Clinical Trials: Page 29
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Pfizer advances diabetes, obesity drug hopeful into mid-stage testing
The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.
By Kristin Jensen • Dec. 21, 2022 -
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FDA halts planned trial of Entrada Duchenne drug
Shares in the Boston-based biotech fell on the news, which comes shortly after a deal with Vertex around another type of muscular dystrophy.
By Gwendolyn Wu • Dec. 20, 2022 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
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Doubts around cancer drug target persist after Gilead, Arcus study results offer ‘mixed picture’
While long anticipated trial data were technically positive, analysts questioned whether drugs aimed at ‘TIGIT’ will prove a meaningful treatment addition.
By Ned Pagliarulo • Dec. 20, 2022 -
Megan Quinn/BioPharma Dive
Government spending bill would tighten FDA oversight of accelerated drug approvals
The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.
By Jonathan Gardner • Dec. 20, 2022 -
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Madrigal shares triple on positive NASH study results
The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field.
By Jacob Bell • Dec. 19, 2022 -
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Third Harmonic halts study of lead drug over safety risk
The biotech, previously a success story this year, will end development of its chronic hives treatment and search for alternative drug candidates.
By Ned Pagliarulo • Dec. 15, 2022 -
Courtesy of Sanofi
Kymera shares jump on Sanofi’s decision to advance protein-degrading drug
Early data from a small, Phase 1 study exceeded Kymera’s expectations and, the biotech’s CEO claimed, offer “clinical validation” for its scientific approach.
By Ned Pagliarulo • Dec. 14, 2022 -
Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda
The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales.
By Jonathan Gardner • Dec. 13, 2022 -
Courtesy of Rodney White / American Society of Hematology
At ASH, Regeneron plays catch-up with its next cancer drugs
Two bispecific antibodies are “foundational” to the company’s plan to build an oncology business, according to a top executive. But Regeneron will have to surpass a crowd of competitors.
By Ben Fidler • Dec. 12, 2022 -
Courtesy of Matt Herp / American Society of Hematology
J&J’s next myeloma drug, Argenx’s second act and a new question for Bluebird: 3 ASH takeaways
The year’s biggest meeting on blood diseases kicked off this past weekend. Here are three of the most important storylines to emerge from the past few days of presentations.
By Ned Pagliarulo , Ben Fidler • Updated Dec. 12, 2022 -
Adeline Kon/BioPharma Dive
Sponsored by Allucent[Podcast] Thinking Big for Small and Mid-Sized Biotechs
This podcast series explores how to help small and mid-sized companies get innovative treatments to the people who need them.to help small and mid-sized companies get innovative treatments to the people who need them.
By BioPharma Dive's studioID • Updated Dec. 15, 2022 -
Spencer Platt via Getty Images
Pharvaris, pushing through trial pause, sees shares surge with new study results
Though the FDA halted testing of the biotech’s pill for hereditary angioedema in August, enough patients were already enrolled to accrue results that sent shares soaring.
By Ben Fidler • Dec. 9, 2022 -
Novartis gets second trial win for blockbuster hopeful
The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.
By Kristin Jensen • Dec. 8, 2022 -
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Relmada sinks further as depression drug fails second large trial
The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result.
By Ben Fidler • Dec. 8, 2022 -
Elizabeth Regan/BioPharma Dive
Prometheus shares soar on new data for inflammation drug
Having scored positive results in two key studies for ulcerative colitis and Crohn’s disease, Prometheus now intends to advance the drug, called PRA023, into pivotal testing.
By Jacob Bell • Dec. 7, 2022 -
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Esperion, without data, says cholesterol pill lowered heart risk in study
The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.
By Ned Pagliarulo • Dec. 7, 2022 -
Sarah Silbiger via Getty Images
MEI, Kyowa stop lymphoma drug trials after FDA meeting
The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors.
By Jonathan Gardner • Dec. 6, 2022 -
Permission granted by Novartis
Novartis prostate cancer drug succeeds in study key to company’s sales hopes
The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.
By Ned Pagliarulo • Dec. 5, 2022 -
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With new data, Nkarta builds case for ‘natural killer’ cell therapy
The updated study results add to evidence that such therapies may help treat B-cell lymphomas. But it’s still unclear how long their effects could last.
By Ben Fidler • Dec. 5, 2022 -
Yuri Arcurs/Alamy Stock Photo
Sponsored by AllucentWhen it comes to small populations, biotechs need to think big
Maria-Cruz Morillo, global therapeutic operations lead for rare diseases at Allucent, discusses the unique challenges of rare disease drug development and how the right expertise can help.
Dec. 5, 2022 -
Permission granted by Syneos Health
Sponsored by Syneos HealthWe must improve diversity in clinical trials. These 5 steps will help.
The pandemic shined a light on the importance of diversity in clinical trials. Syneos Health can help your team devise a diversity strategy.
Dec. 5, 2022 -
Roche study failure gives Alzheimer’s researchers new clues in drug quest
Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.
By Jonathan Gardner , Delilah Alvarado • Dec. 1, 2022 -
Lilly’s Alzheimer’s drug bests Aduhelm in plaque clearance study
The company's experimental treatment donanemab reduced amyloid levels in the brain by more than Biogen's approved medicine, but the data’s significance is unclear until Lilly reveals results from a larger study next year.
By Ned Pagliarulo • Dec. 1, 2022 -
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What to make of Eisai and Biogen’s Alzheimer’s drug results
At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. Still, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.
By Jacob Bell , Ned Pagliarulo • Nov. 29, 2022 -
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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
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