Ian Schofield
Executive Editor
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Latest From Ian Schofield
EU First-Half New Drug Approvals Rebound After Slump In 2023
The number of medicines containing a new active substance approved for pan-EU marketing in the first six months of 2024 rose to near-normal levels after an unusually sharp dip in the 2023 period. The approvals were again led by cancer drugs, with therapies for blood disorders a close second, while half of the approvals were treatments for rare diseases.
EMA Sticks With JN.1 Variant For COVID-19 Vaccines, Despite US FDA's Choice of KP.2
Targeting the JN.1 subvariant of the SARS-CoV-2 virus will facilitate timely vaccination campaigns in Europe to help reduce the burden of disease associated with COVID-19, according to the EU regulator.
Environmental Risk Assessments To Loom Larger In EU Drug Reviews
In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.
EU Pharma Reform, SPCs, Compulsory Licensing Among Parliament’s ‘Unfinished Business’
A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.
EU Commission Sets Out Plans For New Life Sciences Strategy
As well as planning action to improve the EU’s competitiveness in the life science sector, the European Commission has confirmed that it will propose new legislation to reduce the bloc’s reliance on overseas suppliers of medicines as a way of tackling drug shortages.
EMA And Commission Correct Altuvoct, Celldemic, Lytenava Active Substance Status Discrepancies
Lytenava, Outlook Therapeutics’ ophthalmic version of bevacizumab for wet AMD, has been given the INN bevacizumab gamma, but it is not a new active substance, the EU authorities have confirmed.