Johnson & Johnson

The FDA approved Johnson & Johnson’s guselkumab (Tremfya) for treating adults with moderately to severely active ulcerative colitis (UC), based on the QUASAR study. Guselkumab, a fully-human, dual-acting monoclonal antibody, induces clinical and endoscopic remission in UC patients with inadequate response or intolerance to conventional therapy, other biologics, and/or JAK inhibitors. In the QUASAR study, 50% of patients receiving guselkumab 200 mg every four weeks and 45% receiving 100 mg every eight weeks achieved clinical remission at week 44 compared to 19% on placebo.

The implantable medical devices market, driven by chronic disease prevalence, aging population, and tech advancements, is projected to grow from $126.3 billion in 2024 to $146.81 billion by 2031, with a CAGR of 6.8%. North America leads with a 43% share due to advanced healthcare infrastructure. Key drivers include favorable reimbursement policies and technological innovations like smart implants and 3D printing. Challenges include high costs, regulatory hurdles, and device complications.

TREMFYA®, the first dual-acting IL-23 inhibitor, received FDA approval for active ulcerative colitis, showing significant endoscopic remission rates in the QUASAR program. TREMFYA® is also approved for plaque psoriasis and psoriatic arthritis.

Pharma companies should collaborate with non-profits to develop effective, tailored therapies for cancer patients, especially for rare and pediatric cancers. Cancer Research UK, through its Centre for Drug Development, partners with other non-profits to pool resources and expertise, aiming to accelerate clinical trials and improve patient outcomes. Pharma companies can contribute by sharing discontinued compounds and collaborating on clinical development.

European biotech hubs like Cambridge, Leiden, Heidelberg, and Paris excel in scientific expertise, infrastructure, entrepreneurship, and financing. Despite strong clusters, Europe lags in translating research into commercial success, unlike the U.S., where Boston/Cambridge and the San Francisco Bay Area dominate. Factors like network, funding, patents, and jobs define successful clusters. German hubs, particularly Heidelberg, Berlin, and Munich, are innovative but face challenges in collaboration and venture funding, trailing behind Paris and London.

Johnson & Johnson's Phase II SKIPPirr study of IV RYBREVANT in advanced NSCLC patients with EGFR ex19del or L858R mutations met primary endpoint of reducing infusion-related reactions (IRRs) to 22.5% with dexamethasone prophylaxis, compared to 67.4% historically. No Grade 3 or higher IRRs reported, and all IRRs were Grade 1 or 2.

Centessa Pharmaceuticals plans to rapidly advance its experimental drug after a small study showed significant increase in time to sleep in healthy volunteers. The company intends to start mid-stage studies by year-end, evaluating the drug against narcolepsy and idiopathic hypersomnia. Centessa's CEO, Saurabh Saha, noted the data exceeded expectations, leading to accelerated development. The drug targets orexin proteins, with potential for a 1 mg, once-daily treatment, comparing favorably to Takeda's candidate. The study used Maintenance of Wakefulness Tests, showing the drug restored normative wakefulness with favorable safety and tolerability.

Up to 16 new GLP-1 drugs could launch by 2029, capturing nearly a third of a $200B market by 2031, dominated by Novo Nordisk and Eli Lilly. Competitors like Roche, Amgen, Pfizer, AstraZeneca, Boehringer, Viking Therapeutics, and Structure Therapeutics may launch rival weight-loss drugs within 3-4 years. Novo Nordisk and Lilly are expected to retain 68% of weight-loss sales, but the market may see price declines of 10%-15% by 2027 due to competition.