Clinical Trials: Page 41
-
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 -
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 -
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 -
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 -
Permission granted by IQVIA
Sponsored by IQVIAOvercoming barriers to patient adherence
In-home phlebotomy services support therapy initiation and maintenance throughout the patient journey.
By Robyn Stoy, Director, Patient Engagement, Contract Sales and Medical Solutions, IQVIA • Dec. 14, 2020 -
Sanofi, GSK coronavirus vaccine delayed after early study disappoints
The experimental shot produced a weak immune response in adults over 49, leading the partner drugmakers to change plans and push back their development timelines.
By Ben Fidler • Dec. 11, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval
In a statement Friday, FDA Commissioner Stephen Hahn said the agency would "rapidly work toward finalization and issuance" of an authorization for the shot.
By Ned Pagliarulo • Updated Dec. 11, 2020 -
Lilly reports strong results for next-generation diabetes drug
Tirzepatide appears very effective at lowering blood sugar, a boost to Lilly's efforts to fend off Novo Nordisk. But the side effects to treatment will need to be closely watched.
By Jonathan Gardner • Dec. 9, 2020 -
Courtesy of BioNTech
A play-by-play of the historic FDA meeting on Pfizer and BioNTech's coronavirus vaccine
A panel of vaccine and infectious disease experts met Thursday to public vet the drugmaker's study results, eventually voting 17-4 in support of the vaccine after nearly nine hours of discussion.
By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • Updated Dec. 9, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Dive Awards
Researchers of the Year: The RECOVERY team
The U.K.'s RECOVERY trial proved a cheap steroid could keep COVID-19 patients from dying, and showed two other widely considered drugs didn't work — crucial findings in a sprawling, global hunt for coronavirus treatments.
By Jonathan Gardner • Dec. 9, 2020 -
In multiple myeloma, cell therapies lead but antibody drugs could follow fast
Two cell therapies might soon be approved for the blood cancer. But a growing group of antibody drugs, several of which were showcased at ASH, aren't far behind.
By Jonathan Gardner , Ben Fidler • Dec. 8, 2020
Previous
