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HLS Therapeutics, Inc.

http://www.hlstherapeutics.com/

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.

Risk Management Drug Review

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. 

Financing Business Strategies

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.

Cardiovascular Regulation

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.

Business Strategies Commercial
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
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