American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey; ranks No. 42 on the Fortune 500 list with an AAA credit rating.
相关临床试验
9
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1886
已完成
3
33.3%
尚未招募
2
22.2%
招募中
1
11.1%
终止
1
11.1%
Unknown
1
11.1%
撤回
1
11.1%
暂无批准数据
- Once-daily CAPLYTA 42 mg produced a statistically significant 4.8-point greater reduction in YMRS total score versus placebo at Week 3 in adults with bipolar I mania. - Significant separation from placebo was observed as early as Day 3 and sustained through Week 3, with 45.8% of treated patients achieving clinical response versus 20.9% on placebo. - The key secondary endpoint of Clinical Global Impression-Severity also favored lumateperone, and the safety profile was consistent with the drug's established tolerability. - A second pivotal Phase 3 study, Study 452, has been completed with data analysis underway, and J&J plans to discuss a potential mania filing with regulators.
- The EMA's CHMP recommended 12 new medicines for approval at its September 14-17, 2026 meeting, alongside 11 therapeutic indication extensions and two biosimilars. - Povofortay (povorcitinib) became the first oral daily treatment recommended for adults with moderate to severe hidradenitis suppurativa refractory or intolerant to anti-TNF therapy. - Johnson & Johnson's Tecvayli (teclistamab) won support for earlier-line multiple myeloma use, with MajesTEC-3 data showing a 71% reduction in progression risk versus standard of care. - Two initial marketing applications were withdrawn, for apitegromab in 5q spinal muscular atrophy and trilaciclib in extensive-stage small-cell lung cancer, while three negative opinions entered re-examination.
- The EMA's CHMP has recommended extending TECVAYLI (teclistamab) approval to adults with relapsed/refractory multiple myeloma after at least one prior therapy. - The recommendation rests on the Phase 3 MajesTEC-9 study, in which teclistamab monotherapy cut the risk of disease progression or death by 71% versus standard of care. - Teclistamab also reduced the risk of death by 40% and produced a complete response or better in 65.9% of patients versus 16.8% with PVd or Kd. - The opinion follows European Commission approval of teclistamab plus daratumumab in the same second-line setting, based on the MajesTEC-3 study.
- The Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in major depressive disorder failed to meet its primary MADRS efficacy endpoint at Day 5 versus placebo. - The M1 receptor antagonist was well tolerated with no new safety signals, and Johnson & Johnson is still analyzing prespecified exploratory endpoint data. - The miss is the second Phase 2 failure for the molecule, following the VISTA trial in relapsing-remitting multiple sclerosis in 2025. - Analysts removed the asset from financial models, shifting Contineum's valuation focus to its wholly owned LPA1 antagonist PIPE-791 for idiopathic pulmonary fibrosis.
- Johnson & Johnson now requires all 340B providers to submit pharmacy or medical claims data for each dispensed drug to receive point-of-sale discounts. - Providers failing to submit documentation within 45 days could have all their 340B discounts suspended, forfeiting savings of 20% to 50%. - Hospital groups argue drugmakers lack statutory authority to impose reporting requirements and have urged federal regulators to intervene. - The policy escalates a broader conflict as 340B purchases reached $100 billion in 2025, up nearly 23% year over year.
- A modeling study in The Lancet projects Medicare's most-favored-nation pricing policy would cut spending by $5.2 billion under GLOBE and $6.4 billion under GUARD in its initial phase. - For roughly three in four medicines studied, Medicare savings would approach four times that drug's entire annual sales in the reference country, creating incentives to alter pricing abroad. - Reported confidential agreements with 17 manufacturers could reduce the policy's projected Medicare savings by 71 percent, according to the analysis. - The White House separately announced that all 50 state Medicaid programs will receive most-favored-nation rebates on brand-name drugs, with taxpayer savings estimated at $64.3 billion over a decade.
- GSK has secured full global rights to Chimagen Biosciences' unnamed trispecific T-cell engager for multiple myeloma in a deal worth up to $750 million. - The preclinical asset is designed to bind T cells while targeting two tumor-associated antigens, aiming for deeper responses and better tolerability than existing engagers. - GSK plans to begin Phase 1 testing in 2027, adding to a myeloma portfolio anchored by the BCMA-directed antibody-drug conjugate Blenrep. - The deal is GSK's second with Chimagen, following the 2024 licensing of the CD19/CD20-targeted T-cell engager CMG1A46 for B-cell malignancies and autoimmune disease.
- Celltrion has submitted an IND application to the FDA for a U.S. Phase 4 trial of a 240mg high-dose regimen of its subcutaneous infliximab, Zymfentra. - The trial will enroll 447 patients with Crohn's disease and ulcerative colitis across 55 U.S. sites, testing non-inferiority against high-dose intravenous infliximab. - Success would add a 240mg option to the current 120mg U.S. prescribing practice, mirroring a high-dose strategy that helped Remsima SC reach roughly 32% EU5 market share. - Zymfentra first-half sales reached 99.5 billion won (about $73.6 million), up 176.4% year-over-year, while a global trial to add a rheumatoid arthritis indication continues.
- Final Phase 3 PAPILLON data show first-line RYBREVANT plus carboplatin-pemetrexed achieved median overall survival of 34.3 months versus 27.9 months with chemotherapy alone in EGFR exon 20 insertion NSCLC. - A prespecified crossover-adjusted analysis showed a significant survival benefit, reducing the risk of death by 43 percent (HR 0.57; 95% CI 0.39-0.82; nominal P=0.003). - The combination extended progression-free survival through second disease progression by more than 10 months (28.3 vs 17.5 months; HR 0.59; nominal P<0.0001). - Results were presented at the IASLC 2026 World Conference on Lung Cancer and represent the longest reported median overall survival in this historically poor-prognosis population.
- All 24 patients with inoperable, locoregionally recurrent NSCLC completed radiotherapy-activated JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities and no related Grade 3 or higher events. - At a median 12-month follow-up, one-year locoregional control reached 79%, one-year local progression-free survival 61% and one-year overall survival 70%. - Investigators concluded the hafnium oxide nanoparticle radioenhancer may permit clinically meaningful local control at a substantially lower re-irradiation dose than patients' prior radiotherapy course. - Enrollment in the dose-escalation and expansion phases is complete per protocol, and additional patients are now planned following the encouraging findings.
