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PCSK9 Sales Still Slow, But May Get Boost From Label, Guideline Changes

 
• By Emily Hayes

Amgen's report of higher sales and news of priority review for an outcomes benefit claim for Repatha bode well, but a negative JAMA editorial is another knock on the PCSK9 inhibitor class.

Cholesterol plaque in artery

Amgen Inc.'s Repatha and Sanofi/Regeneron Pharmaceuticals Inc.'s Praluent are still struggling to get off the ground – but there is hope ahead for the PCSK9 inhibitors in terms of better labeling and better positioning in treatment guidelines for cholesterol reduction due in early September.

In its July 31 second-quarter earnings release, Sanofi reported €42m ($50m) in sales for Praluent (alirocumab), following Amgen's report of...

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Psoriasis Submissions Iin The Bag, J&J Advances Icotrokinra Into Phase III For Ulcerative Colitis

 
• By Kevin Grogan

The company has presented the full set of positive results from the Phase IIb ANTHEM-UC trial in the inflammatory bowel disease.

Boehringer’s Jascayd Approval Brings New Mechanism To IPF

 
• By Jessica Merrill

The PDE4B inhibitor brings a new mechanism of action to the challenging respiratory disease and is the first drug approved for the indication in more than a decade.

Galderma Punches Above Its Weight Against Dermatology Goliaths

 
• By Kevin Grogan

The Swiss group is more than holding its own against Dupixent for prurigo nodularis and is looking to make further inroads into Sanofi and Regeneron's blockbuster's market share in atopic dermatitis.

Pipeline Watch: Five Approvals And 15 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.

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Psoriasis Submissions Iin The Bag, J&J Advances Icotrokinra Into Phase III For Ulcerative Colitis

 
• By Kevin Grogan

The company has presented the full set of positive results from the Phase IIb ANTHEM-UC trial in the inflammatory bowel disease.

Hope Medicine Ready To Bring Potential First-in-Class Endometriosis Treatment Into Phase III

 
• By Andrew McConaghie

The non-hormonal drug could be a big step forward in treating pain associated with the condition, but the Chinese company may still need a partner for its Phase III studies and eventual commercialization.

Sakaguchi’s Nobel Brings Cheer To Japan Biopharma

 
• By Lisa Takagi

Japan's latest Nobel Prize win sparks hopes for renewed investment in biopharma R&D by the national government, including in a venture co-founded by the winner.