Industry news

• Minimizing Contamination During Biopharma R&D

  03 July 2020 David Phillips / BioPharm International

  The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

• Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

  03 July 2020 Jill Wechsler / BioPharm International

  The need for treatments to combat the spread of COVID-19 is promoting greater cooperation among drug regulatory authorities around the world. FDA officials are communicating more frequently with their counterparts in Europe, Canada, Japan, and other nations through established programs and agreements. In addition, the International Coalition of Medicines Regulatory Authorities (ICMRA) has expanded its program to facilitate regular discussions among some 30 governmental and international agencies. These efforts seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

• Russian Biotechnologists Have Created a Product for Intestinal Health

  02 July 2020 GMP News

  The NRU “BelSU” biotechnologists have created a probiotic seasoning mixture for improving intestinal microflora and preventing infectious diseases.

• Russian Vaccine Against Coronavirus does not Cause Serious Adverse Reactions

  02 July 2020 GMP News

  Experts at the Sechenov University have not observed any adverse side effects on volunteers injected with the domestically-made vaccine against the coronavirus. All the subjects are in good health, the main researcher, Yelena Smolyarchuk, who heads the Sechenov University Center for Expert Evaluation of Medicinal Products told TASS.

• In Russia Developed a New Feed Additives Production Technology

  30 June 2020 GMP News

  Biocomposite feed additive for farm animals and poultry, created as part of the REC “Innovative Solutions in the Agro-Industrial Complex”, neutralizes mycotoxins.

• WHO, global partners launch $18B COVID-19 vaccine initiative

  30 June 2020 Eric Sagonowsky / FirecePharma

  As wealthy countries race to secure supplies of potential COVID-19 vaccines, the World Health Organization (WHO) unveiled (PDF) an ambitious effort with global partners to provide billions of doses worldwide.

• Institute of Genetic Technologies to Open in Siberia

  29 June 2020 GMP News

  A unique centre specializing in innovative “genomic research and genetic technologies” is to open doors at Novosibirsk State University (NSU). The Institute of Genetic Technologies (IGT), cofounded by the Institute of Cytology and Genetics (Russian Academy of Sciences, Siberian Branch) and NSU, will deliver education and implement joint research projects. The new Institute is expected to start work this autumn.

• Russia Intends to Invest in the Production of Two more Drugs Based on Favipiravir

  29 June 2020

  The Russian Direct Investment Fund (RDIF) is considering the possibility of investing in several more Favipiravir-based drugs, Chief Executive Officer Kirill Dmitriev said on June 25.

• FDA Launches a Pilot Program to Inform Patient Reported Outcomes from Cancer Clinical Trials

  26 June 2020 GMP News

  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.

• The Second Group of Volunteers Vaccinated against Coronavirus in Moscow

  26 June 2020 GMP News

  “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.