2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections
US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.
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CRLs In 2019: Steady In Number, But Biosimilar Performance Improves
The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.
EU CHMP Backs Three Conditional Approvals & Several Treatment Firsts
Akcea’s Waylivra, Portola’s Ondexxya, BioMarin’s Palynziq, AbbVie’s Skyrizi and Pfizer’s Lorviqua are among new drugs to receive a positive opinion from the EU’s CHMP at its latest monthly meeting.
Risankizumab, Andexanet Alfa & GSK’s IV Zanamivir Up For CHMP Opinion
Opinions on whether new products for the treatment of conditions such as psoriasis, coagulation reversal, flu and diabetes should be granted an EU marketing authorization are due this week as the EMA’s key scientific committee, the CHMP, meets for the last time in London..