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The decision by health technology assessment body NICE on Novartis’s advanced breast cancer drug, Kisqali, contrasts sharply with its recommendation for another CDK4/6 inhibitor – Lilly’s Verzenios.
Merck & Co. executive outlines how the company could sustain a “compliant supply performance” amid the pandemic, while senior officials from Sun Pharma, Cipla, Zydus Cadila and Biocon shared insights on coping with supply chain turbulence and moving away from over-dependence on China for starting materials.
Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.
Novartis and Takeda’s R&D efforts saw an impact from the COVID-19 pandemic, but both Lutz Hegemann and Andrew Plump believe that when the next pandemic hits, the industry and regulators will be better prepared for it.
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- Other Names / Subsidiaries
- Clarient Inc.
- Asymptote Limited
- GE Healthcare
- GE Medical Systems LLC
- Monica Healthcare
- Novia Strategies
- Vital Signs.