Tower Mains Weekly Newsletter

Industry Updates

MHRA approves one-dose Janssen COVID-19 vaccine

On 28th May 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) announced it had approved the one-dose Janssen COVID-19 vaccine. The vaccine has been approved after meeting the required safety, quality, and effectiveness standards, and is the first vaccine to be approved for protection against COVID-19 with a single dose.

Click to view source

MHRA update its guidance on COVID-19

On 28th May 2021, the MHRA updated its guidance on COVID-19. The update includes links to decision documents and press release on the approval of the COVID-19 Vaccine Janssen.

Click to view source

EMA and EUnetHTA issue report on their achievements since 2017

On 1st June 2021, the European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) issued a report on their achievements since 2017. By working together, EMA and EUnetHTA were able to help medicine developers enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies (HTAs). Furthermore, they encouraged new ways to generate evidence to address both regulatory and HTA information needs.

Click to view source             View report 

EMA recommends approval of additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine

On 1st June 2021, the EMA announced it had recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium. The recommendation by the Agency’s Committee for Human Medicines (CHMP) is expected to have a significant and immediate impact on the supply of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, in the European Union.

Click to view source

NRx Pharmaceuticals seeks FDA EUA for Covid-19 therapy Zyesami

On 1st June 2021, it was announced that NRx Pharmaceuticals had submitted an application to the FDA seeking Emergency Use Authorisation (EUA) for Zyesami (Aviptadil-acetate), for the treatment of critically ill Covid-19 patients with respiratory failure. In a multi-centre, randomised, placebo-controlled trial, subjects who received intravenous Zyesami showed increased chances of survival and freedom from respiratory failure at 60 days versus placebo. The clinical study report submitted to the FDA further registers statistically significant benefits for Zyesami on all key secondary endpoints.

Click to NRx announcement                Click to view source

FDA warns against using Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit

On 1st June 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication to warn the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) due to serious concerns about the performance of the tests and likely a high risk of false results when using these tests. Neither test has been authorised, cleared, or approved by FDA for distribution and use in the United States.

Click to view source

Moderna announces agreement with Thermo Fisher Scientific for manufacturing of Moderna’s COVID-19 Vaccine

On 1st June 2021, Moderna, Inc. announced that it had entered into an agreement with Thermo Fisher Scientific for fill/finish sterile manufacturing services and supply packaging for Moderna’s COVID-19 vaccine. Production will begin in the third quarter of 2021.

Click to view source

Issue Number: WN00013

Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@towermains.com with the subject “Weekly Newsletter Please”.