International
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
Postmarket optimization studies for cancer drugs can strengthen clinical trust in cancer medicines, which in turn results in therapies being used more often, a researcher says.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Incentives are “probably the only solution” to encouraging companies to optimize cancer drugs, but this will require funding and systemic changes, the chair of the European Medicines Agency’s oncology working party says.
New Zealand is also lifting its prohibition on advertising unapproved medicines at medical conferences and trade shows in order to boost its appeal as a host for such events and generate millions of dollars in revenue.
‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
Horizon scanning is a tool used by regulators to prepare for forthcoming medicines that might challenge existing processes. Senior figures from the European Medicines Agency, Swissmedic and the UK MHRA explain how they conduct horizon scanning activities in their respective jurisdictions.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Lawler, who leads the Therapeutic Goods Administration, has replaced the European Medicines Agency’s Emer Cooke as chair of the International Coalition of Medicines Regulatory Authorities.
Recipients of the public-private funding are also expected to receive wraparound support, including strategic guidance to identify the right progression pathway for their antimicrobial resistance asset and access to key resources and sector connections.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Making use of regulatory pathways such as fast-track designation, accelerated approval and conditional marketing approval can “really appeal to investors” and can help secure funding for clinical trials, says the CEO of rare disease biotech SynaptixBio Dan Williams.
Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.
The World Health Organization’s Global Clinical Trials Forum brings optimism for pharma companies and other stakeholders, as it aims to strengthen the clinical trials environment and infrastructure across nations.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The World Health Organization wants vaccine manufacturers and the scientific community to share certain types of data before its Technical Advisory Group on COVID-19 Vaccine Composition meets in December.
The European Commission, Parliament and Council should be mindful of ‘significant new risks’ posed by MFN drug pricing in the US during negotiations that will shape the bloc’s pharmaceutical legislation, a lawyer from Sidley Austin says.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.
A new guideline finalized by the International Council of Harmonisation is expected to reshape how non-interventional drug safety studies use real-world data, bringing clarity, consistency, and global alignment.