Investors in Minerva Neurosciences Inc. on Dec. 1 gave a chilly reception to reported FDA feedback on the company's experimental treatment for the negative symptoms in schizophrenia, roluperidone. Though the drug failed to deliver statistically significant differences vs. placebo in a phase III study this year, CEO Remy Luthringer outlined a potential path to NDA filing for the candidate using a modified intent-to-treat analysis of the trial and evidence from other ongoing evaluations. Read More
Despite challenges tossed at the phase III study of mitapivat from Agios Pharmaceuticals Inc. by COVID-19, top-line data showed the oral therapy hit its primary endpoint in treating adults with pyruvate kinase (PK) deficiency who don’t receive regular transfusions. Read More
DUBLIN – Noema Pharma AG closed a €54 million (US$59.8 million) series A round to take forward four clinical-stage assets it has in-licensed from Roche Holding AG. The drug candidates are being lined up for orphan neurological indications that fall outside of Roche’s strategic focus. Read More
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. is acquiring Scintec Diagnostics GmbH subsidiary Therapharm GmbH in a deal worth AU$33 million (US$24.24 million) plus royalties.
Zug, Switzerland-based Therapharm has developed a portfolio of radiolabeled diagnostic and therapeutic products, and the deal brings Telix a new targeting asset in hematology, Telix CEO Chris Behrenbruch told analysts during a Dec. 1 conference call. Read More
LONDON – The 10 weeks of laboratory time lost during the first U.K. COVID-19 lockdown will translate to a 17-month delay in oncology drug discovery and development projects, according to the Institute of Cancer Research (ICR) in London. Read More
Shenzhen Xbiome Biotech Co. Ltd., an artificial intelligence (AI)-based microbiome drugmaker, raised more than $20 million in a series B+ round, Xbiome CEO Yan Tan told BioWorld, financing that will help the company launch its phase I trial next year. It has been a year since the drugmaker closed a $14 million series B round. During this period, Tan said Xbiome submitted an IND to the FDA in October for its fecal microbiota transplant (FMT) capsule candidate, a potential treatment for graft-vs.-host disease. Read More
Despite concerns to the contrary, none of the mutations currently documented in the SARS-CoV-2 virus appear to increase its transmissibility in humans, according to a new analysis of viral genomes from 46,723 people in 99 countries who contracted COVID-19. Read More
The already intriguing IL-2 pathway as a therapeutic target gained still more traction after San Francisco-based Nektar Therapeutics Inc. unveiled melanoma data with bempegaldesleukin (bempeg), its CD122-preferential agent in the class. Read More
Personalized medicine, also referred to as precision or targeted medicine, continues to have a significant impact on the treatment of diseases, particularly cancer. Over the past decade or so there has been a dramatic surge in research and development investments in this field. According to the Washington-based Personalized Medicine Coalition, there are about 286 such medicines on the market currently, a number that has more than doubled from the 132 that were available in 2016, representing the largest four-year increase since the PMC began tracking personalized therapies back in 2008. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine. Read More
BioWorld looks at translational medicine, including: Overfeeding slows down liver’s response to glucose changes; Oncolytic virus combines best of both immune worlds. Read More
