Reflection paper on regulatory requirements for the 5 development of medicinal products for chronic non6 infectious liver diseases (PBC, PSC, NASH)

Europe – EMA: More Staff Than Anticipated Quit Ahead of Brexit Relocation

The European Medicines Agency (EMA) says it will further scale back operations as staff who do not intend to relocate to Amsterdam next year...
The First FDA-approved Digital Pill - What It Means for Pharma

USA – The First FDA-approved Digital Pill – What It Means for Pharma

In mid-November 2017, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill...
Intracranial Hemorrhage Detection Software Receives FDA Clearance

International – Pfizer to increase some drug prices in 2019

Pfizer announced Friday it is raising the prices of dozens of drugs in 2019 after bowing to pressure earlier this year from President Donald Trump and...
Novartis first to benefit from NICE advice on ‘patient preference’

UK – NICE says no to rival Alnylam and Akcea amyliodsis drugs – but...

The draft highly specialised technologies guidance on Tegsedi (inotersen) and Onpattro (patisiran) concluded that both treatments slows progression of the disease and improve quality...
Les « Pharma Papers » : tout ce que les labos pharmaceutiques voudraient vous cacher

France – Les « Pharma Papers » : tout ce que les labos pharmaceutiques...

Les magazines BastaMag et l'Observatoire des multinationales, en partenariat avec le collectif EurosForDocs, viennent de lancer les « Pharma Papers » "pour mettre en lumière...
EU Advances SPC Waiver Proposal

Europe – EU Advances SPC Waiver Proposal

The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the...
Europe - Adjusted fees for applications to EMA from 1 April 2019 - Regulatory information

Europe – EMA Closes London Office, Preps for New Time Zone

After 24 years in London, the European Medicines Agency (EMA) on Friday has officially departed and is on its way to Amsterdam following a...
Thomas Dreyfuss

Emerging Market Access Strategy in the Pharmaceutical Industry the example of Thailand – by...

Thomas is PharmD and started his professionnal activity at WHITE-TILLET where he was trained in International Market Access analysis and process. After a MBA...
FDA Finalizes Testicular Toxicity Guidance

USA – FDA Finalizes Testicular Toxicity Guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on identifying and evaluating early signals that could indicate whether a...
How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?

International – How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?

Implantable technologies have come a long way over the years, and advancements in micro and nanotechnologies have helped device developers continue to push the...

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