Organon

🇺🇸United States
Ownership
-
Established
1923-01-01
Employees
-
Market Cap
$5.7B
Website
https://www.organon.com/
patientcareonline.com
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FDA Pushes Back PDUFA Date 3 Months for Tapinarof, 1% Cream for Atopic Dermatitis

The US FDA extended the review date for tapinarof cream's sNDA for atopic dermatitis treatment to March 12, 2025. The extension was due to a major amendment requiring final datasets from the ADORING 3 trial, which showed 51.9% of participants achieved complete disease clearance with tapinarof cream.
morningstar.com
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Organon: FDA Extends Vtama Atopic-Dermatitis Review to March

Organon's FDA review for Vtama's expanded approval in atopic dermatitis extended by 3 months to March 12, impacting 2025 revenue and EBITDA margin forecasts.
jdsupra.com
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FDA Accepts aBLAs for Prolia® / Xgeva® Biosimilars from Organon and Teva

Organon announced FDA acceptance of its aBLA for HLX14, a biosimilar of Amgen’s Prolia®/Xgeva® (denosumab), licensed from Shanghai Henlius Biotech. Teva also announced FDA and EMA acceptance of its Prolia® biosimilar TVB-009P. These join Celltrion, Fresenius Kabi, and Samsung Bioepis’s denosumab biosimilar applications awaiting FDA approval. Litigations between Amgen and Celltrion, Samsung Bioepis, and Fresenius Kabi are ongoing. Sandoz’s Jubbonti®/Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia®/Xgeva®, with a U.S. market entry date by May 31, 2025, or earlier under certain circumstances.

Shanghai Henlius Biotech, Organon announce FDA acceptance of BLA for HLX14

Henlius and Organon announce FDA acceptance of BLA for HLX14, a denosumab biosimilar. The BLA is supported by comparative quality studies and clinical trials, including a Phase 1 study in China and a Phase 3 international trial. Henlius specializes in oncology and autoimmune diseases, with six products launched in China and three approved internationally.
pharmacytimes.com
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FDA Accepts Biologic License Application for Biosimilar Denosumab

The FDA accepted a BLA for HLX14, a biosimilar of denosumab, based on comparative quality and clinical studies. HLX14 met primary endpoints in a phase 3 trial, showing efficacy and safety in osteoporosis treatment. In March 2024, the FDA approved two denosumab biosimilars from Sandoz, marking the first approvals for biosimilars of Prolia and Xgeva.

Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

Regeneron loses bid to block Amgen's Eylea biosimilar, plans appeal; Prime Therapeutics adds low-cost Humira biosimilars; FDA and EMA accept Alvotech's denosumab biosimilar for review.
timmermanreport.com
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What If You Can't Pick Winners in R&D?

No one can predict pharma R&D winners; success involves luck, overcoming skepticism, and intensive effort to realize potential. R&D leaders must balance conviction with uncertainty, avoiding false precision and recognizing the role of chance.
aol.com
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EU regulator reviews anti-baldness drugs over concerns of suicidal thoughts

The European Medicines Agency is reviewing anti-hair loss drugs like Organon's Propecia due to risks of suicidal thoughts. The agency will decide whether to withdraw, suspend, or maintain marketing authorisations. Finasteride and dutasteride, known for psychiatric side effects, already carry warnings. The FDA rejected a 2022 request to remove Propecia but added a warning about suicidal thoughts.
endpts.com
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EMA reviews hair loss products following concerns about suicidal thoughts

The European Medicines Agency is reviewing finasteride and dutasteride, used for hair loss and enlarged prostate, due to concerns about suicidal thoughts. The French medicines agency requested the review, noting a 'reasonable possibility' of a link, despite no established connection. Organon, maker of Propecia and Proscar, supports the review process, while GSK's Avodart is also under scrutiny. The EMA will recommend whether these medicines' marketing authorizations should remain, change, or be withdrawn.
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