Johnson & Johnson

Alvotech and Teva announce FDA approval of Selarsdi (ustekinumab-aekn) in a new 130 mg/26 mL presentation, expanding its label to align with Stelara® (ustekinumab) indications. The U.S. launch is expected in Q1 2025, following successful biosimilar ustekinumab launches in Canada, Japan, and Europe.

A grandfather and grandson invented a new antibiotic class in a Perth garage, now in phase-3 trials, addressing antibiotic resistance. Recce Pharmaceuticals' R327, developed by James Graham and his grandfather, has shown promise in treating various infections, including those resistant to other antibiotics. The drug has undergone Phase-2 trials in Australia and is in Phase-3 trials in Indonesia, with plans for US trials. The global antibiotic market is growing, and R327 aims to address unmet needs.

Asthma drug market focuses on quick-relief and long-term control meds; market driven by asthma prevalence, research advancements, and improved diagnostics; projected to reach $64.6 billion by 2033; major companies include Abbott, Merck, GSK, Novartis, Johnson & Johnson, Bristol-Myers Squibb, Sanofi, Pfizer, Teva, and AbbVie.

Accord Healthcare's Imuldosa, a biosimilar of Stelara (ustekinumab), received a positive opinion from the EMA's CHMP, strengthening Accord's autoimmune franchise and portfolio. Ustekinumab targets cytokines IL-12 and IL-23, crucial in inflammatory responses. Stelara has global sales of $19 billion, with $3.2 billion from Europe.

Generative AI is transforming pharma by automating labor-intensive tasks, aiding drug discovery, optimizing clinical trials, and predicting patient outcomes. Despite high upfront costs, AI's value lies in faster, more efficient, and successful trials, potentially leading to leaner, tech-savvy pharma companies with new business models.

The Business Research Company's report on the Global Lab Automation In Genomics Market forecasts growth from $2.01 billion in 2023 to $4.17 billion in 2028 at a CAGR of 15.7%, driven by precision medicine and automated genomic sequencing technologies.

Roche refocuses R&D on obesity, Alzheimer's, and other major diseases to align with healthcare budget demands and market potential, following the success of drugs like Ozempic and Wegovy.

Nipocalimab, a monoclonal antibody, showed promising results in the phase 3 VIVACITY-MG3 trial for generalized myasthenia gravis (gMG), meeting primary and secondary endpoints with a rapid and maintained reduction in MG-ADL scores. The treatment was well-tolerated with no new safety signals. Presented at the 2024 AANEM meeting, the study highlights nipocalimab's potential as a steady, IV-administered option for gMG, contrasting with currently available cyclical treatments.

Accord Healthcare announces CHMP's positive opinion for Imuldosa, a biosimilar of Stelara, based on comprehensive data confirming therapeutic equivalence and safety. This paves the way for EU authorization in a market valued at EUR2.9 billion. Intas holds exclusive global rights, excluding Japan, Korea, and certain Asian countries.

The FTC's 2023 revised merger guidelines impact pharmaceutical industries with stricter HHI and market share requirements, emphasizing direct evidence of market dominance and ecosystem competition. The FTC scrutinizes pharmaceutical mergers for market concentration, innovation, and entry barriers, with ongoing investigations into Novo Nordisk/Catalent and AbbVie/Cerevel mergers. The EC investigates Zoetis for potential abuse of dominance post-merger, and the FTC challenges fraudulent patents to prevent market monopolization. Pharmaceutical companies are increasingly merging with biotech firms to offset patent expirations and enhance product portfolios.