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Sunovion Pharmaceuticals Inc.

Division of Sumitomo Chemical Co.
www.sunovion.com

Latest From Sunovion Pharmaceuticals Inc.

Lupin Awaits 'Clarity' On Albuterol Filing

After lower growth in its India business and impaired operations at five manufacturing units hit by US FDA action impacted Lupin's third-quarter revenues, one-offs sent its net profit crashing. While deferring reinspection timelines for its Goa and Somerset plants, the company remains confident of adding at least 15 products to its US portfolio in FY21.

Strategy Sales & Earnings

Lupin US Launches On Track But Albuterol 'Clarity' Awaited

After lower growth in India business and impaired operations at five manufacturing units hit by US FDA action impacted Lupin's third-quarter revenues, one-offs sent its net profit crashing. While deferring reinspection timelines for its Goa and Somerset plants, the company remains confident of adding at least 15 products to its US portfolio in FY21.

Commercial Sales & Earnings

Japan 2010s In Review: Specialize, Focus, Innovate

Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.

Japan Reimbursement

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Drug Review Drug Approval Standards
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