Clinical Trials: Page 29
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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 -
Explore the Trendline➔
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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 -
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 -
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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 -
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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 -
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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 -
Alnylam follows rivals with new study results for kidney disease drug
An experimental medicine the company is developing with Regeneron has shown early promise treating IgA nephropathy, a disease that’s become a competitive target among drugmakers.
By Jonathan Gardner • June 9, 2022 -
Moderna says 'bivalent' booster sparks stronger immune response against omicron
The biotech claims study results could position its reformulated vaccine as a booster in the fall, though it’s unclear how well the shot can prevent sickness caused by omicron or newer strains of the variant.
By Kristin Jensen • June 8, 2022 -
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Roche keeps the faith in new cancer immunotherapy despite trial setbacks
An ambitious development plan has so far resulted in two late-stage disappointments, but the Swiss drugmaker remains confident there's more to come from its combination treatment.
By Jonathan Gardner • June 7, 2022 -
Courtesy of American Society of Clinical Oncology / Todd Buchanan
ASCO 2022: Gilead's tough weekend, bispecific progress and 'gamma delta' cell therapy
The biotech's highly anticipated breast cancer data were upstaged by a rival, while presentations from Roche, J&J and Adicet Bio highlighted emerging alternatives to CAR-T treatment.
By Ben Fidler , Ned Pagliarulo • June 6, 2022 -
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'Dramatic' study results for AstraZeneca, Daiichi drug suggest new way to treat aggressive breast cancer
A quarter century after Roche's Herceptin became an option for HER2-positive breast cancer, positive study results for Enhertu could push doctors to consider a new classification of "HER2 low" disease.
By Ben Fidler • June 5, 2022 -
Justin Sullivan via Getty Images
Detailed study data show modest benefit to Gilead breast cancer drug
Gilead previously said the closely watched study succeeded but hadn’t shared specifics, raising questions about the effect of the treatment, called Trodelvy.
By Jacob Bell • June 4, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers' autoimmune drug shows potential in lupus
Positive Phase 2 results could help boost company executives' arguments that the drug, called deucravacitinib and under FDA review in psoriasis, will become a top-seller.
By Jonathan Gardner • June 1, 2022 -
Permission granted by Biogen
Sage, Biogen drug meets goal in postpartum depression study
The results will help support an application for FDA approval, which the companies plan to submit early next year. They are already seeking an OK for their treatment in major depressive disorder.
By Ned Pagliarulo • June 1, 2022 -
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Adicet data hints at early promise for 'gamma delta' cell therapy
Four of six lymphoma patients in a small trial went into remission, an early but encouraging sign for an emerging form of cellular immunotherapy.
By Ben Fidler • May 27, 2022 -
Erik S. Lesser via Getty Images
Merck study results signal blood cancer potential for new type of immunotherapy
Bristol Myers beat Merck to the first approval of a so-called LAG-3 inhibitor. But Merck is advancing its own and data to be presented at ASCO show it could help treat Hodgkin's lymphoma.
By Jonathan Gardner • May 26, 2022 -
Retrieved from National Cancer Institute on September 27, 2019
Mirati matches Amgen with updated data for KRAS-blocking cancer drug
Fresh study results showed similar rates of response and progression-free survival with Mirati's experimental adragasib as with Amgen's approved Lumakras. The new data might raise safety questions, however.
By Ned Pagliarulo • Updated May 27, 2022
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