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Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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AT-527, an oral direct-acting antiviral agent that blocks viral RNA polymerase needed for viral replication, failed to meet its primary endpoint in the Phase II MOONSONG study.
With the Delta variant of coronavirus spreading globally, the pandemic still has a tight grip on the world. Many people around globe are struggling to come to terms with the aftermath of the pandemic, much like a century ago with the Spanish flu.
On Monday, LogicBio Therapeutics unveiled clinical trial results demonstrating the first-ever in vivo, nuclease-free genome editing in little humans.
SURPASS-4 is part of the Phase III trial evaluating tirzepatide as a possible treatment for type 2 diabetes.
FDA
Zimhi is indicated for use in both adults and children in the event of an emergency. It is to be given right away and does not take the place of emergency care.
Products getting regulatory approval and hitting the market doesn’t always spell success for companies, especially during a global pandemic. Michigan-based Esperion has learned that lesson all too well.
While it has yet to reach clinical trials, preclinical results with the company’s specially-tailored adeno-associated virus have been fortuitously auspicious.
Flu season is here and overall viral activity is up 23% across the United States, even as respiratory syncytial virus and COVID-19 infections continue to sweep across parts of the nation.
It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.
The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.