Clinical Trials: Page 40
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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 -
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 -
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 -
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 -
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.
Dec. 7, 2020 -
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. 5, 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. 5, 2020 -
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. 2, 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. 1, 2020 -
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 -
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 -
UniQure's gene therapy for hemophilia B meets goal in key study
The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels.
By Ned Pagliarulo • Nov. 19, 2020 -
New AstraZeneca data offer latest hint coronavirus vaccines may protect elderly
Results published Thursday add to hopes the experimental shots now in testing won't only work for young, healthy people. More details are needed, though.
By Ben Fidler • Nov. 19, 2020 -
Permission granted by University of Maryland School of Medicine
New coronavirus vaccine data bolster Pfizer, BioNTech claims of strongly effective shot
Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just eight for those who were vaccinated.
By Ned Pagliarulo • Nov. 18, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Trial success for 2 coronavirus vaccines backs up early research bets
Positive data from Pfizer and Moderna offer the strongest validation yet of researchers' approach to coronavirus vaccines, but leave several questions still unanswered.
By Ned Pagliarulo , Ben Fidler • Nov. 17, 2020 -
Stem cell therapy for ALS fails a large clinical trial
The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.
By Jacob Bell • Nov. 17, 2020 -
Moderna says vaccine prevents COVID-19 in large study, adding to hopes for several protective shots
Multiple effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely.
By Ben Fidler • Nov. 16, 2020 -
Anusorn Nakdee via Getty Images
Sponsored by AltasciencesLigand binding program considerations – the value of preclinical to clinical bioanalytical expertise
Careful selection of a partner CRO can deliver advantages and accelerate your drug development program.
Nov. 16, 2020 -
Sturti via Getty Images
Sponsored by SAP5 reasons life sciences needs better clinical trial supply management
A new industry consortium is lining up stakeholders to work together to address long-standing pain points that disrupt clinical trials.
Nov. 16, 2020
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