Johnson & Johnson
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1886-01-01
- Employees
- 131.9K
- Market Cap
- $392.2B
- Website
- http://www.jnj.com
- Introduction
Johnson & Johnson is a holding company, which engages in the research, development, manufacture, and sale of products in the healthcare field. It operates through the Innovative Medicine and MedTech segments. The Innovative Medicine segment focuses on immunology, infectious diseases, neuroscience, oncology, cardiovascular and metabolism, and pulmonary hypertension. The MedTech segment includes a portfolio of products used in the interventional solutions, orthopaedics, surgery, and vision categories. The company was founded by Robert Wood Johnson I, James Wood Johnson, and Edward Mead Johnson Sr. in 1887 and is headquartered in New Brunswick, NJ.
FDA Approves Stelara Biosimilar Ustekinumab-aauz (Otulfi)
FDA approves Fresnius Kabi and Formycon’s ustekinumab biosimilar, ustekinumab-aauz (Otulfi), for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresnius Kabi’s fourth biosimilar product in the U.S. market, reflecting their commitment to broadening their biopharma portfolio globally.
Fresenius Kabi wins FDA approval for Stelara biosimilar Otulfi
Fresenius Kabi and Formycon receive FDA approval for Otulfi, a Stelara biosimilar, marking Fresenius Kabi's fourth biosimilar approval in the US. Otulfi treats Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis. Stelara sales are expected to drop to $1.2bn by 2030 due to biosimilars.
Halda Therapeutics Appoints Veteran Biopharma Leader, Christian Schade, as President
Halda Therapeutics appoints Christian Schade as CEO, aiming to advance RIPTAC™ therapeutics for cancer treatment.
FDA Approval Sought for Subcutaneous Daratumumab Plus VRd in Transplant-Ineligible
An sBLA for daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients was submitted to the FDA. Supported by phase 3 CEPHEUS trial data, D-VRd showed higher minimal residual disease (MRD)–negativity and complete response rates compared to VRd alone. If approved, D-VRd would be the first FDA-approved treatment based on MRD-negativity rate as a primary endpoint.
Related Clinical Trials:
Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi
Fresenius Kabi and Formycon AG announced FDA approval of Otulfi™, a ustekinumab biosimilar referencing Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi™ is Fresenius Kabi’s fourth biosimilar in the U.S., expanding its immunology and oncology portfolio.
Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet
Johnson & Johnson submits sBLA to FDA for DARZALEX FASPRO® quadruplet regimen for newly diagnosed multiple myeloma patients, supported by CEPHEUS study showing 60.9% MRD-negativity and 43% reduced risk of progression or death.
Related Clinical Trials:
FDA approves Otulfi as fourth Stelara biosimilar for chronic inflammatory diseases
FDA approves Otulfi, a fourth Stelara biosimilar, for chronic inflammatory diseases including Crohn’s and ulcerative colitis, expected to be available in the U.S. by February.
Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
FDA approves ustekinumab-aauz (Otulfi), the fourth ustekinumab biosimilar referencing Stelara, for Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi, developed by Formycon and Fresenius Kabi, was also approved by the European Commission. Due to settlements, Otulfi and other ustekinumab biosimilars will launch no earlier than February 22, 2025.
Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM
Formycon and Fresenius Kabi receive FDA approval for FYB202/Otulfi™ (ustekinumab-aauz), a biosimilar to Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Formycon's third successful FDA approval for a biosimilar, with Fresenius Kabi set to market Otulfi™ in the US by February 22, 2025, under a patent settlement with Johnson & Johnson.
J&J Posts Positive Phase III Results for Carvykti and Darzalex Faspro in Multiple Myeloma Trials
J&J announced positive clinical trial data for its multiple myeloma drugs Carvykti and Darzalex Faspro, showing improved outcomes. Carvykti demonstrated a 45% reduction in death risk and 76% OS rate at 30 months, while Darzalex Faspro improved minimal residual disease-negativity by 60.9%.
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