MHRA approves ‘safer’ medicine alternative for rare disease
A new drug has been approved in the UK as a safer alternative to corticosteroids to treat Duchenne muscular dystrophy (DMD).
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A new drug has been approved in the UK as a safer alternative to corticosteroids to treat Duchenne muscular dystrophy (DMD).
The first biosimilar to Stelara® is now approved in Europe, a biologic therapy with indications across gastroenterology, dermatology, and rheumatology.
TALZENNA® is the first PARP inhibitor approved in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC) in the EU.
Anne Dhulesia and Sean Dyson, Partners at L.E.K. Consulting, discuss the proposed revisions to EU pharma legislation and potential implications for biopharma companies operating in Europe.
Approval of fezolinetant gives patients in Europe a new nonhormonal treatment option to control hot flashes or night sweats associated with menopause.
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
The EC’s approval of the immuno-oncology treatment “will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU,” says principal investigator of the RUBY trial.
The EU-UK Specialised Committee on Participation in Union Programmes has adopted the political agreement on UK’s association to the Horizon Europe programme.
A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.
Following a milestone approval by the European Commission in July 2023, Vertex Pharmaceuticals has been granted a label expansion for its cystic fibrosis medicine KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) with ivacaftor.
A Phase III trial evaluating rucaparib demonstrated that it significantly improved progression-free survival in women with advanced ovarian cancer, regardless of their BRCA mutation status.
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.
Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
The European Commission has published its much-anticipated proposed revisions to the EU pharmaceutical legislation. While not as extensive as some had anticipated, with elements such as the supplementary protection certificate – the demise of which has been foretold for years – continuing albeit in a different form, Elisabethann Wright, Partner,…