Clinical Trials: Page 39
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Elizabeth Regan/BioPharma Dive
Small biotech gets big win on treatment for rare swelling disorder
An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.
By Jonathan Gardner • Feb. 9, 2021 -
Courtesy of AstraZeneca
New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa
South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against the variant that's spread throughout the country.
By Ben Fidler • Feb. 8, 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 -
Shutterstock.com/Lightspring
Sponsored by PSI CROOn target, on-time enrollment, even in a global pandemic
Completing enrollment of a phase 3 trial on-time, even through the height of COVID-19
Feb. 8, 2021 -
Jacob Bell/BioPharma Dive
PTC aims again for FDA review of Duchenne drug despite latest miss
The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.
By Jonathan Gardner • Feb. 5, 2021 -
UK to start study testing Pfizer, AstraZeneca vaccines together
The government-funded trial will evaluate the effects of mixing vaccines and varying timing between shots.
By Kristin Jensen • Feb. 4, 2021 -
Microgen/Shutterstock.com
Sponsored by OracleBreaking down the barriers to decentralized trials
Decentralized trials are here to stay. Here's how technology has and will continue to pave the way.
By Henry McNamara, Senior Vice President and General Manager of Oracle Health Sciences • Feb. 1, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen study data bolster prospects of KRAS-blocking cancer drug
Results from a mid-stage study showed Amgen's drug, sotorasib, shrank tumors in over a third of lung cancer patients, affirming earlier findings.
By Ned Pagliarulo • Updated Jan. 29, 2021 -
Courtesy of Eli Lilly
Lilly allies with Vir, GSK as coronavirus variants raise worries about antibody drugs
The emergence of new variants has made antibody drug combinations, which are harder for the virus to evade, more important and led to a unique partnership between a trio of drugmakers.
By Ben Fidler • Jan. 27, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Can new Regeneron, Lilly data move the needle for COVID-19 antibody drugs?
The results show that drugs from both companies can help prevent or treat COVID-19 when given at the right time. But that won't mean much if barriers to use remain high.
By Ben Fidler • Jan. 26, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
J&J says study data on coronavirus vaccine due 'early next week'
Results from the large Phase 3 trial are highly anticipated. If proven effective, J&J's shot could provide much-needed reinforcements to a constrained immunization effort.
By Ned Pagliarulo • Jan. 26, 2021 -
Jacob Bell/BioPharma Dive
AstraZeneca, with new data, claims its leukemia drug is safer than Imbruvica
A head-to-head study showed Calquence and Imbruvica benefited patients similarly, but AstraZeneca's drug had fewer heart-related side effects.
By Jonathan Gardner • Jan. 25, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Moderna to study vaccine booster aimed at coronavirus variant
Laboratory tests indicated the biotech's shot would still protect against virus variants detected in the U.K. and South Africa, although the latter appeared to result in a weaker immune response.
By Ned Pagliarulo • Jan. 25, 2021 -
Merck stops coronavirus vaccine development in surprise setback
The drugmaker, one of the largest vaccine developers, won't move forward with two candidates it's been testing after disappointing data in early trials.
By Ben Fidler • Jan. 25, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain
Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19
By Ned Pagliarulo • Jan. 20, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
Pfizer, BioNTech say vaccine effective against fast-spreading UK coronavirus variant
BioNTech's CEO has also promised data will soon be available on the shot's protection against a South African variant that's worried public health experts.
By Jonathan Gardner • Jan. 20, 2021 -
Biohaven adds to a long list of Alzheimer's drug failures
A study evaluating brain function in patients with mild to moderate Alzheimer's found no statistical difference between Biohaven's drug and a placebo.
By Jacob Bell • Jan. 19, 2021 -
Kendall Davis/BioPharma Dive
10 key clinical trials to watch in the first half of 2021
Study results could come soon for several coronavirus vaccines, as well as experimental medicines from Amgen, Vertex and Sage Therapeutics.
By Ben Fidler • Jan. 11, 2021 -
Monty Rakusen via Getty Images
Sponsored by CovanceAnalysis of success metrics from a risk-based quality management (RBQM) approach to clinical trial management
Gain increased study efficiency and quality with risk-based quality management.
Jan. 11, 2021 -
Pfizer beats Sarepta to start of first late-stage Duchenne gene therapy trial
Sarepta, though, may try to seek accelerated approval using Phase 2 data that's due imminently, along with results from another, smaller trial.
By Jonathan Gardner • Jan. 7, 2021 -
Amgen's asthma drug takes a hit, making for stiffer competition with Regeneron
Just a month after finding success in a Phase 3 trial, Amgen's tezepelumab has come up short in a different study that some analysts think will give an upper hand to Regeneron's Dupixent.
By Jacob Bell • Dec. 22, 2020 -
With biosimilars looming, Roche makes case for new biologic eye drug
Twelve-week dosing for faricimab would help Roche's competitive position, but copycat drugs for existing treatments could soon flood the market.
By Jonathan Gardner • Dec. 21, 2020 -
FDA panel endorses Moderna's coronavirus vaccine
A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the FDA within days.
By Ned Pagliarulo • Updated Dec. 17, 2020 -
With trial plans, Novo wagers its diabetes drug can help treat Alzheimer's
Similar diabetes drugs from Novo have shown signs of promise in treating dementia. The Danish biotech is now putting that hypothesis to the test.
By Jonathan Gardner • Dec. 16, 2020 -
FDA scientists back safety, efficacy of Moderna's coronavirus vaccine
A review by agency staff affirmed the strongly positive results Moderna reported from a large Phase 3 study, clearing the way for a possible emergency authorization in the coming days.
By Ned Pagliarulo • Dec. 15, 2020 -
Regeneron pauses studies of a key cancer drug, citing safety concerns
The FDA flagged a high rate of cytokine release syndrome, a potentially dangerous side effect, in trials of a lymphoma drug Regeneron is developing.
By Kristin Jensen • Dec. 15, 2020
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