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EU Crunch Time For Mirikizumab, New Covid-19 Vaccine & Other Drugs
The European Medicines Agency’s human medicines committee, the CHMP, is this week deciding whether to back marketing approval for eight new drugs and a coronavirus vaccine.
European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation
The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.
EMA Report Highlights Parallel Regulatory/HTA Consultations Among Achievements
A report from the EMA summarizing the mid-term achievements of its Regulatory Science Strategy to 2025 covers health technology assessments and a range of other topics.
EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.
EU Guide Outlines Important Considerations For Submitting Complex Trials In CTIS
EU regulators have issued a new Q&A document on the key aspects that sponsors of complex trials should consider when making new submissions or moving ongoing studies to the Clinical Trials Information System.
EU Commission Again Delays Pharma Revision Proposals, Citing ‘Busy Agenda’
Two members of the European Parliament claim the latest delay to publication of the long-awaited legislative revision is the result of pressure from the pharmaceutical industry.
Upstaza: First Gene Therapy For Ultra-Rare Disorder AADC Deficiency Receives English Funding
The single-dose gene therapy for aromatic L-amino acid decarboxylase in children is to be made available on the National Health Service following a confidential commercial deal between NHS England and PTC Therapeutics.
UK’s Revamped Clinical Trials Framework To Offer Faster Application Review Timelines Than EU
The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.
Mixed Support For ABPI's UK Price Scheme Proposals
The UK pharma industry body has set out bold proposals for a new drug pricing agreement from 2024, but not everyone is convinced. Generics companies are pressing for more of a say in the negotiations, while patient groups want to know more about how the deal would help improve access to medicines.
Rare Disease Body Wants EU Legislative Overhaul To Address Orphan Definitions & Incentives
Eurordis has welcomed some parts of the leaked proposals for overhauling the EU medicines legislation, but it has a number of concerns, including the future role of patient representatives if the European Medicines Agency’s committee structure is slimmed down as planned.
‘Gene Silencing’ Drug Oxlumo Wins English Funding After Alnylam Improves Discount
Health technology assessment institute NICE has reversed its provisional rejection of Oxlumo for treating the rare disease, primary hyperoxaluria type 1.
New EU Filings
Sugemalimab, from CStone Pharmaceuticals/EQRx, for use in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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