Industry news
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FDA Launches a Pilot Program to Inform Patient Reported Outcomes from Cancer Clinical Trials
26 June 2020
The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labeling and, therefore, is largely inaccessible to the public.
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The Second Group of Volunteers Vaccinated against Coronavirus in Moscow
26 June 2020
“The clinical trials of a vaccine against COVID-19 continue at the Sechenov University of the Russian Ministry of Health. On June 23, 2020, the second group of 20 volunteers received an injection of the sample at the Practical Research Center for Interventional Cardiovasology which is part of the University Clinical Center,” the statement said of the Sechenov First Moscow State Medical University.
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Sergey Tsyb: The Number of API Manufacturers in Russia Has Grown by 80% in Five Years
25 June 2020
The number of production sites manufacturing pharmaceutical substances in Russia has reached 95, having increased by almost 80% between 2015 and 2019, First Deputy Minister of Industry and Trade Sergey Tsyb shared during the conference “Pharmaceutical Industry in 2020” on June 17.
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25 June 2020
Launching a new drug is an arduous task even in the best of times. Drugmakers build their commercial teams from scratch, spending months of effort and huge sums of money to ensure their med reaches as many physicians, patients and payers as possible.
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The Pharma Trends you Need to Know—A CDMO’s Perspective
23 June 2020
The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development.
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How—and when—can the coronavirus vaccine become a reality?
23 June 2020
It’s been six months since researchers in China said they had identified (PDF) a novel coronavirus spreading in the city of Wuhan. Hope and desire for a vaccine to end the global devastation is growing with each passing week.
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Eighteen Volunteers Vaccinated against Coronavirus in Russia
22 June 2020
Sechenov First Moscow State Medical University (Sechenov University) has launched clinical trials of a vaccine against coronavirus. Eighteen volunteers have been vaccinated, Director of the university’s Institute for Translational Medicine and Biotechnology, Vadim Tarasov, said on June 18.
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Sergey Tsyb: The Number of API Manufacturers in Russia Has Grown by 80% in Five Years
22 June 2020
The number of production sites manufacturing pharmaceutical substances in Russia has reached 95, having increased by almost 80% between 2015 and 2019, First Deputy Minister of Industry and Trade Sergey Tsyb shared during the conference “Pharmaceutical Industry in 2020” on June 17.
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Clinical Trials of Russian Vaccine against Coronavirus Began
19 June 2020
The study of two forms of a COVID-19 vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology started on Wednesday in Russia. Two groups of 38 volunteers each are participating in the trials, the press service of the Russian Ministry of Health reported.
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FDA Publishes Guidance on Impact of COVID-19 on Clinical Trials
19 June 2020
FDA published guidance on June 16, 2020 on statistical considerations regarding the potential impact of COVID-19 on clinical trials that are conducted during the pandemic. Impacts may include the inability of trial participants to visit clinical sites for endpoint assessments. In the guidance, FDA outlines what should be considered when it comes to analysis of primary and key secondary endpoints in clinical trials impacted by COVID-19 “to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.”
