Europe

The European Commission’s proposals to overhaul the EU pharma legislation, which will see some orphan drug incentives cut, would cause a “significant dip in innovation,” according to number crunching from pharma industry association EFPIA.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.

Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”

Quviviq is to become the first dual orexin receptor antagonist available on the National Health Service. Just over 20,000 people in England could receive treatment with the drug in its first year, says the health technology assessment institute, NICE.

Governments should increase financial resources for novel antimicrobial drug candidates in the later stages of development and tackle shortages of existing, underused antibiotics to combat antimicrobial resistance, says a new report from the OECD.

The European Medicines Agency is consulting on major changes to its decade-old guidance on the development of medicinal products for acute and long-term treatment of major depressive disorder.

The UK medicines regulator says the loss of experienced staff and the need to recruit and train new assessors resulted in temporary delays to clinical trial applications, but the crisis measures it put in place to address the situation mean it has now turned the corner.

A new database being set up in Switzerland is expected to improve the exchange of GMP and GDP information between the regulatory authorities and pharmaceutical companies and offer free access to electronic certificates.

The European Medicines Agency is to recommend whether the marketing authorization for Currax’s weight management drug should be maintained, varied, suspended or revoked.

The late delivery of the “pharmaceutical package” leaves little time for the legislative process to take shape before European Parliament elections are held in June next year.

The European Medicines Agency has recommended new uses for 11 approved medicines, including an antibody drug conjugate for treating advanced non-small cell lung cancer.

The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs. 

Important updates to good manufacturing practice guidelines are likely to mean medicine shortages, warns a German pharmaceutical industry group.

The European Medicines Agency’s CHMP was set to adopt opinions on SK Bioscience’s COVID-19 vaccine and Mycovia/Gedeon’s Vivjoa for vulvovaginal candidiasis during its September meeting, but both marketing authorization filings were voluntarily withdrawn.

A comparison of EU approvals of medicines containing a new active substance in the first six months of 2021, 2022 and 2023 shows a sharp decline in the 2023 first-half numbers. Three of the products approved by the European Commission in the first six months of this year were for cancer, while two were for infectious diseases (including HIPRA’s COVID-19 vaccine Bimervax). Two products had orphan drug status.