Japanese pharmaceutical company Shionogi has announced the first peer-reviewed publication of its phase 3 study investigating ensitrelvir to treat patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam.
The thin-film freezing specialist reports positive safety and pharmacokinetic data coming out of the Phase I trial of its niclosamide inhalation powder.
The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.
The pharmaceutical company has agreed to provide its Paxlovid oral COVID-19 treatment to the global charity, covering 95 low- and middle-income countries.
The pharma company is evaluating its Paxlovid oral treatment, intended for high-risk patients who have tested positive for the virus, in pediatric subjects.
The pharmaceutical company, which uses thin-film freezing to develop inhalable therapies, has completed enrollment in the first phase for its drug candidate.
The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.
The World Health Organization has recommended the drugs for COVID-19 patients, broadening the range of therapies to combat the virus behind the pandemic.
The pharma firm and collaborator Molecular Partners reported positive data out of their Phase II study for ensovibep, an antiviral for treating the virus.
The US agency continues to work with industry professionals on vaccines and treatments for the virus, and to wrestle with current and emerging variants.
According to the company, the latest Phase II/III study results show its novel oral treatment candidate is effective in reducing hospitalizations and deaths.
The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.
According to a recent survey from Oracle Health Sciences, 97% of trial professionals say newly adopted approaches will stay in use as we move beyond COVID-19.
Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.
An epidemiologist from the healthcare data specialist offers perspective on how real-world data can help get to the heart of long-lasting COVID research.
According to the firm, infectious-disease research advancements could be applied to discovering treatments for millions of hepatitis patients globally.
The US agency plans to use the software firm’s Lighthouse technology to improve understanding of COVID-19 and other conditions in long-term care facilities.
The pharma firm reports molnupiravir was shown to cut risk of hospitalization or death by 50% compared to placebos in a positive interim Phase III analysis.
The protease inhibitor PF-07321332 (co-administered with ritonavir) is designed for patients exposed to (or showing the first signs of) the COVID-19 virus.
As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.
The pharma tech firm has forged a four-year partnership with the foundation to develop antivirals for COVID-19 and other viruses with pandemic potential.
A leader from ACG Engineering shares insight on how ‘smart’ drug manufacturing, accelerated by COVID-19, can best be put to work now and in months to come.
The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike.
A leader from the trial tech firm discusses the pandemic’s impact on studies, and how decentralized technology will be vital in helping industry recovery.
A leader from the rare and infectious disease treatment specialist talks about ongoing research into a potential treatment for mild-to-moderate COVID-19.
The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.
The check-in with nearly 1,800 US healthcare consumers reflects how COVID-19 and other factors have impacted patient access, equity, experience and trust.
The World Health Organization’s Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.
The Heart of Athletes study, using Deloitte’s ConvergeHealth MyPath for Clinical platform, aims to examine heart inflammation in athletes with the virus.
The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products.
The University of Illinois at Chicago has been given $6m from the US Department of Defense to develop a potential treatment for severe cases of COVID-19.
Producers of CPhI North America 2021 offer a glimpse at programming, including sessions on COVID-19 challenges, supply chain issues, and more key topics.
An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.
A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges.
A recent study indicates patients taking the cholesterol-lowering drugs prior to COVID hospitalization are far less likely to die as a result of the virus.
The latest information coming from the agency includes news on drug shortages related to the virus, a drug-application milestone, a vaccine EUA, and more.
The pharma firm reports its Veklury (remdesivir) led to a reduction in mortality rate among hospitalized patients in three analyses of real-world data.
Thanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.
The US agency’s latest actions and advice against the virus include information on test recalls, , approval and reauthorization of treatments, and more.
The virtual clinical development firm’s analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
The EMPHATHY clinical trial will enroll patients with COVID-19 to test the drug’s effectiveness in preventing worsening of symptoms and hospitalization.
Acting FDA commissioner Janet Woodcock explains how government, researchers, doctors and patients can contribute to improving the clinical research system.
