News & Analysis as of

Johnson & Johnson FDA Approval

Knobbe Martens

Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma

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On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...more

Venable LLP

March Stelara® Biosimilar Launches: Fresenius Kabi’s Otulfi® and Celltrion’s Steqeyma™

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On March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the...more

Venable LLP

aBLA Updates: Stelara® Biosimilar Steqeyma™ (ustekinumab-stba) FDA-Approval; Lucentis® Biosimilar Xlucane™ (ranibizumab) aBLA...

Venable LLP on

On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).  Celltrion previously reached a settlement agreement...more

Parker Poe Adams & Bernstein LLP

Permanent Approval of the Pfizer COVID-19 Vaccine May Prompt Employers to Mandate Vaccinations

On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 18

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In Washington: Treasury Secretary Janet Yellen expressed confidence Wednesday that the U.S. can spend trillions more in upcoming legislation following this month’s $1.9 trillion coronavirus relief package. In testimony before...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 19

Hogan Lovells on

In Washington: The House of Representatives was set to pass its $1.9 trillion pandemic relief package (H.R. 1319), late Friday night over solid Republican opposition. The passage is a key step toward giving President Joe...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 14

Hogan Lovells on

In Washington: With only hours to spare, House and Senate lawmakers were forced to pass a last-minute short-term extension of government funding (H.J. Res. 107) to stave off a government shutdown while congressional...more

Patrick Malone & Associates P.C. | DC Injury...

$8 billion Risperdal verdict? It’s not the money, it’s the message, Big Pharma

When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and...more

Patterson Belknap Webb & Tyler LLP

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

Searcy Denney Scarola Barnhart & Shipley

Xarelto’s Approval by the FDA

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

Foley & Lardner LLP

FDA Panel Shows Strong Support for a Remicade Biosimilar

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The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

Cozen O'Connor

Whose Choice Is It Anyway? Split Decisions Over Choice of Law and The Impact On Your Defense Strategy

Cozen O'Connor on

Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, has been embroiled in a mass tort MDL in Philadelphia for its anti-psychotic drug, Risperdal, for almost a year now. So far in 2015, the juries have split – two in...more

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