Clinical Trials: Page 35
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Nastasic via Getty Images
Sponsored by Koneksa HealthThe time is ripe for wearables in oncology clinical trials and cancer treatment
Wearables can minimize trips to clinic sites and may provide study participants and cancer patients with a feeling of having more control over how they manage their own illness.
June 28, 2021 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
Deep DiveIntellia, with first results, delivers a 'landmark' for CRISPR gene editing
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.
By Ben Fidler • June 26, 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 -
FDA advisers vote down Incyte cancer drug as agency takes tougher line
The committee voted 13-4 to recommend the FDA wait for more clinical trial data from Incyte, which is aiming to win approval for what would be the eighth PD-1 or PD-L1 inhibitor.
By Ned Pagliarulo • June 25, 2021 -
Arcus claims positive study results for lung cancer drug, but shares no details
The lack of specific data frustrated analysts, but shares in Arcus rose by double digits Thursday. Partner Gilead is expected to make a decision on whether to license the drug later this year.
By Kristin Jensen • June 24, 2021 -
Getty / Edited by BioPharma Dive
A year after getting UniQure's gene therapy, hemophilia patients are still doing better
New results from a key study show the treatment's benefit is holding up well over time. But the FDA wants to see more data, delaying when UniQure and partner CSL expect to file for approval.
By Jacob Bell • June 22, 2021 -
Merck says Keytruda extends survival in cervical cancer study
Results from a Phase 3 study could help Merck secure a full approval for use of Keytruda in the tumor type, potentially extending the therapy's edge over rival therapies.
By Jonathan Gardner • June 22, 2021 -
Long-term Zolgensma data backs up gene therapy's use in youngest patients
With more and more states screening for SMA at birth, the study results are important for assessing Zolgensma's benefits when given very early on.
By Jonathan Gardner • June 21, 2021 -
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 -
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
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