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Latest From Orphan Therapeutics, LLC
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
Tech Transfer Roundup: Tiba And CEPI Strategize Together On ‘Disease X’
Immix collaborates with Israeli research institutions on BCMA-targeted CAR-T therapy. NeoImmuneTech/NIAID alliance could pave way for “animal rule” approval in acute radiation syndrome.
Lockdown To Reopening: China Rebound Uncertain As Biotech Remains In Survival Mode
The short-notice reopening of the country made 2022 a tough year for the health sector in China, where divestments, cash crunches and commercial challenges abounded. Throughout the year, despite clinical trial activity continuing to blossom, multiple Chinese innovative drug developers faced setbacks in the US from regulatory rejections of oncology products. Meanwhile, others quietly scaled back their operations in China, hit by the negative impact of deep price cuts.
China Stockpiles Antivirals, Scraps Quarantine To Further Reopen Borders
Incoming visitors won't be required to be centrally quarantined in designated facilities starting 8 January while the national health authority also calls to stockpile three months supply of antivirals to tackle acute shortages across the nation.
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