In biotech and biopharma’s third-largest ever up-front development and commercialization deal, Crispr Therapeutics AG will receive an initial $900 million in an amended deal with Vertex Pharmaceuticals Inc. to lead the development, manufacturing and commercialization of gene editing therapy CTX-001 for sickle cell disease and transfusion-dependent beta-thalassemia. Read More
LONDON – The EMA’s safety committee has concluded that unusual blood clots with low blood platelets are a rare side effect of Johnson & Johnson Inc.’s COVID-19 vaccine and that a warning should be added to the label. The decision is based on all available evidence, which currently consists of eight reports from the U.S. of serious cases of thrombosis, one of which was fatal. All cases were in people under 60 years of age, and within three weeks after vaccination, the majority in women. One case occurred during the clinical trials. Read More
Adverse events and criteria for determining remission in an otherwise positive early study by Syndax Pharmaceuticals Inc. with oral menin inhibitor SNDX-5613 apparently gave Wall Street pause, and shares (NASDAQ:SNDX) closed at $13.42, down $5.96, or 31%. Read More
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients. Read More
DUBLIN – In keeping with the record-breaking year for biotech fundraising across the globe, the Swiss biotech sector also scaled new heights in 2020, with aggregate investment of CHF3.4 billion (US$3.7 billion), according to the newly published Swiss Biotech Report 2021. It represents almost a threefold increase on the CHF1.2 billion total it logged in 2019. Read More
Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago. Read More
OS Therapies LLC, the developer of a listeria-based cancer vaccine to prevent metastasis and increase overall survival in young people with osteosarcoma, has closed on a $6 million series A financing led by Noble Capital Markets and Tichenor Ventures. The funds will help the company advance its lead candidate, OST-HER2, into a phase IIb trial this year with hopes of a potential FDA filing by in 2022. Read More
HONG KONG – Laboring under the burden of a new wave of COVID-19 infections that have raised its case total to 15.3 million, second only to the U.S., India is ramping up its vaccination efforts by opening up COVID-19 vaccine availability to citizens 18 years or older from May 1, according to the Ministry of Health and Family Welfare. However, ensuring a steady vaccine supply for the world's second most populous country, with nearly 1.4 billion people, might prove to be an issue. So far, India has administered just over 124 million COVID-19 vaccine doses. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Enhertu gets first nod in Europe; At-home COVID-19 remedies sought; Fed Circuit: Appeal based on misreading of court’s decision; Russia expands access to certain pediatric treatments. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Alnylam, Bioarctic, Eisai, Eli Lilly, Incyte, Ionis, Janssen, Jazz, Leading, Medincell, Morphosys, Ripple, Siteone, Sorrento, Steba, Syndax, T3D. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Argenx, Bluebird, Can-Fite, Cannabics, D&D, Elektrofi, Gain, Gamut, Hoth, Immunomic, Lamassu, Lineage, Oncotelic, Resverlogix, Seqirus, Sparingvision, Zentalis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Autolus, Cyclo, Erytech, GW, J&J, Kalvista, Lexeo, Pharmather, Seelos, Transcenta, Vincerx, Y-mabs. Read More
