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Latest From Alkermes plc
US FDA Urged To Improve Messaging To Professional Societies On Accelerated Approval Withdrawals
Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.
Medicare Wastage Rebate Exceptions For Small Volume Products, Cell/Gene Therapy Urged
Packaging for such products reflects ‘unique circumstances’ that should exempt them from the rebates on discarded drugs otherwise required by the policy, stakeholders tell CMS at a ‘town hall’ forum.
Axogen, Dario Health, Biobeat, Immunexpress All Weigh In On 2022 And What Will Succeed In 2023
Medtech Insight was invited to ask questions at a roundtable event organized by Russo Partners to review the major medtech industry trends of 2022 and what to expect in 2023.
Kabi: US Pegfilgrastim Crowd Is An Opportunity For Us, Not A Deterrent
In the second part of Generics Bulletin’s exclusive interview with Fresenius Kabi’s senior vice president for biosimilars in the US, Ali Ahmed, he explains why Kabi is relishing the prospect of competing in pegfilgrastim and what the acquisition of mAbxience means for the company’s prospects and vision.
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