Isofol Medical AB, a small Swedish company founded a decade ago, is seeking to improve the standard of care (SOC) for metastatic colorectal cancer (mCRC), an oncology indication that receives far less attention than metastatic forms of more prevalent breast, prostate and lung cancers, said CEO Anders Rabbe. The Gothenburg-based company disclosed results from the open-label extension of its phase I/IIa study of folate receptor antagonist arfolitixorin (Modufolin) in individuals with mCRC that underpin a phase III effort that was initiated last month.
United Neuroscience Ltd. posted top-line results from a phase IIa study of UB-311, its synthetic peptide vaccine candidate targeting beta-amyloid (A-beta) for the treatment of Alzheimer's disease (AD), showing the effort met the primary aims of safety and immunogenicity with a 96 percent response rate. Secondary endpoints, which included amyloid PET burden as well as scores from Clinical Dementia Rating Scale Sum of Boxes, Alzheimer's Disease Cooperative Study-Activities of Daily Living, Alzheimer's Disease Assessment Scale-Cognitive Subscale and Mini-Mental State Exam, pointed directionally in favor of UB-311 but were not statistically significant, which the company attributed to the study sample size.
Lexicon Pharmaceuticals Inc. is seeking to close the books on the 10-year development program for sotagliflozin (previously LX-4211), its oral dual inhibitor of sodium glucose co-transporter (SGLT) 1 and 2, in type 1 diabetes (T1D). The company's pivotal phase III trial showed that individuals with T1D treated with sotagliflozin achieved statistically significant reductions in A1C at 24 weeks. Less favorable was a small incidence of diabetic ketoacidosis (DKA) in the treatment arms, an issue that has dogged SGLT2 inhibitors as a class.
Reporting at the 11th Annual T-Cell Lymphoma Forum in La Jolla, Calif., Miragen Therapeutics Inc. provided phase I data on cobomarsen in cutaneous T-cell lymphoma (CTCL) and adult T-cell leukemia/lymphoma (ATLL) along with a first look at prospects in diffuse large B-cell lymphoma (DLBCL).
The past 48 hours "have been pretty emotional and overwhelming," Bluebird Bio Inc. CEO Nick Leschly told BioWorld, and he wasn't talking about navigating the street crowd at the 37th Annual J.P. Morgan (JPM) Healthcare Conference. Between meetings in San Francisco, Leschly had fielded dozens of calls from biopharma CEOs, payer representatives, key opinion leaders, patient advocacy organizations, government officials around the world – even employees and board members – reacting to the presentation at JPM where Leschly made the case for capped, at-risk, term-limited, installment-plan payments for potentially curative gene therapy and other one-time treatments. The response across stakeholders was uniformly heartening.
The analysis of biopharma dealmaking trends by Clarivate Analytics at last year's J.P. Morgan Healthcare Conference (JPM) suggested the industry would continue to evolve rapidly as targeted therapies reshuffled the oncology space and other broad therapeutic areas – especially neuroscience and anti-infectives – faced clinical and financial headwinds. The challenge going forward, concluded Laura Vitez, commercial insights manager with Cortellis, and Jamie Munro, global practice leader, portfolio and licensing, both of Clarivate Analytics, was to generate value from deals in the face of rising costs for drug development, pushback on pricing and a shift in focus from M&A to other types of business development (BD).
Year-old startup Neurobo Pharmaceuticals Inc. plans to move lead candidate NB-01 into a phase III trial early in the second quarter that will evaluate the efficacy of the natural product-based nerve growth factor ligand modulator to treat diabetic neuropathic pain.
The analysis of biopharma dealmaking trends by Clarivate Analytics at last year's J.P. Morgan Healthcare Conference (JPM) suggested the industry would continue to evolve rapidly as targeted therapies reshuffled the oncology space and other broad therapeutic areas – especially neuroscience and anti-infectives – faced clinical and financial headwinds. The challenge going forward, concluded Laura Vitez, commercial insights manager with Cortellis, and Jamie Munro, global practice leader, portfolio and licensing, both of Clarivate Analytics, was to generate value from deals in the face of rising costs for drug development, pushback on pricing and a shift in focus from M&A to other types of business development (BD).
As participants swarm the Westin St. Francis on the first day of the 37th Annual J.P. Morgan Healthcare Conference (JPM) in San Francisco, few are likely thinking back to the after-party at the close of JPM 2016 that, shall we say, did not portray women in the most favorable light. Admonitions flew, then mea culpas, followed by a commitment from prominent investor relations consulting firm Lifesci Advisors, which co-sponsored the event, and others in biopharma to close the industry's gender gap.
Giovanni Caforio, chairman and CEO of Bristol-Myers Squibb Co. (BMS), cut to the chase in unpacking the New York-based pharma's proposed acquisition of the granddaddy of biotech, Celgene Corp., calling the match "a historic day" for both companies with "many compelling benefits."
