HLS Therapeutics, Inc.
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Latest From HLS Therapeutics, Inc.
Clozapine REMS Program Paused After Problems With Re-Certification
US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.
Finance Watch: Billions Flow Into Biopharma Via Three New Investment Funds
Blackstone raised $3.44bn of a $4.58bn life science fund, while HealthCare Royalty Partners raised $1.8bn and MVM closed a $325m fund. Also, 20 private drug developers raised $20m or more, but three public biopharma firms unveiled restructuring plans.
Vascepa Included In European Dyslipidemia Guidelines Ahead Of Approval
Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.
Amarin Will Double Vascepa Sales Team In Big Bet On Supplemental Approval
Anticipating a label expansion this fall based on the REDUCE-IT cardiovascular outcomes study, Amarin will double its sales force and has raised revenue guidance. Approved to reduce very high triglyceride levels, Vascepa sales total $170m-$174m so far this year.
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