The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency." Read More
9 Meters Biopharma Inc., of Raleigh, N.C., is newly born from the merger of Innovate Biopharmaceuticals Inc. and privately held RDD Pharma Ltd., of New York and Tel Aviv, Israel. About $22 million in new financing, led by Orbimed Advisors Ltd., and the signing of another merger into the new company of Richmond, Calif.-based Naia Rare Diseases Inc., which develops GLP-1 to treat short bowel syndrome, completes 9 Meters’ new path. Read More
With regard to agitation in Alzheimer’s disease (AD), doctors “are in a very difficult position right now,” said Axsome Therapeutics Inc. CEO Herriot Tabuteau. That’s because the products currently used off-label are antipsychotics – all of which carry an FDA black box warning “specifically against their use in elderly patients with dementia, including AD,” since they double the risk of stroke and of mortality. Read More
The activity of many proteins is controlled through phosphorylation by kinases and dephosphorylation by phosphatases. Overactive kinases are one of the major drivers of tumors and, as a result, kinase inhibitors are a mainstay of oncology drug development. But “activation of the brakes, the phosphatases, could be equally therapeutically viable for the treatment of a broad range of cancers” to kinase inhibition, Goutham Narla told the audience at the 2020 American Association for Cancer Research (AACR) meeting. Read More
CEO and co-founder Rosana Kapeller told BioWorld that Rome Therapeutics Inc.’s $50 million series A will fund early work in an “exploding” new area of biology: the repeatome – “the dark genome” or “junk DNA,” as many previously deemed the roughly 60% of the human genome that consists of repetitive sequences of nucleic acids. Read More
Citing "known and potential benefits" of using Gilead Sciences Inc.'s remdesivir for the treatment of COVID-19 that "outweigh the known and potential risks of the drug's use," the FDA has issued an emergency use authorization (EUA) for the antiviral, currently in limited supply, according to the company. Gilead CEO Daniel O’Day, who said the company is working with partners across the globe to ramp up supply, said his team is working with "urgency and responsibility" to meet global needs for the medicine. Read More
BioWorld looks at translational medicine, including: Neutralizing RSV; Insulin cuts both ways in vasculature; Transcriptomic insights into Parkinson’s disease; Restoring synaptic transmission for rare neurodevelopmental disease; Polymerase k and drug resistance; Sphingolipids accumulate in neurodegeneration; How does innate immunity remember? Not via polycomb; Antibiotics affect oxycodone effects; Cabo as next annual shot? Read More
Even as the world grapples with COVID-19, researchers and public health officials are trying to apply its lessons to future outbreaks. In our series “The next pandemic,” BioWorld explores the strategies and technologies that could improve the fight against future outbreaks, from robust surveillance to rapid vaccines. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Akari, Astrazeneca, Athersys, Azurrx, BMS, Calcimedica, Eiger, Flexion, Ipsen, Kubota, Lilly, Merck, Novartis, Synairgen, TG. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADC, Agex, Aradigm, Bixink, Coimmune, Enzychem, Evergreen, Formula, Gilead, Inovio, Lixte, Lonza, Moderna, Oxford Biodynamics, Puma, Teva, Vivus, Xbiotech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Alexion, BMS, Essa, Galectin, Genmab, Novan, Novartis, Pierre Fabre, PTC, Sosei, Telix, Vertex. Read More
Despite a global pandemic that is wreaking havoc on the overall economy, biopharma financings and grants during the month of April have shown solid numbers. Read More
