The EU finally reached agreement on an update of the 20-year-old pharmaceutical legislation, more than five years after the EU Commission first put forward the case for reform and following two and a half years of negotiations on the new rules.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder.
Disco Pharmaceuticals GmbH announced the final close of its seed round at €36 million (US$42 million), as it shapes up novel targets it has discovered with its surfaceome platform technology for formal preclinical development.
Disco Pharmaceuticals GmbH announced the final close of its seed round at €36 million (US$42 million), as it shapes up novel targets it has discovered with its surfaceome platform technology for formal preclinical development.
Epilepsygtx Ltd. has raised a $33 million series A to fund a phase I/IIa trial of EPY-201, a gene therapy for treating drug-resistant focal epilepsy. EPY-201 uses an adeno-associated viral vector to deliver KCNA1, the gene encoding Kv1.1, a potassium ion channel that modulates neuronal excitability.
The U.K. government has announced it will cut the rebate pharma companies have to pay on net sales of new drugs, reducing the rate from the record of 22.5% in 2025 to 14.5% for 2026. That is less than the 15% cap agreed earlier this month as part of a U.K./U.S. economic prosperity deal, which placed a requirement on the U.K. to improve the operating environment for pharmaceutical companies.
The UK Health Security Agency (UKHSA) has identified a new recombinant strain of mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia. In a paper describing the new strain, the researchers at UKHSA say it is not possible to determine from a single genome how long the recombinant virus has been in circulation, or whether it will have a fitness benefit over currently circulating lineages.
The UK Health Security Agency has identified a new recombinant strain of mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia.
Ireland is taking stock of the implications Trump administration tariffs and drug pricing policies hold for its world-leading biomanufacturing sector, which has been largely built on the back of investment by U.S. pharma companies – and is hugely reliant on exports to the U.S.
