Industry news

• First Batch of 300,000 Doses of “Sputnik V” Vaccine Delivered to Argentina

  28 December 2020 GMP News

  The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the delivery of the first batch of 300,000 doses of Sputnik V, the world’s first registered vaccine against coronavirus, to Argentina.

• About 85% of those Vaccinated with “Sputnik V” Have no Side Effects

  28 December 2020 GMP News

  Some 85% of those vaccinated with Russia’s Sputnik V COVID-19 vaccine do not have any side effects, head of the Gamaleya Research Center for Epidemiology and Microbiology Alexander Ginzburg said on Thursday.

• Belarus Becomes the First Foreign Country to Register the “Sputnik V” Vaccine

  24 December 2020 GMP News

  The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, announces that Sputnik V, the Russian vaccine against coronavirus, has been registered by the Ministry of Health of the Republic of Belarus. Thus Belarus has become the first foreign country to officially register thThe Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, announces that Sputnik V, the Russian vaccine against coronavirus, has been registered by the Ministry of Health of the Republic of Belarus. Thus Belarus has become the first foreign country to officially register the vaccine.e vaccine.

• FDA Issued Emergency Use Authorization for Second COVID-19 Vaccine

  24 December 2020 GMP News

  The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

• The Key Regulatory Developments of 2020 in Russia and EAEU

  23 December 2020 GMP News

  The new video briefly looks at the key regulatory developments of 2020 in the sphere of IP protection, pricing and state procurement, EAEU common market and other issues.

• Malaysia plans to get Russia’s Sputnik V vaccine

  23 December 2020 GMP News

  Malaysia’s authorities signed a deal on purchasing 6.4 mln doses of a coronavirus vaccine produced by British-Swedish pharmaceutical company AstraZeneca and also expect Russia’s Sputnik V, Prime Minister Muhyiddin Yassin said in his televised speech on Tuesday (22 December).

• Production of Russian “Sputnik V” Vaccine against Coronavirus Launched in Kazakhstan

  22 December 2020 GMP News

  The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announce the launch of production of Sputnik V, the world’s first registered vaccine against coronavirus, – in Kazakhstan.

• EMA Recommends First COVID-19 Vaccine for Authorisation in the EU

  22 December 2020 GMP News

  EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.

• Russia, Germany to Hold Talks on Joint Production of Russian COVID-19 Vaccines

  21 December 2020 GMP News

  Russia and Germany will soon hold talks on possible joint production of Russian anti-coronavirus vaccines, the press service of the Russian health ministry said on Friday after Minister Mikhail Murashko’s telephone conversation with his German counterpart, Jens Spahn.

• FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

  21 December 2020 GMP News

  The U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. The FDA granted approval of Orgovyx to Myovant Sciences.