Tower Mains Weekly Newsletter
We are delighted to welcome Judith O’Hagan to the Tower Mains team as Senior Associate. Judith joins us with over 20 years of experience in clinical research and will be conducting audits and supporting clients in the area of GCP.
FDA reaches milestone in competitive generic therapy drug approvals
The U.S. Food and Drug Administration (FDA) announced it has reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation. This achievement highlights the success of the Competitive Generic Therapy program, which was designed to encourage the development and marketing of generic drugs for products with little to no competition. Additionally, more than 80% of the first-approved applicants who were eligible for Competitive Generic Therapy exclusivity started marketing the drug within 75 days after FDA approval.
Moderna announces submission for a CMA with the EMA for the evaluation of a booster dose of its COVID-19 vaccine
On 3rd September 2021, Moderna, Inc. announced it had submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of its COVID-19 vaccine at the 50µg dose level. The company stated that the amended Phase 2 study and additional analyses show that a 50µg booster dose of its COVID-19 vaccine induces robust antibody responses against the Delta variant. An additional analysis showed that a booster dose of mRNA-1273 at the 50µg dose level induced robust antibody responses and significantly increased geometric mean titers (GMT) for all variants of concern.
EMA issues highlights from latest PRAC meeting
On 3rd September 2021, the EMA issued highlights from its Pharmacovigilance Risk Assessment Committee meeting held on 30th August until 2nd September 2021. Highlights include the close safety monitoring of COVID-19 vaccines; important safety information for Imbruvica; and the extension of the mandate of vice-chair Martin Huber for another three years.
EMA evaluating data on booster dose of Comirnaty COVID-19 vaccine
On 6th September 2021, the EMA announced it had started evaluating an application for the use of a booster dose of the Comirnaty COVID-19 vaccine to be given six months after the second dose in people aged 16 years and older. The EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately six months after the second dose.
European Commission publishes summary record for the EU Directors for Pharmaceutical Policy & Pharmaceutical Committee meeting
On 7th September 2021, the European Commission published the summary record for the EU Directors for Pharmaceutical Policy & Pharmaceutical Committee meeting held on the 8th and 9th of July 2021.
MHRA updates guidance on accessing Electronic Health Records
On 8th September 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for Sponsors, Contract Research Organisations (CROs), and investigator sites when accessing Electronic Health Records (EHRs) in clinical trials. The information on viewing EHRs remotely was updated.
INCB, UNODC and WHO issue joint statement on access to controlled medicines in emergencies
On 8th September 2021, the International Narcotics Control Board (INCB), the United Nations Office on Drugs and Crime (UNODC), and the World Health Organisation (WHO) called on governments to facilitate access to medicines containing controlled substances in emergency settings, including during pandemics and the increasing number of climate-related disasters.
MHRA updates guidance on managing clinical trials during COVID-19 pandemic
On 8th September 2021, the MHRA updated its guidance on how investigators and sponsors should manage clinical trials during COVID-19. The information on remote monitoring for trials was updated.
MHRA updates information for healthcare professionals and the public about the Pfizer/BioNTech vaccine
On 9th September 2021, the MHRA updated the information for healthcare professionals and information for the public on the Pfizer/BioNTech COVID-19 vaccine to include information about receiving a third dose. It also updated the Regulation 174 Conditions document with an additional pharmacovigilance condition.
MHRA issues statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
On 9th September 2021, the MHRA confirmed that the Pfizer and AstraZeneca COVID-19 vaccines can be used as safe and effective booster doses and announced that the Joint Committee on Vaccination and Immunisation (JCVI) will advise on whether booster jabs will be given and if so, which vaccines should be used.
Issue Number: WN00027