Weekly News

Tower Mains Weekly Newsletter Industry Updates FDA updates its FDA COVID-19 response summary On 23rd July 2021, the U.S. Food [...]

Tower Mains Weekly Newsletter Company Updates  We are delighted to be able to offer bursary places on our next virtual [...]

Tower Mains Weekly Newsletter Industry Updates EMA publishes highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) meeting On 9th July [...]

Tower Mains Weekly Newsletter Industry Updates MHRA publishes new Delivery Plan centred on putting patients first On 4th July 2021, [...]

Tower Mains Weekly Newsletter Industry Updates FDA issues EUA for COVID-19 treatment On 24th June 2021, the U.S. Food and [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Robbie Boyle to the Tower Mains team as Senior QA Associate.   [...]

Tower Mains Weekly Newsletter Industry Updates FDA warns public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for [...]

Tower Mains Weekly Newsletter Industry Updates FDA posts update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page [...]

Tower Mains Weekly Newsletter Industry Updates MHRA approves one-dose Janssen COVID-19 vaccine On 28th May 2021, the Medicines and Healthcare [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Greta Čepanonyté to the Tower Mains team as QA [...]

Tower Mains Weekly Newsletter Company Updates Tower Mains will be hosting a webinar on the 18th of May on the [...]

Tower Mains Weekly Newsletter Company Updates On the 18th of May, Tower Mains will be hosting a webinar on the [...]

Tower Mains Weekly Newsletter Industry Updates EC approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for endometrial cancer The [...]

Tower Mains Weekly Newsletter Industry Updates New ISO Standard addresses Medical Device Labelling A new ISO Standard on Medical Device [...]

Company Updates We are delighted to announce that we will be offering an Introduction to ICH GCP (R2) Training Course [...]

Company Updates Over the past few weeks, we’ve been sharing our QMS plans, and insights, and it’s now time you [...]

Company Updates From 1st-10th April, our Senior Associate Maxim Bunimovich will be taking part in the 'New Clinical Stars' project, [...]

Company Updates We are delighted to announce that our Managing Director Andrew Waddell and Head of Quality Assurance Shona Ross, [...]

Company Updates We are delighted to announce that exciting Clinical and Quality Assurance opportunities have arisen within the Tower Mains [...]

Company Updates We are delighted to announce that Colin MacDonald PCQI, LRSC, APM will be joining the Tower Mains team [...]

Medicines and Healthcare products Regulatory Agency (MHRA) MHRA publishes GCP inspection metrics report On 15th February 2021, the MHRA published [...]

For your information this will be the last monthly issue of Pharma News. Going forward we will have weekly news [...]

Medicines and Healthcare products Regulatory Agency (MHRA) MHRA guidance on Phase I accreditation scheme On the 18th December 2020 (updated [...]

COVID-19 Vaccine Development Moderna COVID-19 Vaccine Has Neutralising Activity Against Emerging Virus Variants On 25th January 2021, Moderna, a biotechnology [...]

COVID-19 Vaccine Development Russia’s COVID-19 Vaccine Data Shows 91.4% Efficacy Rate On 14th December 2020, Russian coronavirus vaccine developers published [...]

Medicines and Healthcare products Regulatory Agency (MHRA) MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory [...]

COVID-19 Vaccine Development Oxford University and AstraZeneca’s AZD1222 Vaccine Meets Primary Efficacy Endpoint in Preventing COVID-19 On 23rd November 2020, [...]

COVID-19 Vaccine Development MHRA Initiates Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 On 27th October 2020, Moderna, a biotechnology [...]

Medicines and Healthcare products Regulatory Agency (MHRA) Updated guidance on Clinical Trial Applications for Coronavirus (COVID19) On 5th October 2020, [...]

COVID-19 Vaccine Development AstraZeneca Under Fire for COVID-19 Vaccine Safety, Releases Trial Protocol Following scrutiny over a potential patient side [...]

COVID-19 Vaccine Development EC Signs COVID-19 Vaccine Contract with AstraZeneca On 27th Aug 2020, the European Commission (EC) announced that [...]

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) Update on MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID-19) Guidance The update on [...]

On 31st July 2020 MHRA updated “Good clinical practice for clinical trials” on their website available here. Guidance for the [...]

COVID-19 Vaccine Development Dynavax and Medigen Announce Partnership for a Novel Adjuvanted COVID-19 Vaccine Candidate On 23rd July 2020, Dynavax [...]

Medicines and Healthcare products Regulatory Agency (MHRA) Updates on MHRA Regulatory Flexibilities resulting from Coronavirus (COVID-19) guidelines The MHRA issued [...]

COVID-19 Updates Medicines and Healthcare products Regulatory Agency (MHRA) Dexamethasone - World first coronavirus treatment approved for NHS use by [...]

COVID-19 Vaccine Development Oxford University’s COVID-19 Vaccine Boosts Immune Response in Pigs On 23rd June 2020, the Pirbright Institute in [...]

Medicines and Healthcare products Regulatory Agency (MHRA) MHRA issues a scientific opinion for the first medicine to treat COVID-19 in [...]

COVID-19 Vaccine Development Moderna Announces Positive Interim Data of COVID-19 mRNA Vaccine On 18th May 2020, Moderna Inc., a clinical [...]

COVID-19 Vaccine Development Sanofi and GlaxoSmithKline (GSK) Collaborate in Adjuvanted Vaccine for Coronavirus (COVID-19)  On 14th April 2020, Sanofi and GSK announced that they have signed [...]

BEFORE THE AUDIT  Decide on the audit scope  Check whether there are resources at the site or Clinical Research Organisation (CRO) (if the on-site [...]

COVID-19 Vaccine Development National Institutes of Health (NIH) Initiates Clinical Trial of Investigational Vaccine for COVID-19 On 16th March 2020, [...]

Guidance Documents on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic Released in March European Medicines Agency (EMA), [...]

LABORATORIES New documents or drafts for comment  There are no new Organisation for Economic Co-operation and Development (OECD) documents or drafts released for [...]

GSK and CEPI Joint Collaboration for Development of Coronavirus Vaccine On 3rd February 2020, the Coalition for Epidemic Preparedness Innovations [...]

EMA Management Board: Highlights of December 2019 Meeting The European Medicines Agency (EMA) released a summary of the December Management [...]

Nobel Prize-winner Frances Arnold retracts paper, saying results were not 'reproducible' On 2nd January 2020, Frances Arnold, an American scientist [...]

BEFORE THE AUDIT Ensure that there is a robust CDA in place. This may be covered by the CDA between [...]