Industry news

• Registration for the COVID-19 Vaccination in Russia Will Open on December 4

  04 December 2020 GMP News

  Registration for inoculation against the coronavirus in Moscow will open on the websites of the Mayor and the Moscow government on December 4; doctors, teachers, and social workers will be the first to get inoculated. Vaccination stations will open on December 5, Moscow Mayor Sergei Sobyanin wrote in his blog on Thursday (3 December).

• Russia May Start Production of COVID-19 Vaccines in States CSTO

  04 December 2020 GMP News

  Russian President Vladimir Putin has said that the issue of supplying Russian coronavirus vaccines to the member-states of the Collective Security Treaty Organization (CSTO) and their joint production is being explored.

• UK Authorises Pfizer-BioNTech COVID-19 Vaccine

  03 December 2020 GMP News

  Pfizer Inc. and BioNTech SE announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic.

• Who's your pick for the next FDA chief? Nominate now, start voting next week

  03 December 2020 Beth Snyder Bulik / FiercePharma

  Before President-elect Biden announces his own choice for the FDA top spot, Fierce Pharma wants to know what readers think. Who do you think is the best man or woman to serve as the nation’s next top drug regulator?

• EMA Starts Rolling Review of Janssen’s COVID-19 Vaccine

  02 December 2020 GMP News

  EMA’s human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen Vaccines & Prevention B.V.

• Clinical Trials of the Russian “Sputnik V” Vaccine Have Begun in India

  02 December 2020 GMP News

  Dr. Reddy’s Laboratories Ltd., and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.

• Hand-held ultrasound developer Butterfly Network to go public through $1.5B acquisition deal

  30 November 2020 Conor Hale / FierceBiotech

  Hand-held ultrasound developer Butterfly Network is going public through a $1.5 billion acquisition deal backed by the hedge fund Glenview Capital Management.

• The Expert Spoke about Contraindications to Vaccination against Coronavirus

  27 November 2020 GMP News

  Asthmatics, diabetics and former cancer patients may have contraindications from a coronavirus vaccine, Head of the Department of General Virology of the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of the Russian Academy of Sciences Georgy Ignatyev said at a press conference at TASS.

• Cancer-killing virus escapes immune destruction and fights metastatic lung tumors in mice

  27 November 2020 Arlene Weintraub / FiercePharma

  Several viruses have a natural ability to kill cancer, but translating them into treatments has proven challenging, partly because the immune system tends to eradicate them before they can reach cancer cells. Researchers from Emory and Case Western Reserve say they’ve found a way to overcome that challenge with a specially engineered virus.

• The European Union is planning tough measures to boost its access to drugs

  26 November 2020 GMP News

  The European Commission has adopted a Pharmaceutical Strategy for Europe to ensure patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity and sustainability of the EU’s pharmaceutical industry. The Strategy will allow Europe to cover its pharmaceutical needs, including in times of crisis, through robust supply chains. The Strategy will help to establish a future-proof and crisis-resilient EU pharmaceutical system.