Endpoints News
Compounder Empower hit with another warning letter Read in browser
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22 September, 2026
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The Miss­ing Lay­er in On­col­o­gy Re­al-World Da­ta
top stories
1. Novo's CEO knows the drugmaker needs to build confidence
2. Compounder Empower receives FDA warning letter over GLP-1s
3. US trade officials hear case on declining German drug prices
4. Vertex aims for broad kidney disease label ahead of key readout next year
5. Celldex falls on safety concern, even as chronic hives drug succeeds in Phase 3 trials
6. Viking touts once-a-month maintenance data for its weight loss candidate
7.
news briefing
Amgen's Phase 3 Sjögren's win; Novartis' $900M radioligand deal
Lydia Ramsey Pflanzer
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Over in London, Elizabeth Cairns sat down with Novo CEO Mike Doustdar to talk about the drugmaker's future after its capital markets day. One quote that stuck with me from the conversation as Novo looks to the future: "We do have a plan to basically make sure that the semaglutide [loss of exclusivity] does not make this company a smaller one.”

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Lydia Ramsey Pflanzer
Deputy Editor, Endpoints News
1
by Elizabeth Cairns

LON­DON — Many in­vestors were un­der­whelmed by No­vo’s ar­tic­u­la­tion of its strat­e­gy at the com­pa­ny’s cap­i­tal mar­kets day on Mon­day, and Mike Doust­dar knows it...

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2
by Shelby Livingston

The FDA has is­sued a warn­ing let­ter to com­pounder Em­pow­er Phar­ma­cy over its GLP-1 weight loss treat­ments. It’s the third warn­ing the Hous­ton-based com­pa­ny has...

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3
by Zachary Brennan

Amer­i­can trade of­fi­cials on Tues­day heard tes­ti­mo­ny for and against an in­ves­ti­ga­tion linked to Ger­many's de­clin­ing pay­ments for drugs, as EU-based phar­ma ex­ec­u­tives are push­ing...

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4
by Lei Lei Wu

Ver­tex Phar­ma­ceu­ti­cals re­port­edthat an ex­per­i­men­tal kid­ney dis­ease drug called in­axaplin im­proved mea­sures on a urine test in two dif­fer­ent pa­tient pop­u­la­tions, rais­ing op­ti­mism ahead...

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Grand River Aseptic Manufacturing
Beyond Capacity and Cost: Strategic Decisions in Fill-Finish CDMO Partnerships
5
by Lei Lei Wu

Celldex said its ex­per­i­men­tal treat­ment bar­zolvolimab hit its pri­ma­ry end­point in two Phase 3 tri­als, even as the read­out raised safe­ty con­cerns on two life-threat­en­ing...

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6
by Max Bayer

Viking Ther­a­peu­tics says pa­tients who switched to a once-a-month dos­ing reg­i­men of its obe­si­ty drug did not re­gain much weight af­ter 12 weeks, bol­ster­ing the po­ten­tial...

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News Briefing: Quick hits from the biopharma web