Drugs news in brief

Published: 1-Nov-2002
Regulatory


The first update to the European Union's inventory of national policies and regulations promoting the availability of orphan drugs has been completed and published by the European Commission.

This new detailed inventory lists all incentives made available by the EU and its Member States to support research into orphan medicinal products (1).

The European Agency for the Evaluation of Medicinal Products (EMEA) has released guidance papers on the clinical development of medicinal products for the treatment of HIV infection (2) and the clinical investigation of medicinal products for the treatment of rheumatoid arthritis (3).

Israeli pharmaceutical company MediWound is expecting to enjoy 10 years of EU patent protection, having secured anticipated European marketing approval for its burn therapy, said chairman Dr Avri Havron.

Debrase is derived from pineapple plant enzymes and dissolves necrotic tissue without damaging healthy cells, without grafts and with less final scarring. Its approval would follow Phase II trials being conducted in American and European burn centres.

The World Health Organisation has released a first edition of a WHO Model Formulary, which - uniquely - gives comprehensive information on all 325 medicines contained in the WHO Model List of Essential Drugs, including data on use, dosage, adverse effects, contraindications and other health warnings (4).

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  4. NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK
  5. FDA makes groundbreaking decision to waive clinical efficiency studies for monoclonal antibody biosimilars The University of Illinois secured the first-ever FDA acceptance to waive clinical efficiency studies (CESs) for the biological drugs

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