Regulatory Index News: 09/08/2018

Welcome to your Regulatory Index News digest this Thursday. Take a look here for an Ambys and Takeda partnership, a lawsuit settlement and an ICER boost for psoriasis.

Ambys Medicines and Takeda Announce Partnership to Pioneer First-in-Class Therapies for the Treatment of Serious Liver Diseases

Takeda has joined Ambys at the outset to develop their vision to build a transformative approach to liver diseases. The two companies have entered into a $100 million partnership in support of the discovery and development of therapies for people with serious liver disease. Ambys claim to be pioneering the application of novel modalities, including cell and gene therapy and gain-of-function drug therapy, to meet the urgent need for treatments that restore liver function and prevent the progression to liver failure across multiple liver diseases that are untreatable or poorly treated today. Please click here to read more on this from a PharmaTimes article.

AstraZeneca agrees payment of $110 million to the state of Texas in settlement of lawsuits relating to the drugs Seroquel and Crestor

$5 billion was the sum initially sought by the state of Texas under the lawsuits claiming the company had falsely and misleadingly marketed the two drugs Seroquel and Crestor.  Ultimately a settlement of $90 million in relation to allegations that AstraZeneca encouraged unapproved uses of antipysychotic Seroquel and the smaller $20 million settlement covering the allegations it misrepresented the benefits of anti-cholesterol drug Crestor, illegally promising it for treating atherosclerosis, and making unsubstantiated claims regarding its efficacy and safety were agreed. Please click here to read more on this from a PharmaTimes article.


Tremfya for psoriasis receives a boost from an ICER update

The Institute for Clinical and Economic Review (ICER) has published an updated report on targeted immunomodulators for plaque psoriasis, with analysis of several new drugs that have entered the market. Newer targeted immunomodulators, such as recently approved IL-17 inhibitors and Johnson and Johnson's Tremfya (guselkumab) and AbbVie's experimental risankizumab, both IL-23 blockers, were found by ICER to offer a net benefit over TNF-alpha inhibitors. Please click here to read more on this from a BioPharmaDive article.





Lorna Osborn

Date Published

09th August 2018

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