Clinical Trials: Page 28
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Biotech Erasca taps MD Anderson to help advance cancer drug work
The five-year partnership is one of many inked between the cancer center and drugmakers like Erasca, which is targeting a cellular pathway linked to many types of tumors.
By Christopher Newman • Aug. 23, 2022 -
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Pharvaris studies of rare disease drug put on hold by FDA
The agency suspended two trials of Pharvaris’ experimental treatment for hereditary angioedema after reviewing nonclinical data, the biotech said.
By Ned Pagliarulo • Aug. 22, 2022 -
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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 -
CSL says drug for rare swelling disorder succeeds in late-stage study
The company plans to soon seek approval of a once-monthly preventive drug for hereditary angioedema, a disease other drugmakers are targeting with gene editing and RNA medicines.
By Kristin Jensen • Aug. 18, 2022 -
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Blueprint drug succeeds in rare disease study important to its market prospects
Trial results position the company to seek approval for indolent systemic mastocytosis, which executives have painted as a “multibillion dollar” market opportunity. Even so, shares fell by double digits in trading Wednesday.
By Ben Fidler • Updated Aug. 17, 2022 -
Elizabeth Regan/BioPharma Dive
Ventyx touts early data for potential rival to Bristol Myers psoriasis drug
The biotech plans to start Phase 2 studies for a drug it believes may more effectively hit its target than Bristol Myers’ deucravacitinib, a skin disease treatment regulators could approve next month.
By Jonathan Gardner • Aug. 16, 2022 -
Novartis bid to repurpose rare disease drug for cancer falls short in third trial
A study testing Novartis’ canakinumab as an adjuvant lung cancer treatment missed its main goal, closing off an opportunity for an expanded approval.
By Ned Pagliarulo • Aug. 15, 2022 -
Courtesy of Bristol Myers Squibb
Bristol Myers claims success in study testing earlier CAR-T use in multiple myeloma
Abecma, which 2Seventy bio helps develop and sell, is currently approved for patients who have tried at least four other medicines for the blood cancer.
By Ned Pagliarulo • Aug. 10, 2022 -
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Pfizer, Valneva take next step with Lyme disease shot, starting large trial
The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.
By Delilah Alvarado • Aug. 9, 2022 -
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Fresh off Enhertu success, AstraZeneca and Daiichi claim progress for next cancer drug
A treatment that AstraZeneca acquired for up to $6 billion in 2020 is showing early promise as a combination agent in lung cancer, where it’s being tested alongside Merck & Co.’s Keytruda.
By Ben Fidler • Aug. 9, 2022 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen data on KRAS cancer drug disappoints, opening door for rival Mirati
Highly anticipated trial results for Lumakras combinations with immunotherapy fell short of expectations, showing significant liver toxicity that limited dosing.
By Ned Pagliarulo • Aug. 8, 2022 -
Courtesy of Eli Lilly
Lilly takes long view on Alzheimer’s drug as FDA starts expedited review
The pharma said Thursday the FDA had accepted its application for donanemab, starting a six-month evaluation for accelerated approval.
By Ned Pagliarulo • Aug. 5, 2022 -
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Alnylam drug succeeds in key heart disease study, boosting company
The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on an approval application.
By Ben Fidler • Aug. 3, 2022 -
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Sponsored by Janssen PharmaceuticalsThe promise of oral therapies for cytokine inhibition
The science behind new oral therapies for cytokine inhibition and why they could be transformational for patients.
By David Lee, Global Therapeutic Area Head, Immunology • Aug. 1, 2022 -
Alnylam reveals longer wait for anticipated drug trial results
Important data from the APOLLO study of the biotech's drug Onpattro are due before the end of August, Alnylam said Thursday.
By Ned Pagliarulo • July 28, 2022 -
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Pfizer, BioNTech to study 'bivalent' booster as FDA weighs approach
The small-scale study is part of the companies’ efforts to update their vaccine in time for a potential fall vaccination campaign to help boost waning immunity.
By Christopher Newman • July 27, 2022 -
Elizabeth Regan/BioPharma Dive
BridgeBio advances drug for dwarfism after study data
The highest tested dose of BridgeBio’s drug helped the bones of children with achondroplasia grow faster, leading the company to expand study enrollment.
By Ned Pagliarulo • July 26, 2022 -
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Seagen, Astellas claim positive results in study key to cancer drug's success
The mid-stage trial tested the companies’ drug Padcev with Merck’s Keytruda in first-line bladder cancer. The data are reportedly a factor in Merck’s talks with Seagen over a potential buyout.
By Ned Pagliarulo • July 26, 2022 -
Vertex to move non-opioid painkiller into late-stage tests after FDA agreement
Trial results released earlier this year showed potential for the drug, which has become one of Vertex’s top pipeline prospects.
By Delilah Alvarado • July 22, 2022 -
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Atara shares sink after update on multiple sclerosis trial
Much-anticipated interim results from Atara’s Phase 2 study revealed little about the likelihood of the trial’s success, spurring a market sell-off.
By Ned Pagliarulo • July 13, 2022 -
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With new data, Pliant drug shows promise in tough-to-treat lung disease
The drug’s potential impact on the lung health of idiopathic pulmonary fibrosis patients, many of whom take medicines from Roche and Boehringer Ingelheim, came as a “surprise” given the study’s small size, according to one analyst.
By Ben Fidler • July 11, 2022 -
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New analysis encourages Intercept to refile NASH drug for approval
The company said the new examination is more “in line” with FDA guidance and still found that its drug, known as OCA, helped reduce liver scarring.
By Jacob Bell • July 7, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug
The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.
By Jonathan Gardner • July 6, 2022 -
Kendall Davis/BioPharma Dive
Deep Dive10 clinical trials to watch in the second half of 2022
The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump endures.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • July 5, 2022 -
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Celldex, continuing comeback, adds to early promise for skin disease drug
New study results show the medicine appears as effective, or stronger, than standard care for chronic urticarias, a common condition that drugs from Regeneron and Novartis have struggled to treat.
By Ben Fidler • July 1, 2022 -
Courtesy of Sanofi
FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects
Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.
By Jonathan Gardner • June 30, 2022
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