Weekly News

Tower Mains Weekly Newsletter Company Updates WHO and MPP announce agreement with NIH for COVID-19 health technologies On 12th May, [...]

Tower Mains Weekly Newsletter Company Updates Tower Mains is delighted to welcome Olga Pavlovska as Senior Associate. Olga will be providing clinical [...]

Tower Mains Weekly Newsletter Industry Updates FDA approves first device indicated for the preservation of donation-after-circulatory-death hearts On 27th April, [...]

Tower Mains Weekly Newsletter Industry Updates FDA publishes guidance on the development of drug products including those that contain nanomaterials [...]

Tower Mains Weekly Newsletter Industry Updates FDA authorises first COVID-19 diagnostic test using breath samples On 14th April, the US [...]

Tower Mains Weekly Newsletter Industry Updates ECDC and EMA conclude it’s too early to consider using a fourth dose of [...]

Tower Mains Weekly Newsletter Industry Updates MHRA phase I accreditation scheme guidance updated  On 30th March, the Medicines and Healthcare [...]

Tower Mains Weekly Newsletter Industry Updates EMA recommends authorisation of Evusheld for treatment of COVID-19 On 24th March, the European [...]

Tower Mains Weekly Newsletter Industry Updates MHRA publishes video recording of the Medicines Supply for Northern Ireland webinar On 16th [...]

Tower Mains Weekly Newsletter Industry Updates The MHRA and other organisations across the UK unite to improve public involvement in [...]

Tower Mains Weekly Newsletter Industry Updates EMA’s PRIME scheme enables earlier availability of life-changing medicines On 3rd March, the European [...]

Tower Mains Weekly Newsletter Industry Updates MHRA updates guidance on clinical trials applications submitted for COVID-19 On 23rd February, the [...]

Tower Mains Weekly Newsletter Regulatory Updates Eudralex Volume 4 Annex 21 Importation of medicinal products published 16 February 2022 The [...]

Tower Mains Weekly Newsletter Industry Updates EMA issues meeting highlights from February PRAC meeting On 11th February, the European Medicines [...]

Tower Mains Weekly Newsletter Industry Updates MHRA approves Novavax COVID-19 vaccine Nuvaxovid On 3rd February, the Medicines and Healthcare products [...]

Tower Mains Weekly Newsletter Company Update Tower Mains is hiring! We are on the lookout for an Associate to further [...]

Tower Mains Weekly Newsletter Industry Updates FDA releases CDRH Health of Women Strategic Plan to better inform medical device research [...]

Tower Mains Weekly Newsletter Company Updates We have been published in this month’s issue of QUASAR, the Research Quality Association (RQA)'s [...]

Tower Mains welcomes Marina to the team Tower Mains is delighted to welcome back Marina Freiberga. Marina joined TMQA in [...]

Tower Mains Weekly Newsletter Company Updates Tower Mains is pleased to announce the following senior appointments: Rhona McAteer has been promoted [...]

Tower Mains Weekly Newsletter Industry Updates EMA launches the Regulatory Science Research Needs initiative ​​​​On 15th December, the European Medicines [...]

Tower Mains Weekly Newsletter Industry Updates FDA authorises new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 ​​​​On 8th December, [...]

Tower Mains Weekly Newsletter Industry Updates ICMRA holds high-level meeting on global health emergencies and regulatory approaches ​​​​ On 1st [...]

Tower Mains Weekly Newsletter Industry Updates EMA recommends approval for use of Comirnaty COVID-19 vaccine in children aged 5 to [...]

Tower Mains Weekly Newsletter Industry Updates FDA approves an abbreviated new drug application for vancomycin hydrochloride for injection ​​​​On 18th [...]

Tower Mains Weekly Newsletter Industry Updates EMA recommends authorisation of two monoclonal antibody medicines ​​​​On 11th November, the European Medicines [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Nicole LeBlanc as QA Associate. Nicole will be conducting audits [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to announce we are exhibiting at the virtual Research Quality Association [...]

Tower Mains Weekly Newsletter Industry Updates European Commission establishes portfolio of the ten most promising treatments for COVID-19 ​​​​On 22nd [...]

Tower Mains Weekly Newsletter Company Updates It’s our birthday! This month Tower Mains celebrates its 20-year anniversary, and we would [...]

Tower Mains Weekly Newsletter Industry Updates MHRA updates guidance on how it involves patients and the public in regulatory decision-making [...]

Tower Mains Weekly Newsletter Industry Updates EMA welcomes new Head of International Affairs ​​On 1st October 2021, the European Medicines [...]

Tower Mains Weekly Newsletter Industry Updates WHO recommends the use of Regeneron and Roche's COVID-19 antibody cocktail ​​On 24th September [...]

Tower Mains Weekly Newsletter Industry Updates FDA issues new Chapter 48 guidance for inspectorial programmes The U.S. Food and Drug [...]

Tower Mains Weekly Newsletter Industry Updates FDA revises guidance on the development of abbreviated new drug applications during the COVID-19 [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Judith O’Hagan to the Tower Mains team as Senior [...]

Tower Mains Weekly Newsletter Industry Updates MHRA updates its list of investigations and decisions carried out on advertising of medicines  On 27th August [...]

Tower Mains Weekly Newsletter Industry Updates FDA updates Pfizer-BioNTech COVID-19 vaccine EUA On 22nd August 2021, the U.S. Food and [...]

Tower Mains Weekly Newsletter Industry Updates  FDA authorises additional COVID-19 vaccine dose for certain immunocompromised individuals  On 12th August 2021, the U.S. Food and Drug Administration (FDA) amended the emergency [...]

Tower Mains Weekly Newsletter Company Updates We are delighted to welcome Naomi Ervine to the Tower Mains team as Senior [...]

Tower Mains Weekly Newsletter Industry Updates EMA announces increased manufacturing capacity and supply for Spikevax COVID-19 vaccine On 30th July [...]

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 It's International Clinical Trials Day and the Tower Mains team would like to show [...]

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 [...]