ABBVIE

AbbVie announced updated results from the Phase 1b/2 EPCORE NHL-2 trial showing 96% overall response rate and 87% complete response rate with epcoritamab + lenalidomide + rituximab in relapsed or refractory follicular lymphoma patients, with 89% of complete responders remaining in CR at 18 months.

Filgotinib, an oral JAK inhibitor, met only one of four primary endpoints in a phase III Crohn's disease trial, possibly due to study design issues. Clinical remission was achieved by more patients previously treated with biologics, but endoscopic response was not met. Maintenance phase showed better results, with clinical and endoscopic remission rates improving. Study limitations included early endoscopic assessment and high placebo response rates.

BioArctic has initiated the Phase IIa EXIST trial, dosing the first subject with the monoclonal antibody exidavnemab to treat Parkinson’s disease. The trial, conducted in Europe, aims to assess the antibody's tolerability and safety, with a focus on biomarkers. Exidavnemab is developed to potentially halt or slow Parkinson’s progression by targeting alpha-synuclein. BioArctic, known for neurodegenerative disease treatments, collaborates with AbbVie and Eisai.

DelveInsight's report on the Obsessive Compulsive Disorder (OCD) market forecasts a significant CAGR growth from 2020-2034, driven by increasing prevalence and awareness, and the launch of multiple-stage pipeline products. The market was valued at approximately USD 1000 million in 2023, with 12,082,000 prevalent cases of OCD across 7MM in 2022, expected to rise by 2034. Key companies include Biohaven Pharmaceuticals, Inc., AbbVie, AstraZeneca, and others, with therapies such as Troriluzole, Fluvoxamine maleate, and BHV-4157. The report provides insights into epidemiology, market trends, and treatment scenarios in the US, EU4, and Japan.

Treg sector sees significant investments and collaborations, positioning Treg therapies as a breakthrough in autoimmune and inflammatory disease treatments. The 7th Treg-Directed Therapies Summit (March 25-27, 2025, Revere Hotel, Boston) offers insights into Treg biology and clinical advancements.

The ARANOTE trial demonstrated that darolutamide plus androgen-deprivation therapy (ADT) without chemotherapy improved radiological progression-free survival by 46% in metastatic hormone-sensitive prostate cancer (mHSPC) patients compared to placebo plus ADT (HR 0.54, 95% CI 0.41-0.71, P<0.0001). The combination showed consistent benefits across subgroups, including high- and low-volume disease, and improved overall survival (OS) rates at 24 months (79.8% vs. 75.5%). Darolutamide also exhibited better tolerability with lower rates of fatigue and adverse event-related discontinuation compared to placebo.

EFPIA highlights EU's roadmap for precision oncology to address rising cancer burden, despite forecasted mortality rate declines. Stakeholder roundtable in Brussels aims to improve personalized cancer treatment. EU initiatives, including AI-powered cancer care and the DigiONE pilot, aim to advance precision medicine. A gold-standard cancer data management system is necessary for innovative precision medicine access, emphasizing standardized data formats, robust privacy, and professional education.

FDA grants Merck's sacituzumab tirumotecan (sac-TMT) breakthrough therapy designation for advanced non-squamous NSCLC with EGFR mutations, post-chemotherapy progression. This marks the first BTD for sac-TMT, an ADC developed with Kelun-Biotech, with Merck holding global marketing rights except in Greater China.

Edidiong Etim's doctoral dissertation proposal defense at Francis College of Engineering focuses on computational and experimental analysis of a photo-ECMO device for CO poisoning and a cryolipolysis device for fat reduction, addressing gaps in their development and mechanisms.

Intra-Cellular Therapies seeks FDA approval for Caplyta as an adjunct treatment for major depressive disorder (MDD), potentially expanding its market to over $1 billion. Caplyta, already approved for schizophrenia and bipolar disorder, saw Q3 sales of $175 million, with Q4 projections at least $193 million. The MDD submission is based on Phase III trials showing symptom improvement when paired with an antidepressant. Jefferies estimates a 90–95% approval likelihood, predicting a company valuation of $9–12 billion. Intra-Cellular is also exploring Caplyta for autism and developing ITI-214 for Parkinson’s and ITI-333 for opioid use.