Clinical Trials: Page 24
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CinCor shares dive after blood pressure drug fails key trial
The company, one of several testing a drug for resistant hypertension, had previously pulled off one of the top performing biotech IPOs this year.
By Gwendolyn Wu • Nov. 28, 2022 -
Stock via Getty Images
Axsome says drug eased Alzheimer’s symptom in positive study
Shares of the New York-based biotech rose by a third Monday morning, as fresh clinical trial results showed its drug AXS-05 both delayed and prevented the recurrence of Alzheimer’s agitation.
By Jacob Bell • Nov. 28, 2022 -
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 -
Courtesy of Sarepta
FDA grants speedy review to Sarepta’s Duchenne gene therapy
The agency will decide on an accelerated approval of Sarepta’s treatment by May 29, months before results are expected from a potentially confirmatory Phase 3 trial.
By Jonathan Gardner • Nov. 28, 2022 -
Permission granted by ICON
Sponsored by ICONMainstreaming cell and gene therapy – Realizing its potential
The challenges biopharma companies face in running clinical trials and tips on how to surmount those obstacles.
Nov. 28, 2022 -
Permission granted by Veeva Systems
Sponsored by Veeva SystemsWhy connected systems are the secret sauce for faster, better trials
A holistic approach allows stakeholders to adapt to the ever-increasing number of clinical trials and data points.
By Jodi Helmer • Nov. 21, 2022 -
Permission granted by Editas Medicine
Editas to seek partner for CRISPR medicine after lackluster study results
While the biotech will not develop the gene editing therapy further on its own, CEO Gilmore O’Neill claimed the data are still a meaningful demonstration of what CRISPR can accomplish.
By Ned Pagliarulo • Nov. 17, 2022 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Moderna data supports use of omicron booster over original vaccine
New results show the two-pronged booster the FDA cleared in August sparks a stronger immune response against omicron and its subvariants than Moderna’s original shot.
By Jonathan Gardner • Nov. 14, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Trial failures end latest hope for Roche’s Alzheimer’s drug
Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials.
By Delilah Alvarado , Ben Fidler • Nov. 14, 2022 -
Early data hint at benefit for Amgen’s obesity drug
Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.
By Jonathan Gardner • Nov. 8, 2022 -
Courtesy of GSK
GSK myeloma drug comes up short in confirmatory test
The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020.
By Ned Pagliarulo • Nov. 7, 2022 -
Amgen to test new way to lower heart risk with large drug trial
Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a).
By Ned Pagliarulo • Nov. 7, 2022 -
Jonathan Gardner/BioPharma Dive
Bispecific cancer drugs and gene therapy advances: What to watch at this year’s ASH meeting
Competition is increasing behind newly approved drugs from Roche and J&J, while the long-term benefit of gene therapies for chronic blood disorders is being put to the test.
By Ben Fidler , Ned Pagliarulo • Nov. 4, 2022 -
Getty / Edited by BioPharma Dive
Abeona to submit cell therapy for approval after positive results for skin disorder treatment
The company said its therapy, which could become the first drug for a type of epidermolysis bullosa, helped heal wounds and reduce pain in a clinical trial.
By Jacob Bell • Nov. 3, 2022 -
David Dee Delgado via Getty Images
Pfizer gets first positive result for an RSV vaccine in pregnant women
The shot kept newborns from getting severe respiratory infections in a Phase 3 trial, paving the way for the drugmaker to seek approval before its top rivals.
By Jonathan Gardner • Nov. 1, 2022 -
Permission granted by Bristol-Myers Squibb
With positive trial results, Bristol Myers looks to widen use of blood disease drug
Reblozyl, one of the drugmaker’s key assets, outperformed an older anemia drug in early-stage myelodysplastic syndrome, which could double the number of potentially eligible patients.
By Jonathan Gardner • Oct. 31, 2022 -
RoosterHD via Getty Images
Sponsored by Worldwide Clinical TrialsWhat the FDA’s guidance on diversity means for rare disease sponsors
Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.
Oct. 31, 2022 -
Warren Little via Getty Images
GSK shelves filing plans for arthritis drug after trial results
GSK said the drug, formerly a top prospect licensed from German biotech Morphosys, showed “limited efficacy” in a Phase 3 study of patients with rheumatoid arthritis.
By Delilah Alvarado • Oct. 27, 2022 -
Stock via Getty Images
AstraZeneca extends run of trial successes with breast cancer drug results
On the heels of a major approval for Enhertu, the pharma reported positive results for two experimental drugs in settings where rival medicines from Roche and Sanofi recently failed.
By Ben Fidler • Oct. 26, 2022 -
magicmine, iStock / Getty Images Plus via Getty Images
Vaxcyte rides investor enthusiasm for early pneumococcal vaccine data
Encouraging study results for a vaccine with broader coverage than Pfizer’s Prevnar 20 sent Vaxcyte’s valuation soaring and could make the company a potential takeover target.
By Jonathan Gardner • Oct. 24, 2022 -
Novartis rival to AstraZeneca rare disease drugs succeeds in study
The pharma said iptacopan, one of its top pipeline prospects, outperformed Alexion’s Soliris and Ultomiris in certain patients with a disease called PNH.
By Ned Pagliarulo • Oct. 24, 2022 -
Sarah Silbiger via Getty Images
FDA advisers back withdrawal of controversial drug for preterm birth
A committee of independent experts voted 14-1 that the agency shouldn’t allow the treatment from Covis Pharma to remain on the market while further testing is conducted.
By Jonathan Gardner • Updated Oct. 19, 2022 -
Porpeller via Getty Images
NGM shares plunge as Merck-partnered eye drug fails Phase 2 test
Executives said the biotech could search for a new partner for the geographic atrophy drug if Merck decides not to license it under an existing deal.
By Ben Fidler • Oct. 17, 2022 -
National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
GSK sets high bar with trial results for RSV vaccine
With data expected for several other vaccines for the respiratory disease, GSK reported positive clinical trial results showing efficacy above 80%.
By Jonathan Gardner • Oct. 13, 2022 -
Prapat Aowsakorn via Getty Images
Relmada shares collapse after fast-acting depression drug fails first test
The company blamed a higher-than-expected placebo response for the negative outcome, and is now pinning its hopes on two other trials that are currently underway.
By Ben Fidler • Oct. 13, 2022 -
Permission granted by Vertex Pharmaceuticals
Vertex, after setbacks, moves forward with second-generation rare disease drug
The biotech is starting a trial of a new treatment for alpha-1 antitrypsin deficiency following disappointing study results for two earlier compounds.
By Ned Pagliarulo • Oct. 11, 2022
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