Industry news

• Optimize Scale-Up for Vaccine and Therapeutic Manufacturing

  30 November 2021 FierchBiotech

  To meet the urgent demand for SARS-CoV-2 vaccines and therapeutics in the shortest possible timeframe, many companies are designing their scale-up processes in parallel with Phase III clinical trials, redefining the risk tolerance for everyone involved. To satisfy commercial requirements for expedited scale-up, the molecule can no longer dictate the technology transfer process into the manufacturing facility.

• RDIF states when Sputnik V against the omicron strain will be available on the market

  30 November 2021 GxPnews

  Manufacturers of Sputnik V and Sputnik Lite vaccines against coronavirus will be able, if necessary, to supply hundreds of millions of doses of the vaccine adapted against the omicron strain to the markets by February 20, 2022, said Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF).

• Social media is transforming our understanding of drug safety

  29 November 2021 Daniel Ghinn / European Pharmaceutical Review

  Social media has transformed people’s lives. From Twitter to Tumblr, it is estimated that by 2025 more than half the world’s population (4.41 billion people) will use social media in some form. As engagement rises so too does the level of information shared. Advancements in our capacity to monitor and interpret this information is also improving.

• In Russia, 177 new stations will produce more than 350 tons of oxygen daily

  29 November 2021

  5.5 billion rubles was allocated from the budget for the purchase of 177 new oxygen stations. They will produce more than 350 tons of oxygen daily for 50 regions of Russia,  Rossiyskaya Gazeta writes.

• New Solution Helps Accelerate and Optimize Approval of Marketing Materials

  26 November 2021 Pharmaceutical Executive

  EY has announced the launch of EY Smart Reviewer, a technology-driven solution that leverages artificial intelligence (AI) and natural language processing to help accelerate and improve the process to review materials used to market pharmaceutical and medical device products.

• The EAEU has approved a plan of strategically important medicines supply until 2024

  26 November 2021 GxPnews

  The Eurasian Intergovernmental Council approved an action plan to increase the level of supply of the EAEU states with strategically important medicines and pharmaceutical substances for medical use, the production of which must be ensured in the EAEU by 2024. The corresponding order was published on the website of the Eurasian Economic Commission.

• FDA, working to tackle pandemic inspection backlog, struggles with foreign oversight and site visits for new drugs

  25 November 2021 Fraiser Kansteiner / FiercePharma

  More than a year and a half into the COVID-19 pandemic, the FDA has started to right the ship on the pace of its domestic drug manufacturing inspections. Still, the agency continues to struggle with oversight of foreign plants, and a growing number of new drug applications are facing delays, a report shows.

• The Circle of Kindness Foundation receives up to 70 new applications for medicines supply every week

  25 November 2021 GxPnews

  The Circle of Kindness Foundation for the support of children with life-threatening and chronic diseases receives about 50-70 applications from the regions for the provision of medicines every week. This was announced on Monday, November 22, by Aleksander Tkachenko,  the head of the Foundation, TASS reports.

• Mishustin called for ensuring equal availability of medicines in the EAEU

  24 November 2021 GxPnews

  According to Mikhail Mishustin, the Prime Minister of the Russian Federation, safe and effective medicines should be equally accessible to all citizens of the countries of the Eurasian Economic Union (EAEU).

• Russia will reinforce the control over the formation of prices for medicines from the list of VED

  23 November 2021 GxPnews

  Mikhail Mishustin, the Russian Prime Minister, has signed a decree on the procedure for state control over price markups for medicines that are included in the list of vital and essential drugs (VED). This was reported in the press service of the Government of the Russian Federation.