Tower Mains Weekly Newsletter
Company Updates
Tower Mains welcomes Erin Bell
We are delighted to welcome Erin Bell to the Tower Mains team. Erin joins us as Associate and will be responsible for organising and managing our internal quality management systems and our internal and external training programmes. She will be working on a programme of new courses that we will roll out during 2023. Read more…
Industry Updates
FDA revises letters of authorisation for Paxlovid and Lagevrio
On 2nd February, the US Food and Drug Administration (FDA) revised the letters of authorisation for two EUAs, Paxlovid and Lagevrio, to remove the requirement for positive test results to prescribe these products.
MHRA updates guidance on the phase I accreditation scheme
On 3rd February, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to join the phase I accreditation scheme. The agency updated the list of accredited units as of the 1st of February 2023.
HMPC re-elects Emiel van Galen as chair
On 3rd February, the European Medicine Agency (EMA) announced its Committee on Herbal Medicinal Products (HMPC) has re-elected Emiel Van Galen from the Botanicals and Novel Foods at the Medicines Evaluation Board (CBG-MEB) as its chair for another three-year mandate.
WHO reveals new roadmap on breast cancer
On 3rd February, the World Health Organisation (WHO) released a new Global Breast Cancer Initiative Framework providing a roadmap to attain the targets to save 2.5 million lives from breast cancer by 2040. The newly published framework leverages proven strategies to design country-specific, resource-appropriate, health systems for the delivery of breast-cancer care in low- and middle-income settings.
Public consultation to be launched on a multi-stakeholder platform to improve clinical trials in the EU
On 3rd February, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) announced they will be launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the EU. The platform is a deliverable of the joint initiative Accelerating Clinical Trials in the EU (ACT EU) and stakeholders are invited to send their comments on the platform concept paper, advise on the key priorities for discussion and express their interest to join the platform via an online form until 3rd of March 2023 at midnight CET.
EMA publishes closing report on action plan on the development of medicines for children
On 6th February, the EMA published the closing report of the EMA and European Commission (DG Health and Food Safety) action plan on paediatrics. The regulators have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children. Key improvements brought by the paediatric action plan include strengthening the focus on unmet medical needs, adapting regulatory processes to better support innovation and increased alignment of data requirements between decision-makers
ADVANZ Pharma enters into agreement with Alvotech to commercialise a proposed biosimilar to Xolair®
On 6th February, Advanz Pharma, a UK-based pharmaceutical company announced that it has entered into an exclusive agreement with Alvotech, a leading global biotech company specialising in the development and manufacture of biosimilar medicines, for the exclusive license and supply rights for a proposed biosimilar to Xolair®.
Forxiga approved in the EU for treatment of symptomatic chronic heart failure
On 7th February, AstraZeneca announced Forxiga has been approved in the EU to extend the indication for heart failure with reduced ejection fraction to cover patients across the full spectrum of left ventricular ejection fraction (LVEF). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) in December 2022 and was based on the positive results from the DELIVER Phase III trial.
MHRA releases official statistics on EAMS applications
On 8th February, the MHRA, published updated statistics on the applications pending, refused, and granted for the early access to medicines scheme (EAMS).
Issue Number: WN00098
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