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tag fda business drug development clinical trials

Drug Development: Clinical Trials
Sam Jaffe | May 18, 2003 | 3 min read
5-Prime | Drug Development: Clinical Trials Who gets tested in Phase I Trials? As many as 80 healthy or sick human beings. Phase I trials occur after animal tissue and whole-animal studies have determined that the agent appears safe and effective for its intended use. This stage discerns mainly whether the agent is safe for humans and provides data to determine the pharmacological effects. Phase I studies, which last from two to six months, are observed closely so that the entire trial can
Illustration of light blue neurons with white amyloid plaques accumulating on their axons.
New Alzheimer’s Drug Slows Cognitive Decline in Clinical Trial
Dan Robitzski | Sep 28, 2022 | 2 min read
The Biogen-developed treatment, called lecanemab, appears to have a more clear-cut effect on slowing the disease than the company’s previous Alzheimer’s drug, Aduhelm.
Accelerating new drug development
John Borchardt(JKBdeinker@aol.com) | Jan 29, 2001 | 4 min read
US FDA user fees may have accelerated new drug development but a recent survey suggests difficulties in obtaining volunteers for human clinical trials still slow progress.
An artistic rendering of blue neurons against a white background
Participant’s Diagnosis Halts Gene Therapy Clinical Trial
Amanda Heidt | Aug 12, 2021 | 3 min read
The FDA pauses the research program on a lentivirus-based treatment for a rare neurological condition after a patient developed a bone marrow disorder that could presage leukemia.
a photo of the packaging for the drug Trikafta
FDA Approves New Cystic Fibrosis Drug
Shawna Williams | Oct 24, 2019 | 1 min read
The treatment, Trikafta, increases lung function in most patients with the disease—but comes with a hefty price tag.
Bugs as Drugs to Boost Cancer Therapy
Danielle Gerhard, PhD | Jan 18, 2024 | 7 min read
Bioengineered bacteria sneak past solid tumor defenses to guide CAR T cells’ attacks.
Infographic: The Cost of Drug Development
John D. Loike and Jennifer Miller | Jan 31, 2017 | 1 min read
Expensive clinical trials and few drug approvals can drive up drug prices for consumers.
FDA Approves Clinical Trials to Test Cuban Cancer Vaccine
Bob Grant | Oct 31, 2016 | 2 min read
An early-stage study of the effectiveness of a lung-cancer vaccine developed by scientists in Cuba could start as early as next month.
Updated
Merck research facility in San Francisco
Antiviral Pill Lowers Risks of COVID-19 Hospitalization, Death
Chloe Tenn | Oct 1, 2021 | 3 min read
Merck reports that its antiviral molnupiravir was effective against early stages of COVID-19 in high-risk patients in a Phase 3 clinical trial.
Updated
blue and white sign for the entrance to the FDA that says U.S. Department of Health and Human Services Food and Drug Administration
Biogen’s Alzheimer’s Drug Gets FDA Approval, Mixed Reviews
Kerry Grens | Jun 7, 2021 | 2 min read
A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.

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