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),...
Supply unlicensed medicinal products (specials)

UK – Supply unlicensed medicinal products (specials)

Details This Medicines and Healthcare products Regulatory Agency (MHRA) guidance is for those who want to manufacture, import, distribute or supply unlicensed medicines for human...
NICE issues guidance revision for depression

UK – Bayer’s Stivarga wins NICE backing for advanced liver cancer

Stivarga (regorafenib) is to be offered to advanced liver cancer patients in England and Wales whose liver is well-functioning but unable to be surgically...
Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines' Initial Release

Europe – Review and update of EMA guidelines to implement best practice with regard...

In February 2014, CHMP and CVMP published a joint concept paper announcing a review and update of EMA guidelines to implement best practice with...
BREXIT : où en est-on ?

UK – Industry Finds Fault With UK Vision for Drug Regulation After Brexit

British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The...
May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

Europe – Initiative citoyenne européenne: la Commission enregistre l’initiative «Let’s demand smarter vaping regulation!»

La Commission européenne a décidé aujourd'hui d'enregistrer une initiative citoyenne européenne intitulée «Let's demand smarter vaping regulation!». L'objectif de l'initiative est de: «créer une législation sur...
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – Completed Paediatric Studies – submission, processing and assessment in the event of...

The UK is leaving the EU on 29 March 2019. Securing a deal remains the Government’s top priority. This has not changed. However, the government must...
Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

USA – Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a...
NICE nod for Takeda’s Adcetris in advanced stage CTCL

UK – XLH patients to get routine access to first new therapy in 30...

The National Institute for Health and Care Excellence has published final guidance recommending use of Kyowa Kirin’s Crysvita (burosumab) within its marketing authorisation, that...
L’ancienne formule du Levothyrox sera bien disponible en 2019

France – L’ancienne formule du Levothyrox sera bien disponible en 2019

Les 42 patients qui ont assigné en justice, à Toulouse (Haute-Garonne), le laboratoire Merck ont été déboutés ce lundi. Ils ne recevront pas d’indemnités pour le...

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