overall outcome suggests.
By Ben Fidler , Ned Pagliarulo • Updated June 15, 2021 -
Courtesy of Novavax
Novavax says vaccine 90% effective against COVID-19 in large trial
Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.
By Ned Pagliarulo • Updated June 14, 2021 -
Vertex stops work on second rare disease drug after study results disappoint
The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.
By Jacob Bell • Updated June 11, 2021 -
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
Beigene expands into cancer cell therapy with Shoreline pact
The fast-growing biotech will work with Shoreline to develop cancer treatments using natural killer cells, an emerging alternative to T-cell based therapies.
By Ned Pagliarulo • June 9, 2021 -
Biogen Alzheimer's approval could open the door for similar drugs
Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.
By Jonathan Gardner • June 9, 2021 -
Permission granted by Biogen
The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.
Officially, Biogen has until 2029 to complete a study confirming Aduhelm's benefit. But the agency says it hopes to push the drugmaker to finish faster.
By Ned Pagliarulo • Updated June 9, 2021 -
AdobeStock.com/Design Cells
Sponsored by IsoPlexisEnabling biomarker discovery with unique functional proteomics
The identification of these novel clinical biomarkers allows researchers to better understand complex mechanisms of immune response to diseases, facilitating the development of more effective therapeutics.
June 7, 2021 -
ASCO21: An immunotherapy debate, an NK cell question and the next precision drugs
Moving immunotherapy to earlier lines of treatment holds promise but, at ASCO, sparked debate, too. Fate Therapeutics, meanwhile, renewed its case for natural killer cell therapy.
By Ben Fidler , Ned Pagliarulo • June 7, 2021 -
Ewa Krawczyk, National Cancer Institute
An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?
New study results could make Lynparza a standard adjuvant treatment for people with an inherited form of breast cancer — as long as they know they have it.
By Ben Fidler • June 3, 2021 -
Novartis prostate cancer drug extends survival in key test of radiopharmaceutical therapy
Results from the Phase 3 trial, which Novartis plans to use to ask for approval, help validate the pharma's bet on the therapy's original developer, Endocyte.
By Ned Pagliarulo • June 3, 2021 -
Courtesy of Sanofi
Sanofi rare disease drug hits another setback
The French pharma halted a late-stage trial of venglustat, one of its priority drug candidates, in a type of kidney disease, months after stopping testing in Parkinson's.
By Ned Pagliarulo • June 1, 2021 -
Getty / Edited by BioPharma Dive
UniQure moves Huntington's gene therapy to next phase of key trial
Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.
By Jonathan Gardner • May 27, 2021 -
'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA
The FDA's decision to approve aducanumb could have far-reaching consequences for patients, Biogen and Alzheimer's research. Here's how the drug's review came about.
By Ned Pagliarulo • May 27, 2021 -
Gabriel Kuchta via Getty Images
Moderna, with new results, set to seek vaccine clearance for young teens
The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.
By Ben Fidler • May 25, 2021 -
Sarah Silbiger via Getty Images
J&J's new cancer drug leads a growing pipeline of dual-targeting antibodies
Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.
By Jonathan Gardner • May 24, 2021 -
A biotech backs off NASH after trial failure
NGM Biopharmaceuticals has decided not to pursue a late-stage NASH program after its drug aldafermin became the latest in a long line of medicines to fail to help patients with the common liver condition.
By Jacob Bell • May 24, 2021 -
iStock.com/vorDa
Sponsored by YourwaySupporting global decentralized and virtual clinical trials during challenging times and beyond
The risks and challenges incurred on clinical trials logistics by the COVID-19 pandemic have significantly accelerated the adoption of DCT and DTP trials models to keep site investigators and potentially vulnerable and immunocompromised patients safe from infection.
By Leandro Moreira, SVP of Corporate Development, Yourway • May 24, 2021 -
iStock.com/FatCamera
Sponsored by PRA Health SciencesAccelerating patient care through digital transformation and decentralized clinical trials
The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs).
May 24, 2021
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