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Latest From Alkermes plc

COVID-19 Will Forever Change Workplace, But Not Necessarily For The Better, Merck’s Frazier Says

Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."

Coronavirus COVID-19 Leadership

China Lays Out Requirements For Biosimilar Extrapolation

In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.

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From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots

Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.

Coronavirus COVID-19 Vaccines

US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

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