Second Genome Inc. (SG) CEO Karim Dabbagh said his firm’s deal with Gilead Sciences Inc. is “pretty significant, given some of the other deals in the microbiome and inflammatory bowel disease [IBD] space,” telling BioWorld the potential $1.5 billion-plus agreement involves “biomarkers in multiple disease areas on five of Gilead’s portfolio programs in inflammation, fibrosis and oncology. Associated with that is a drug discovery collaboration around five targets in the context of IBD.” Read More
DUBLIN – Immunomedics Inc. is stopping the phase III Ascent trial of its antibody-drug conjugate, sacituzumab govitecan, in triple-negative breast cancer (TNBC) on the unanimous recommendation of the study’s independent data safety monitoring committee, after a scheduled look at the study data uncovered what the company called “compelling efficacy.” Read More
Although public offerings slowed considerably in March as a result of the steepest stock market declines in history during that period, global biopharmaceutical companies managed to collectively generate just over $16 billion in the first quarter from a record number public and private transactions. Only the first quarter of 2018 saw more cash raised in the past decade, according to BioWorld data. Read More
Shares of Millendo Therapeutics Inc. (NASDAQ:MLND) fell 70.1% to $1.45 on April 6 after a pivotal study of its experimental Prader-Willi syndrome (PWS) therapy, livoletide, failed to show a statistically significant improvement in hyperphagia, or insatiable hunger, and food-related behaviors vs. placebo. Read More
LONDON – Izana Bioscience Ltd. has become the third company to supply an anti-GM-CSF antibody for compassionate use against COVID-19, announcing namilumab, currently in phase IIb testing in the treatment of rheumatoid arthritis and ankylosing spondylitis, will be used to treat 20 patients with severe respiratory symptoms. Read More
Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules. Read More
With positive top-line data reported for Axsome Therapeutics Inc.’s oral migraine candidate, AXS-07, in its INTERCEPT trial, the company and the candidate have notched two successful phase III trials in little more than three months. Read More
HONG KONG – Another promising candidate has emerged in the race to find a treatment for the COVID-19 coronavirus. San Diego-based Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection. Read More
NEW DELHI - In a bid to limit what is seen as excessive dependence on active pharmaceutical ingredients (APIs) from China, the Indian government has announced a $394 million scheme to promote the development of three bulk drug parks. Read More
LONDON – Amphista Ltd. becomes the latest to join the growing band of proteolysis targeting chimera (Protac) specialists, arriving on the scene with a $7.5 million series A and what it says is a new approach to targeted protein degradation (TPD). Read More
New hires and promotions in the biopharma industry, including: Allovir, Apellis, Constellation, Egenesis, Emergent, Gritstone, Immunomedics, Obseva, Polarityte, Rafarma, Seres. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeterna Zentaris, American Brivision, Auris, Axsome, Bryn Pharma, Catalyst, Compugen, Cytodyn, Immunomedics, Incyte, Inovio, Janssen, Menlo, Millendo, Oxthera, Sun Biopharma, Windtree, Yiviva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, BMS, Daiichi, Eisai, GW, Histogen, Hope, Mallinckrodt, Mateon, Mesoblast, Novo Nordisk, Takeda, Tetra, Tracon. Read More
