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New Analyses Suggest Favorable Results for STELARA® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
STELARA when used as a first-line therapy was associated with longer time in clinical remission or clinical response, including the postponing of surgery, among adult patients with moderately to severely active ulcerative colitis compared with usage as a second- or third-line therapy in a modelled analysis Bio-naïve patients with moderately to severely active Crohn’s disease started on STELARA showed higher rates of persistence at one year compared to adalimumab in a retrospective real-world evidence study
Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
Recommendation informed by Phase 3 findings showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S. Johnson & Johnson COVID-19 vaccine, when given as a booster or primary dose, was generally well-tolerated FDA to decide whether to authorize a booster dose in the coming days
OPSYNVI® (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH)
Canadians living with PAH, a rare disease for which there is no cure, now have a new treatment option
Janssen Showcases Commitment to Advancing Scientific Innovation in Pulmonary Arterial Hypertension (PAH) at CHEST 2021 Annual Meeting
Combination of clinical data and real-world evidence underscores need for earlier, accurate PAH diagnosis and timelier introduction of appropriate therapy
Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
Application utilizes extrapolation-based strategy across existing breadth of STELARA data in patients living with this chronic inflammatory disease
Janssen Announces Novel Mechanism of Action that Shows Promise Against Dengue in Data Published in Nature
Early-stage research suggests potential to prevent and treat all dengue serotypes With no treatments available, dengue infects up to 400 million people each year and the pace of outbreaks is increasing.[1] This research builds on Johnson & Johnson’s work to advance science against emerging and entrenched global public health threats
Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
Submission includes data showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S. Substantial increase in immune response when booster was given at six months The Company’s single-shot vaccine has demonstrated strong and long-lasting protection and durable immune responses in clinical studies
New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications
First examination of safety events in the 60 and over sub-population across STELARA indications, including inflammatory bowel disease where relatively little biologics safety data exists, are generally consistent with placebo Janssen presents 13 abstracts, including four oral presentations and two late breakers
Janssen Announces Phase 2b Data Demonstrating its Investigational RSV Adult Vaccine Provided 80% Protection against Lower Respiratory Infections in Older Adults
Phase 2b CYPRESS study met all primary and secondary endpoints