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Tau Interest Rising As Janssen Licenses AC Immune Alzheimer’s Vaccine

 
• By John Davis

AC Immune of Switzerland will work with Janssen on a therapeutic Tau-targeted vaccine for Alzheimer’s that is in Phase Ib and which could be used in combination with beta-amyloid based approaches to maximize therapeutic responses to the disease. J&J also has licensed a pioneering microbiome drug from Vedanta.

Abnormal forms of the neuronal Tau protein could play a role in several neuronal degenerative diseases and conditions, not only Alzheimer’s disease. The latest big pharma entering the field is Janssen R&D LLC (Johnson & Johnson), which has obtained a worldwide exclusive license to AC Immune’s potential anti-Tau therapeutic vaccine ACI-35 for Alzheimer’s disease and other taupathies.

ACI-35 is currently being evaluated in a Phase Ib study for Alzheimer’s disease, and Janssen plans to quickly advance the therapeutic vaccine into late-stage development

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.