BOTOX alternative to face delays? Evolus' CMO hit with Form 483
Ten manufacturing violations at a South Korean CMO facility could delay US FDA approval of a BOTOX alternative, says Evolus.
Archives for January 26, 2018
US FDA to take risk-based approach to biomanufacturing inspections
A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the US FDA says.
Shire secures Cinryze supply with tech transfer to Austria
The US FDA has approved Shire’s request to make rare genetic disease treatment Cinryze at its manufacturing facility in Vienna.
J&J Q4: Pricing pressures drive 9% drop in US Remicade sales
J&J has reported its largest quarterly decline in US Remicade (infliximab) sales, but says demand remains stable amid biosimilar competition.