Regulatory Index News: 07/09/2018

Welcome to your Regulatory Index News digest for today, which features a multi-million dollar cash deal between Sandoz and Aurobindo, early enrollment completion of a Phase III trial in thyroid eye disease, and a FDA knock-back on Sunovion Pharmaceutical's ADHD drug

Aurobindo Pharma acquires dermatology business from Sandoz in $900 million deal 

Novartis is selling parts of its Sandoz generics business to Aurobindo for at least $900 million. The acquisition will add approximately 300 products, projects in development and commercial and manufacturing capabilities in the US for Aurobindo. The deal is expected to close sometime in 2019 and will support Sandoz’s strategic focus on complex generics, value-added medicines and biosimilars. Please click here to read more on this from a PharmaTimes article.


Enrollment in Thyroid Eye Disease trial completed early by Horizon

Thyroid Eye Disease (TED) is a rare autoimmune disease leading to local inflammation, orbital fibroblast proliferation and tissue expansion, which can lead to proptosis, or bulging of the eye. Horizon Pharma is conducting a confirmatory Phase III trial of teprotumumab in patients living with moderate-to-severe active TED and confirms it has completed enrollment ahead of schedule. Eighty three (83) patients at 13 sites across the US, Germany and Italy were enrolled in the study, and will receive either eight infusions of teprotumumab or placebo every three weeks for 21 weeks. Topline results are expected in 2nd quarter 2019. Please click here to read more on this from a PharmaTimes article.


Knock-back received by Sunovion for their Attention-Deficit Hyperactivity Disorder drug dasotraline

Sunovion Pharmaceuticals' short-term hopes for their attention-deficit hyperactivity disorder (ADHD) drug dasotraline have been sruck a blow by the issuance of a Complete Response Letter (CRL) by the US Food and Drug Administration (FDA). Further clinical data was requested in the CRL to evaluate the drug's efficacy and tolerability in ADHD. In the US there are around 11% of children between 4 and 17 years diagnosed with ADHD, with up to 60% of these expected to carry symptoms on into adulthood. Sunovion is planning to meet with the FDA to discuss its next steps. Please click here to read more on this from a BioPharmaDive article.










Lorna Osborn

Date Published

07th September 2018

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