Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).In U.S. District Court in New Jersey, J&J claimed (PDF) that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims. “The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access ...
As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another legal tactic to free itself from those liabilities—suing doctors who say that its iconic baby powder can cause cancer.In federal district court in New Jersey, J&J’s talc subsidiary LTL Management has filed two suits against four doctors who authored studies that described a link between J&J’s talc-based products and cancer. Last week, J&J filed suit against New Hampshire physician Richard Lawrence Kradin and Virginia doctors Theresa Swain Emory and John Coulter Maddox. In a separate suit in May, J&J sued New York physician Jacqueline Miriam Moline. In the most recent suit, J&J claims that the three doctors cited 75 people with malignant mesothelioma who had been exposed to cancer-causing asbestos only by using Johnson’s Baby Powder or another J&J talc product, Shower to Shower. ...
Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy. After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid. With such an approval, Carvytki could leapfrog BMS’ multiple ...
Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy. The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology’s (ASCO’s) annual meeting in Chicago. “The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release. Balversa was approved on an accelerated basis in 2019, becoming the first ...
Johnson & Johnson’s consumer health business is valued at $40 billion ahead of its initial public offering later this year, according to a report by The Wall Street Journal. The soon-to-be spinoff Kenvue aims to raise $3.5 billion or more in the offering, people familiar with the matter told the Journal. The newspaper noted that “the share sale would be by far the biggest of what so far has been a quiet year for IPOs.” Kenvue plans to meet with prospective investors as early as Monday, the sources told the Journal. When asked about the Journal’s report, J&J spokesperson Tesia Williams told CNBC, “Unfortunately, I do not have any information to provide.” J&J previously said it expects to complete the separation from Kenvue by mid- to late 2023. The consumer staples giant has also said it will retain majority ownership of Kenvue, with ...
Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Following a recommendation from the European Medicines Agency, the European Commission has officially approved J&J’s Akeega in metastatic castration-resistant prostate cancer (mCRPC), J&J said Friday. The drug is a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga, and it’s used alongside a corticosteroid. Under a 2016 deal with Zejula’s developer Tesaro, J&J specifically carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. Not all patients can get Akeega under the drug’s European label. To be eligible, a patient’s tumor must test positive for BRCA1/2 mutations, which account for 10% to 15% of all cases, J&J said. Akeega’s label in Europe is narrower than that of rival PARP inhibitor Lynparza from AstraZeneca and Merck. The European Commission in December cleared Lynparza and Zytiga for mCRPC ...
After the disclosure from AstraZeneca that it’s under Justice Department scrutiny for illegally funding Iraqi terrorism, Roche and Johnson & Johnson revealed similar inquiries from the agency.
Johnson & Johnson is moving out from the diabetes business and sold its Calibra product (marketed as OneTouch Via, but never launched) to a 10-year-old company named CeQur, which was already working on a similar insulin-delivery wearable. The terms and conditions of this deal have not yet been yet disclosed, but CeQur has attained an exclusive worldwide license for this technology.
Johnson & Johnson has once again won in its appeals campaign against talcum powder verdicts. Last year, the company had secured two reversals. In this year, the Missouri Court of Appeals reversed another verdict in Gloria Ristesund’s case worth $55 million, where the court lacked jurisdiction.
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