Clinical Trials: Page 27
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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 -
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 -
Permission granted by Seagen
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 -
magicmine, iStock / Getty Images Plus via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Jose Luis Calvo Martin & Jose Enrique Garcia-Maurino Muzquiz via Getty Images
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 -
Jacob Bell/BioPharma Dive
Jazz drug fails in late-stage study for multiple sclerosis
The drug, part of Jazz’s $7 billion acquisition of GW Pharmaceuticals, didn’t perform significantly better than placebo in treating the muscle spasticity that’s tied to the disease.
By Jacob Bell • Updated June 29, 2022 -
Sanofi, GSK say dual-acting vaccine prevents COVID-19 from omicron in large trial
A shot the partners have been developing reduced symptomatic infections associated with the variant by 72% compared to a placebo, positioning it as a potential option, if approved, to combat omicron.
By Jonathan Gardner • June 24, 2022 -
Courtesy of Sarepta
FDA suspends US testing of Sarepta Duchenne drug over safety concerns
The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.
By Ben Fidler • June 23, 2022 -
Stock via Getty Images
UniQure buoyed by early data for Huntington's gene therapy
After one year, researchers detected important protein changes in patients who received a low dose of the experimental treatment. Further testing and functional data are needed to assess its potential, however.
By Jonathan Gardner • June 23, 2022 -
Permission granted by Biogen
Biogen, citing insurance challenges, shutters one of its Aduhelm studies
The company says a recent coverage decision by Medicare has forced it to end an observational trial of the Alzheimer's drug after enrolling just 29 participants.
By Jacob Bell • June 22, 2022 -
Jose Luis Calvo Martin, Jose Enrique Garcia-Maurino Muzquiz via Getty Images
Mixed results for PTC Duchenne drug put spotlight on EU approval
A confirmatory study of PTC Therapeutics’ muscular dystrophy treatment Translarna missed its main goal, although the company highlighted the trial’s overall positive results.
By Ned Pagliarulo • June 21, 2022 -
Christopher Furlong via Getty Images
Ionis, AstraZeneca claim success for competitor to Alnylam rare disease drug
A medicine at the center of a multibillion-dollar alliance between the two companies passed a major test in transthyretin amyloidosis. Full study details were not disclosed, however.
By Ben Fidler • June 21, 2022 -
Roche Alzheimer's study fails in another setback to a long-tested hypothesis
The failure is an upset not only to Roche, but also a blow to the wider Alzheimer’s research field, which has for years kept focus on a protein called beta amyloid.
By Jacob Bell • June 16, 2022 -
Dan Kitwood via Getty Images
Pfizer study results show Paxlovid benefit less clear in lower-risk patients
A closely watched study missed its goal, failing to prove the antiviral pill’s benefit in a broader population than the high-risk individuals for which it’s currently cleared.
By Ned Pagliarulo • June 15, 2022 -
Courtesy of Pfizer
FDA staff supportive of Pfizer, Moderna COVID vaccines in young children
Agency advisers will weigh data from the companies at a two-day meeting that begins Tuesday with discussion of Moderna’s shot in children and teens aged 6 to 17 years old. Use in kids under 5 will be debated Wednesday.
By Jonathan Gardner , Ned Pagliarulo • June 13, 2022 -
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Sponsored by IconWhat Biotech and Pharma need to consider about decentralized trials
The pandemic motivated sponsors to reimagine decentralized trials and realize the benefits these models deliver.
June 13, 2022 -
Meletios Verras via Getty Images
Vertex, CRISPR strengthen case for pioneering gene-editing treatment
Positive data from 75 patients with either sickle cell disease or beta thalassemia keep the companies’ therapy on track to become the first CRISPR-based treatment submitted to drug regulators, possibly by the end of the year.
By Jacob Bell • June 11, 2022 -
National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
GSK claims first positive Phase 3 result for an RSV vaccine
The British drugmaker now plans to seek approval of what could be the first preventive shot for the common lung infection. However, Pfizer, Johnson & Johnson and Moderna are close behind.
By Jonathan Gardner • June 10, 2022 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
Latest Caribou data add to 'off-the-shelf' cell therapy's durability questions
Three of the six lymphoma patients who received Caribou’s gene editing treatment have relapsed in the latest sign that so-called allogeneic drugs could have trouble matching their CAR-T counterparts.
By Ben Fidler • June 10, 2022
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