Tower Mains Weekly Newsletter
FDA updates its FDA COVID-19 response summary
On 23rd July 2021, the U.S. Food and Drug Administration (FDA) updated its COVID-19 response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights of its response efforts.
Spikevax COVID-19 vaccine approved for children aged 12 to 17 in EU
On 23rd July 2021, the European Medicines Agency’s human medicines committee (EMA’s CHMP) recommended granting an extension of indication for the Spikevax COVID-19 vaccine (previously Moderna) to include use in children aged 12 to 17 years. The use of the vaccine will be the same as in people aged 18 and above.
European Commission publishes summary record for 94th meeting of the Pharmaceutical Committee
On 23rd July 2021, the European Commission published the summary record for the 94th meeting of the Pharmaceutical Committee held on the 28th of May 2021. Discussions included: the need to uphold double-blind randomised clinical trials as the gold standard for evidence generation; the need to increase collaboration on data generation among regulatory agencies, HTA bodies, payers, medical professionals, patients, and industry; and use of early access schemes and expedited pathways.
MHRA Inspectorate: How to play your part in protecting the UK medicines supply chain
On 26th July 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate published a blog on how to play a part in protecting the UK medicines supply chain. It will also host a free webinar on the 13th of August, which will offer further information and guidance on protecting the security of the UK supply chain.
WHO Global Advisory Committee on Vaccine Safety releases statement on reports of GBS
On 26th July 2021, the COVID-19 subcommittee of the World Health Organisation (WHO) Global Advisory Committee on Vaccine Safety (GACVS) shared its conclusions and recommendations following virtual meetings to discuss rare reports of Guillain-Barré Syndrome (GBS) following vaccination with the Janssen and AstraZeneca COVID-19 vaccines.
MHRA warns against purchasing inaccurate infrared thermometers
On 27th July 2021, the MHRA warned the public and healthcare professionals to take care when purchasing infrared thermometers online following the increase of inaccurate infrared thermometers making their way into the UK market. The influx is believed to have been caused by increased demand for infrared thermometers due to the COVID-19 pandemic.
ICH Q13 draft guideline reaches Step 2 of the ICH process
On 27th July 2021, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced that the Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products has reached Step 2 of the ICH process and now enters the public consultation period.
European Commission issues documents from EU Directors for Pharmaceutical Policy & Pharmaceutical Committee meeting
On 28th July 2021, the European Commission released documents from the joint meeting EU Directors for Pharmaceutical Policy & Pharmaceutical Committee held on the 8th and 9th July 2021. These include the agenda, alongside the policy briefings on improving access to essential antibiotics and repurposing of medicines in oncology.
FDA approves first interchangeable biosimilar insulin product for treatment of diabetes
On 28th July 2021, the FDA approved Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin product, shown to improve glycemic control in adults and paediatric patients with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. It also released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.
Issue Number: WN00021