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Cyprium Therapeutics Inc.

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Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

US FDA Performance Tracker Drug Review

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Zydus Lifesciences is building a rare disease-focused pipeline as a differentiating strategy, managing director Sharvil Patel tells Scrip in an interview. Innovation and patient centricity at heart, digital initiatives are being implemented to transform the company into a ‘future ready’ healthcare organization

Commercial Business Strategies

Zydus Claims Top Spot In India Biosimilars With Kadcyla, Sees 40-50% Growth

Zydus Cadila sees 40-50% growth continuing in its biosimilars business, with plans for launches in Latin America. Its Kadcyla biosimilar is faring well and after helping the company gain the top spot in India, could also move to clinical trials in the US.

Commercial Sales & Earnings

Keeping Track: Spectrum Submits Poziotinib; US FDA Approves Daré’s Xaciato, Expands Heron Zynrelef Label

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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