Evelo Biosciences Inc.’s late-stage efforts with EDP-1815 are forging ahead despite unfavorable data in atopic dermatitis (AD), and talks so far with the U.S. FDA have proven encouraging, the company said. Cambridge, Mass.-based Evelo made public findings from the first three cohorts of the phase II trial with EDP-1815 in AD, where the compound fell short of the primary endpoint: proportion of patients who achieve an outcome of at least a 50% improvement from baseline in Eczema Area and Severity Index (EASI) score compared to placebo at week 16. Evelo blamed an unusually high placebo response rate. Read More
A lot of biosimilar sponsors and wannabes will be watching as the Humira biosimilar competition unfolds in the U.S. While the competition started Jan. 31 with the launch of Amgen Inc.’s Amjevita, the true test of the strength of the competition will come in five months when other adalimumab biosimilars, including Boehringer Ingelheim GmbH’s interchangeable, hit the market. Read More
Taysha Gene Therapies Inc.’s stock (NASDAQ:TSHA) struggled Feb. 1 following the U.S. FDA’s recommendation that the company dose more patients in a double-blind, placebo-controlled study of TSHA-120 for the ultra-rare indication giant axonal neuropathy.
The ruling Communist Party of China increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance. Read More
Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle. Read More
Sirnaomics Ltd. is gearing up to start either an expanded phase IIb or a phase III clinical trial for its lead siRNA candidate, STP-705, for the treatment of two non-melanoma skin cancers: squamous cell carcinoma in situ and basal cell carcinoma. STP-705 comprises two siRNA oligonucleotides that inhibit transforming growth factor beta 1 and cyclooxygenase-2 gene expressions and is delivered via injection using what the company describes as a polypeptide nanoparticle-enhanced delivery mechanism. Read More
After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity. Read More
New hires and promotions in the biopharma industry, including: Ariceum, Aviadobio, Cadrenal, Cantargia, Carisma, Cybrexa, Infex, Nordic Nanovector, Ocugen, Providence, Rallybio, Recode, Scancell. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzecure, First Wave, Istari, Medicinova, NIAID, Oricell, Qurient, Sciwind, Skye. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abvacc, Adenomed, Adial, Biocardia, Blue Water, Cellprothera, Cidara, Endevica, Federation, Neuraxpharm, Orbit, Sanofi, Scenic, Tonix, Wuxi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Arugula, Ascletis, Deka, Fennec, Help, Idorsia, Loxo, Jazz, Reneo, Rise. Read More
