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EMA

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.

Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

EMA Greenlights Give Eylea And Stelara Biosimilars Momentum Across Europe

The EMA’s Committee for Medicinal Products for Human Use has issued positive opinions for multiple aflibercept and ustekinumab biosimilars, intensifying competition for Eylea and Stelara respectively in Europe. Meanwhile, a Biocon subsidiary also received a nod for a Neulasta biosimilar.

Santen Sees Potential In Myopia Market After Ryjunea Approval

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

End Is Nigh For 4SC After EMA’s No For Kinselby

The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.

Few Takers For EMA’s OPEN Pathway Prompts Rethink

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

EMA Explores Using AI Language Models To Refine Oncology Guidance

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.