Clinical Trials
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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.
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Explore the Trendline➔
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
TrendlineInside the global race for a coronavirus vaccine
Some 29 vaccine candidates are now in clinical studies. Early results from five leading efforts are encouraging, suggesting researchers are on the right track despite rapid acceleration of testing.
By BioPharma Dive staff -
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. 07, 2021 -
Amgen Inc.
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 -
Courtesy of Roche
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 -
Moderna
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 at 6:02 p.m. -
Novo Nordisk
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 -
Moderna
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
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 -
GlaxoSmithKline
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 -
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 at 10:32 a.m. -
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. 09, 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 at 7:01 p.m. -
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. 09, 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. 08, 2020 -
Courtesy of BioNTech
FDA scientists appear supportive of Pfizer, BioNTech's coronavirus vaccine
Agency staff didn't raise any red flags in their review of the companies' study results, documents released ahead of a key advisory committee meeting Thursday show.
By Ned Pagliarulo • UPDATED: Dec. 8, 2020 at 2:48 p.m. -
Ivan-balvan & zorazhuang via Getty Images
Sponsored by AltasciencesAltasciences' comprehensive, integrated solution for clinical supply manufacture
Integrated CRO/CDMO solutions for accelerated and more efficient early drug development programs.
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J&J study finds multiple myeloma cell therapy to be strongly effective
Safety issues that have dogged the CAR-T field remain, however, with the drugmaker reporting some severe side effects, including several that led to patient deaths.
By Jonathan Gardner • Dec. 05, 2020 -
Getty / Edited by BioPharma Dive
A CRISPR gene editing treatment continues to show promise for two blood diseases
Results from 10 patients with beta thalassemia or sickle cell disease show CRISPR Therapeutics and Vertex's pioneering treatment to be effective, building on earlier study data.
By Ben Fidler • Dec. 05, 2020 -
Getty
Ovid's plan to prove a shelved sleeping pill for a rare disease ends in disappointment
A quest by former Teva and Bristol Myers executive Jeremy Levin to develop an old drug for Angelman's syndrome fell short in a late-stage clinical trial.
By Ben Fidler • Dec. 02, 2020 -
With anemia data, Agios blood disease drug takes a crucial step forward
Phase 3 results announced Tuesday boost chances that Agios' drug might not just win approval for a rare type of anemia, but also be useful in treating other blood diseases.
By Ben Fidler • Dec. 01, 2020 -
Moderna
Moderna, finishing key study, to ask FDA for emergency approval of coronavirus vaccine
New results confirm the shot's strong efficacy against COVID-19 and should raise confidence vaccination can prevent against severe symptoms as well.
By Ben Fidler • Nov. 30, 2020 -
Courtesy of AstraZeneca
AstraZeneca, Oxford vaccine prevents COVID-19, though study results raise questions
Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19 — an encouraging finding. The lower dose tested, however, unexpectedly outperformed a higher dose.
By Ben Fidler • UPDATED: Nov. 23, 2020 at 10:20 a.m. -
Permission granted by Gilead Sciences
WHO recommends against Gilead's Veklury, in break with US guidelines
The organization argues there's no evidence the antiviral saves lives or improves outcomes for COVID-19 patients, despite positive data on the latter point from a key U.S. study.
By Jonathan Gardner • Nov. 20, 2020
