Clinical Trials: Page 39
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Merck details an immunotherapy 'milestone' in early breast cancer
Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.
By Ben Fidler • July 15, 2021 -
Permission granted by Celldex
Celldex pins its hopes for a comeback on skin disease drug
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.
By Ben Fidler • July 9, 2021 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
Maddie Meyer via Getty Images
Moderna puts seasonal flu vaccine ambitions to the test
Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus.
By Ned Pagliarulo • July 7, 2021 -
As Arrowhead falters, lungs remain a tough target for RNA drugs
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs.
By Ben Fidler • July 6, 2021 -
Courtesy of Eli Lilly
Lilly, Boehringer say diabetes drug first to succeed in hard-to-treat heart failure
The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval.
By Ned Pagliarulo • July 6, 2021 -
Courtesy of CureVac AG
CureVac vows to seek vaccine approval despite low efficacy in COVID-19 study
Final results from CureVac's large Phase 3 study showed an overall efficacy of just 48%, although the German biotech emphasized stronger protection against more severe disease and in younger adults.
By Ned Pagliarulo • July 1, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Roche partner sees promise for anti-COVID 19 pill in early study
A pill from Atea Pharmaceuticals rapidly reduced the amount of virus in the blood of patients with COVID-19, a step forward in drugmaker efforts to develop easier-to-take treatments for the disease.
By Kristin Jensen • June 30, 2021 -
Pfizer's neuroscience spinout scores in schizophrenia
Cerevel Therapeutics on Tuesday revealed positive results from an early-stage study of one of its drugs, doubling the price of the company's stock.
By Jacob Bell • June 29, 2021 -
Courtesy of Gilead Sciences
Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment
A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.
By Ned Pagliarulo • June 28, 2021 -
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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 -
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
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