Industry news

• EMA Has Recommended New Gene Therapy to Treat SMA

  31 March 2020 GMP News

  EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.

• Russian Antitumor Drugs Received a Registration Certificate in Europe

  31 March 2020 GMP News

  Registration processes started in December 2018. During this time, a thorough examination of the drugs documentary and samples quality was carried out. According to the law, the first commercial series of the drug for sale is used for such an expertise. As a result, the Drug Agency decided to approve registration of two drugs: rituximab and trastuzumab.

• Russian Supercomputer Allow to Speed up Drug Development

  27 March 2020 GMP News

  Researchers working on means of COVID-19 coronavirus diagnostics and treatment have been granted priority access to the upgraded supercomputer of the Inter-Agency Supercomputer Center of Russian Academy of Science (RAS), RAS Krasnoyarsk Science Center said on its website.

• AI Finds Potential COVID-19 Drugs that Can Be Used on Humans Immediately

  27 March 2020 GMP News

  Gero, the leader in AI-driven drug discovery, has used its AI platform to identify the potential anti-COVID-19 agents that have been previously tested on humans. Six of them have been approved, three were withdrawn, and the other nine have been already tested in clinical trials. The emergency of the situation, as well as the legal and regulatory status of these agents, make it possible to start immediate clinical trials for most of the suggested drugs.

• WHO Recommend a Range of Innovative Approaches to TB Preventive Treatment

  26 March 2020 GMP News

  New World Health Organization (WHO) guidance will help countries accelerate efforts to stop people with tuberculosis (TB) infection becoming sick with TB by giving them preventive treatment.

• Data Requirements for Phase 1 COVID-19 Vaccine Trials

  26 March 2020 GMP News

  Global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

• The FDA Will Approve Biosimilars via a New Regulatory Pathway

  25 March 2020 GMP News

  Today (March 23, 2020) is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients.

• EC Has Announced €80 Million of Support to CureVac for COVID-19 Vaccine Development

  25 March 2020 GMP News

  The European Commission (EC) has offered €80 million of financial support to CureVac, a German biopharmaceutical company and vaccine developer, to aid in the scale-up of R&D and production of a vaccine against the novel COVID-19 coronavirus. The funding is provided as a European Investment Bank (EIB) loan.

• New Guidance: Clinical Trials During the COVID-19 Pandemic

  24 March 2020 GMP News

  The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials.

• Russian Specialists Sequenced the First Full COVID-19 genome

  24 March 2020 GMP News

  Russian scientists from the Smorodintsev Research Institute of Influenza have managed to decode the first full genome of the novel coronavirus (COVID-19), the Russian Health Ministry informed.