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...
NICE says no to rival Alnylam and Akcea amyliodsis drugs – but deal could be done

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...
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...
FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

USA – FDA Finalizes Guidance on Post-CRL Meetings With ANDA Applicants

The US Food and Drug Administration (FDA) on Monday finalized guidance on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new...
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen...

Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who...

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