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Otsuka Pharmaceutical Co. Ltd.

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Latest From Otsuka Pharmaceutical Co. Ltd.

EMA Backs EU Approval For Ztalmy & Pylclari; Roches Withdraws EU Filing For AMD Implant

Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.

Europe Approvals

Pear Bankruptcy Filing Highlights Difficult Challenges Facing Digital Therapeutics

Pear Therapeutics filed for Chapter 11 bankruptcy in April and sold its remaining assets in an auction for about $6m. The demise of one the pioneers in the prescription digital therapeutics industry highlights the challenges PDT developers face getting their products reimbursed.

Digital Health Business Strategies

Otsuka/Lundbeck’s Rexulti Has Time To Build A Lead In The Alzheimer’s Agitation Market

The US FDA approved Rexulti as the first drug for agitation in Alzheimer’s disease, a multibillion-dollar market where Lundbeck estimates it could bring in $1bn in annual sales.

Approvals Business Strategies

Keeping Track: Showers Of Approvals In US FDA’s May Forecast

Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.

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