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Roche Digs In To Early Breast Cancer With New Perjeta Approvals

 
• By Emily Hayes

Better than expected FDA labeling for rising star Perjeta in neoadjuvant (before surgery) and adjuvant (after surgery) breast cancer could boost sales greatly beyond expectations, some analysts say.

HER2
Roche's HER2 franchise got a boost with new early breast cancer approvals for Perjeta. Above, immunohistochemistry for HER2 shows positive cell membrane staining in infiltrating ductal carcinoma.

Genentech Inc./Roche has strengthened its foothold in early breast cancer with a new supplementary US FDA approval for the rising HER2 franchise star Perjeta covering use in the adjuvant (after surgery) setting and full approval in the neoadjuvant (before surgery) line of therapy.

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Pipeline Watch: Eight Approvals And Three Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Leqembi Launch Set For Germany And Austria As EU Approval Finally Comes

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

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Europe Pharma Heavyweights Call For Higher Drug Prices At Home

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.

Galapagos Chief Exec Stoffels Leaving, While Firm Names Spinout’s CEO

 
• By Mandy Jackson

Paul Stoffels, the J&J research veteran who helmed Galapagos during a crucial period, will retire upon the appointment of a new CEO as the company continues its latest transformation.

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By Joseph Haas

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.