Johnson & Johnson

Biosimilars face barriers in the US, including the patent system, interchangeability, and PBM policies. The 'patent dance' under the BPCIA aims to expedite biosimilar market entry but is criticized for being cumbersome. Patent litigation often leads to biosimilar launch delays, as seen with adalimumab and ustekinumab biosimilars. Policy reforms, such as the Affordable Prescriptions for Patients Act, aim to address these issues but face legislative challenges.

Innovation in neuropsychiatry is reviving after 40 years of dormancy, with recent approvals like Bristol Myers Squibb’s Cobenfy and Sage Therapeutics’ Zurzuave. Large Phase III studies on psychedelics aim to shift from anecdotal to evidence-based treatments. Challenges include high costs of Phase III trials and lack of effective animal models for CNS disorders. Investment in neuroscience is cyclical, with a need for better patient selection and biomarkers. Infrastructure and less intrusive diagnosis methods, like blood-based biomarkers, are crucial for tackling neurodegenerative diseases. AI and analytics advancements could improve diagnostic efficiency and patient targeting, despite regulatory hurdles and mixed public perception in neuropsychiatry.

The article discusses the challenges sponsors face with outsourced monitoring in clinical trials, emphasizing the need for stricter oversight and potential solutions, including reclaiming in-house monitoring to ensure patient safety and data integrity.

Johnson & Johnson submits regulatory applications to FDA and EMA for Darzalex Faspro as monotherapy for high-risk smoldering multiple myeloma, supported by AQUILA study data. Smoldering multiple myeloma, an early precursor to active multiple myeloma, currently not treated until progression, but high-risk patients may benefit from early intervention. First AQUILA study data to be presented at 2024 ASH Annual Meeting.

Nipocalimab receives FDA Breakthrough Therapy designation for treating moderate-to-severe Sjögren’s disease, marking the first such designation for this condition. The decision is supported by Phase 2 DAHLIAS study data, which showed positive results for nipocalimab as a potential therapy.

Roflumilast cream 0.15% showed high efficacy in treating mild to moderate atopic dermatitis in patients aged 6 years and older, with more patients achieving a validated IGA-AD score of 0/1 and minimal application site irritation.

The FDA proposes removing oral phenylephrine, a decongestant in many OTC cold and flu meds, due to concerns over its effectiveness. Phenylephrine, used since 1976, replaced pseudoephedrine in 2006. Studies show no difference between phenylephrine and placebos for congestion relief. CVS removed oral phenylephrine products in 2023. The FDA notes phenylephrine is more effective when applied directly to the nose.

Johnson & Johnson reports positive phase 3 data for Darzalex in smouldering multiple myeloma, filing applications in Europe and US. Darzalex Faspro, a subcutaneous injection, could be the first treatment option for this pre-cancerous condition. Based on AQUILA study results, Darzalex Faspro showed significant PFS reduction and ORR improvement compared to active monitoring. Darzalex, already a $9.7 billion drug, aims to maintain its lead over Sanofi's Sarclisa in the multiple myeloma market.

Johnson & Johnson submits regulatory applications to FDA and EMA for DARZALEX FASPRO as monotherapy for high-risk smoldering multiple myeloma, supported by Phase 3 AQUILA study data. The first AQUILA study results will be presented at the 2024 ASH Annual Meeting.