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Merck Enters The Alzheimer’s Disease Race, Plans Filings For Five New Drugs

 
• By Wendy Diller

As Merck heads into a “patent cliff” year, highlights of its analyst meeting included updates on key Phase III drugs, growth in emerging markets, and unveiling of new programs in Alzheimer’s disease and diabetes.

Merck & Co. Inc.’s R&D day Nov. 10 started with a gift to investors – a long-delayed dividend hike of 10.5% – and a pitch by CEO and president Kenneth Frazier to focus on the company’s long-term commitment to innovation as a path to creating shareholder value.

The company is balancing its short- and long-term prospects, as it faces the patent expiration next August of one of its key drugs, Singulair (montelukast) for allergies and asthma, said Frazier

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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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Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.