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PCSK9 Pick-Me-Up: New Cholesterol Guidelines May Mean Lower LDL Targets

 
• By Emily Hayes

Sales of PCSK9 inhibitors have been improving, though are still low, and inclusion of lower LDL-C targets in practice guidelines coming this November would be a boost.

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The lower the cholesterol the better, according to a new meta-analysis of outcomes trials in JAMA Cardiology – but it remains to be seen whether this mantra will be adopted in updated practice guidelines set for release in November.

New guidelines on cholesterol levels from the American Heart Association (AHA) and the American College of Cardiology (ACC) are slated to be presented on Nov. 10 at the AHA annual meeting. They were last updated in 2013, two years prior to the approval of the PCSK9 inhibitors – Amgen Inc

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Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By Joseph Haas

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

 
• By Sushmita Panda

Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

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