Clinical Trials: Page 27
-
Permission granted by Biogen
Biogen, Eisai data raises hope for other experimental Alzheimer’s drugs
Expectations are now higher for amyloid-clearing drugs from Eli Lilly and Roche after lecanemab showed it can slow the disease’s progression in a large Phase 3 clinical trial.
By Jonathan Gardner • Sept. 28, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
New Alzheimer's drugsIn surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial
The companies’ drug lecanemab met all of its goals in the Phase 3 study. The data were a significant finding and provided stronger support for a much-debated hypothesis for treating Alzheimer’s.
By Jonathan Gardner • Updated Sept. 27, 2022 -
Explore the Trendline➔
Getty Images
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 -
Getty Images
Sponsored by MedscapeHealth equity: the current environment and a path to improvement
Over the last 2 years, a greater spotlight has shone on inequalities in health care, and the greater need to improve health equity.
Sept. 26, 2022 -
Getty Images
Pfizer, Sangamo set to resume gene therapy study after safety delay
Concerns over blood clotting risk had derailed testing of the hemophilia treatment last year, leading the companies to adjust their trial protocol.
By Delilah Alvarado • Sept. 23, 2022 -
Getty Images
AstraZeneca gives up on Ionis’ RNA drug for heart disease
The British drugmaker decided the medicine, which works similarly to Novartis’s Leqvio, wasn’t potent enough to justify further testing.
By Jonathan Gardner • Sept. 23, 2022 -
Kena Betancur via Getty Images
Merck to resume testing of closely watched HIV drug, but at lower dose
Safety concerns had derailed a slate of studies involving the drug, called islatravir, last fall. A partial FDA hold remains on any study using a higher dose.
By Ned Pagliarulo • Sept. 20, 2022 -
Christopher Furlong via Getty Images
AstraZeneca claims positive results for its “add-on” drug for rare blood disease
The drug, meant to complement other treatments for paroxysmal nocturnal hemoglobinuria, comes via Alexion, which had acquired it from Achillion in 2019.
By Delilah Alvarado • Sept. 16, 2022 -
Courtesy of Intellia Therapeutics
Intellia offers first look at CRISPR drug for rare swelling disorder
Preliminary study results show the biotech’s gene editing treatment could reduce markers and symptoms of hereditary angioedema, though the data come from few patients and follow-up remains limited.
By Ben Fidler • Updated Sept. 16, 2022 -
Spencer Platt via Getty Images
Pfizer reports success in trial of all-in-one meningitis vaccine
The company is planning an FDA submission as it works to expand its vaccine business beyond top-selling shots for COVID-19 and pneumonia.
By Jonathan Gardner • Sept. 15, 2022 -
Getty Images
Akero shares soar as NASH drug succeeds in mid-stage trial
The biotech’s experimental medicine meaningfully improved multiple signs and symptoms of patients with NASH, a common liver disease that's proven a tough target for several drugmakers.
By Ben Fidler • Sept. 13, 2022 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen data supports KRAS cancer drug, but survival benefit remains in question
Results from the company’s Phase 3 study show Lumakras outperformed chemotherapy. But that effect didn’t translate into patients living longer.
By Ned Pagliarulo • Sept. 12, 2022 -
Sarah Silbiger via Getty Images
FDA names new head to vaccine review office
David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.
By Jonathan Gardner • Sept. 9, 2022 -
Regeneron answers rivals with data for new version of top-selling eye drug
A high-dose form of Eylea, administered less frequently, matched the original in late-stage testing, an important step in the company’s plan to defend its bestseller against competition.
By Ben Fidler • Sept. 8, 2022 -
Permission granted by Gilead Sciences
Gilead says its breast cancer drug helped patients live longer in study
The data could help Trodelvy secure a place in treatment, although a rival drug from Daiichi Sankyo and AstraZeneca will offer strong competition.
By Jonathan Gardner • Sept. 8, 2022 -
Permission granted by Relay Therapeutics
Relay impresses with early study data for targeted cancer drug
Updated data released ahead of the ESMO medical conference suggest Relay’s medicine could be more effective than others like it in treating a type of bile duct cancer.
By Ned Pagliarulo • Sept. 8, 2022 -
Alnylam details anticipated results from heart disease drug trial
Fuller data from the APOLLO-B study confirm the success reported by Alnylam last month, but won’t end debate on the magnitude of the drug’s benefit.
By Ben Fidler • Sept. 8, 2022 -
Getty Images
Iveric readies eye drug for FDA following study success
The drug slowed eye lesion growth in people with geographic atrophy, positioning it to become the second treatment for the disease to reach the FDA.
By Ben Fidler • Sept. 6, 2022 -
Courtesy of Sarepta
Sarepta to restart Duchenne drug study after FDA lifts hold
The biotech will expand patient monitoring in response to a previously reported serious adverse reaction that had led the FDA in June to suspend testing.
By Ned Pagliarulo • Sept. 6, 2022 -
Amgen says KRAS drug beat chemo in lung cancer study
But the company offered no details on the closely watched trial, which is meant to confirm the effectiveness of Lumakras in non-small cell lung cancer.
By Ned Pagliarulo • Aug. 31, 2022 -
Getty Images
Jounce’s latest setback dampens outlook for another cancer immunotherapy target
The biotech's drug prospect vopratelimab has become the latest member of a group of medicines targeting a molecule called ICOS to fall short of expectations in clinical testing.
By Jonathan Gardner • Aug. 30, 2022 -
AstraZeneca, matching Lilly, reports positive heart failure data for diabetes pill
The new data position AstraZeneca to significantly expand use of Farxiga in heart failure and compete with Lilly and Boehringer Ingelheim’s rival drug Jardiance.
By Jonathan Gardner • Aug. 29, 2022 -
Getty Images
Bristol Myers, Bayer study results seed doubt about an emerging group of blood thinners
Though the companies plan to move their medicines into late-stage testing, they each missed their main Phase 2 goals, raising questions about the prospects of so-called Factor XI inhibitors.
By Christopher Newman • Aug. 29, 2022 -
Getty Images
Sponsored by Worldwide Clinical TrialsPsychedelic clinical trials: What sponsors should know when designing new protocols
With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.
Aug. 29, 2022 -
Spencer Platt via Getty Images
Pfizer follows GSK with positive Phase 3 results for RSV vaccine
In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.
By Delilah Alvarado • Aug. 25, 2022 -
Getty Images
Safety worries spur Novartis to suspend drug dosing in Huntington’s trial
Researchers reported signs of nerve damage in patients treated with the drug branaplam, which is among the most advanced candidates now in testing.
By Jonathan Gardner • Aug. 24, 2022
Previous
