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Novartis Thinks It Can Do Better With GSK’s Oncologics Than GSK Did

 
• By John Davis

Novartis stresses the blockbuster potential, in its hands, of three products – Votrient, Tafinlar and Mekinist – that it is acquiring from GSK as part of its narrowed focus on innovative pharmaceuticals, eye care and generics, and the divestment of vaccines, OTCs and animal health.

The acquisition of GlaxoSmithKline PLC’s portfolio of marketed oncology products by Novartis AG for $16 billion might be considered on the high side for half a dozen products with total sales of around $1.6 billion. But the Swiss company believes three of the products could be blockbusters in its hands, emphasizing the advantages of having a longstanding marketing focus on cancer drugs.

The purchase was part of a series of transactions announced April 22 that will see Novartis divesting its vaccines business...

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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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Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.