Clinical Trials: Page 36
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Sponsored by ICONPractical approaches to operationalizing decentralized clinical trials
When appropriate, DCTs can accelerate trial conduct, create a wealth of high-quality data and improve efficiency.
Aug. 5, 2021 -
FDA allows Novartis gene therapy trials to resume after nearly 2 year pause
After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA.
By Jonathan Gardner • Aug. 3, 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 -
Jeenah Moon via Getty Images
Pfizer's fast progress shines spotlight on an emerging vaccine race
The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.
By Jonathan Gardner • July 30, 2021 -
Permission granted by Biogen
Biogen, Ionis tout data from early study of RNA-based Alzheimer's drug
The companies said that patients treated with their experimental drug BIIB080 had reductions in a protein called tau, which research indicates is tied to Alzheimer's but isn't yet proven to impact the course of the disease.
By Jacob Bell • July 27, 2021 -
Denali drug for rare brain disease disappoints investors
New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts. Company shares fell by 15% Monday morning.
By Jacob Bell • July 26, 2021 -
Seres, after earlier success, fails a key test for microbiome drugs
A pill made of gut bacteria wasn't effective at treating ulcerative colitis in a closely watched study that was viewed as a proof point for the emerging field.
By Ben Fidler • July 22, 2021 -
Elizabeth Regan/BioPharma Dive
Cytokinetics heart drug succeeds in mid-stage study, boosting shares
Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb.
By Ned Pagliarulo • July 19, 2021 -
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Sponsored by YourwayIntegrating sourcing, packaging, labelling and distribution for efficient clinical kitting
Efficient execution of clinical trials requires the provision of medicines and all other critical materials to be carefully delivered on time to clinical sites or patient's homes.
July 19, 2021 -
Permission granted by Clinical Ink
Sponsored by Clinical InkHow real-time data keeps infectious disease studies moving in times of crisis
One COVID-19 study, 1,000 seniors — ahead of schedule. Find out how eSource made it happen.
July 19, 2021 -
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 -
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 -
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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
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