High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin

Europe – High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin

Roche/Genetech’s anti-VEGF therapy Avastin (bevacizumab) is not licensed to treatment wet-AMD, but trials have shown that it is as safe and effective (IVAN trial),...
NICE u-turn on Opdivo for skin cancer recurrence

UK – NICE u-turn on Opdivo for skin cancer recurrence

The Institute rejected use of the drug in this setting earlier this year on grounds that it was not cost-effective enough, but has now...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – FDA touts record-breaking number of October generic approvals

In October, the Food and Drug Administration approved 110 generic drugs and tentatively approved 18 generic drugs for a total of 128 approval actions. The...
Takeda’s HAE drug Takhzyro backed by NICE

UK – Brineura hit with NICE rejection

Brineura (cerliponase alfa) is a treatment for neuronal ceroid lipofuscinosis type II (CLN2) - also known as Batten disease, which costs over £500,000 per...
Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

International – ICH Adds Four New Regulatory Observers

Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals...
Nitrosamines : Que doit-on faire ?

Europe – Nitrosamines : Que doit-on faire ?

Par mesure de précaution et à la demande de l’Agence européenne des médicaments (EMA) en accord avec les autres autorités européennes, tous les titulaires...

USA – Expert U.S. panel develops NIH treatment guidelines for COVID-19

A panel of U.S. physicians, statisticians, and other experts has developed treatment guidelines for coronavirus disease 2019 (COVID-19). These guidelines, intended for healthcare providers,...
WHO drafts guidance for pharma supply chain tracking

International – WHO takes stock of global COVID-19 R&D progress

Researchers, developers and funders from across the globe attended the two half-day virtual summit on 1 and 2 July to examine the progress made...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – EDQM releases updated European Pharmacopoeia vaccines package for COVID-19 vaccine developers

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines. Originally published in...

Europe – EMA initiatives for acceleration of development support and evaluation procedures for COVID-19...

The European Medicines Agency (EMA) together with the responsible scientific committees and their working parties, and in collaboration with the European Commission, operates rapid...

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