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Ironwood Pharmaceuticals, Inc.

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Latest From Ironwood Pharmaceuticals, Inc.

Closed-Loop Inspections? Strict COVID Zero Policy Delays US FDA’s China Field Trips

Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a ‘quarantine bubble’ like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

China Manufacturing

Closed-Loop Inspections? Strict COVID Zero Policy Delays FDA's China Field Trips

Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a "quarantine bubble" like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

China Manufacturing

Homegrown China Oral Antiviral Shows Early Promise

Junshi’s oral antiviral shows signs of effectiveness in treating patients with mild COVID-19 symptoms but more data are needed, caution researchers.

China Coronavirus COVID-19

Going Global Gets Stuck, Chinese Drug Makers CRL Show What Not To Do

Chinese drug makers have more to lament and plenty to learn from as Junshi, HutchMed follow Innovent Bio with FDA rejections. A holistic not opportunistic approach is needed, one ex-FDA expert suggests.

Drug Review Regulation
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