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Pint Pharma International S.A.

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Latest From Pint Pharma International S.A.

FDA Finalizes De Novo Process, Updates Related Guidance Docs

The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.

Regulation Review Pathway

Market Intel: Robotic Surgery Holds Great Promise, But Is Not Quite There Yet

In this final part of a three-part series on the “Future of Surgery” we highlight perspectives of a highly skilled orthopedic robotic surgeon on where we are today in robotic surgery and where we are going, introduce innovative surgical robotics companies, and discuss medtechs’ rising role in robotic surgery.

Market Intelligence Robotic Surgery

Deal Watch: AstraZeneca Continues Divestments By Offloading US/Canada Seroquel Rights

Pharma sells the rights to Germany’s Cheplapharm, which obtained EU/Russia rights in October. Cerecor will acquire Aevi Genomics for $16.1m plus contingent value rights.

Deals Business Strategies

Puma's Neratinib Gets CHMP Turnaround But Slow EU Uptake Expected

Puma Biotech has proven to be the cat with nine lives after its HER2+ breast cancer treatment neratinib received a u-turn from CHMP, granting it a positive trend vote. But even if final marketing approval is granted this year, European prospects don’t necessarily follow.

Cancer Europe
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