The European Medicines Agency (EMA) has issued a reminder that from 31 January 2023 clinical trial sponsors must use the Clinical Trials Information System (CTIS) for initial trial applications.
A deal valued at $27.8 billion has been struck between Amgen and Horizon Therapeutics, wherein Amgen will buy the orphan drug manufacturer.
In 2023 manufacturers of branded medicines will be required to return almost £3.3bn in sales revenue to the government under the 2019 Voluntary scheme for branded medicines, pricing and access (VPAS), according to the Association of the British Pharmaceutical Industry (ABPI).
What is the outlook for medical affairs up to 2030, and what are the advantages for pharma and biotechs from outsourcing this function to external specialists?
The Regulatory Affairs Professionals Society (RAPS) reports that the European Council supports a proposal made by the European Commission to delay the transitional deadlines for medical devices under the MDR.
Figures from the ‘Bioscience and health technology sector statistics 2021’, published on 1 December 2022, provide analysis of trends in the UK life sciences industry from 2009 to 2021.
Medical affairs is an increasingly complex discipline. It is vital that the team is highly trained and able to adapt to an evolving environment, liaising effectively with stakeholders to communicate value and bring new treatments to the market. Read on to discover some of the challenges and trends affecting the sector.
A report commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA) has led the organisation to warn that the options being discussed by policymakers around the EU Pharma Strategy fall short.
Pharmacovigilance (PV) – the proactive maintenance of drug safety through collection, detection, assessment, monitoring and prevention of adverse effects – has been evolving since the first concerns were raised over the negative effects of chloroform anaesthetic in the 1800s. Today, it is just as important that pharma, start-ups and regulators keep up to date with the latest trends to ensure that drugs are safe and monitoring practices remain fit for purpose.
The Biotechnology Innovation Organisation (BIO), Developing Countries Vaccine Manufacturers’ Network (DCVMN) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) met at the ‘Global Equity & Timely Access: COVID-19 and Beyond’ meeting in India in October and announced their support for the Berlin Declaration ‘biopharmaceutical industry vision for equitable access in pandemics’.
