LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection. Read More
The world has been running an ultramarathon since the COVID-19 pandemic began, but despite the ups and downs of cases and deaths, the wins and losses of clinical efforts, every day is another step forward toward herd immunity and the finish line. Read More
Just weeks after announcing plans to invest billions in an mRNA therapeutics research center, Sanofi SA has acquired Translate Bio Inc. for $3.2 billion, building on a development partnership focused around the technology.
Instead of waiting for Congress to come up with a solution to reduce drug prices, a trio of U.S. lawmakers told the U.S. Department of Health and Human Services (HHS) it needs to tackle drug prices with the tools it already has – compulsory licensing and march-in rights. Read More
Because a safety threshold was exceeded in its study of the company’s lead candidate, otenaproxesul, Antibe Therapeutics Inc. said it has placed testing of the anti-inflammatory drug on a required pause. Read More
Outlook Therapeutics Inc. CEO Russell Trenary said positive results from the phase III study called Norse Two represent “the final step we need” to proceed with the BLA in the first quarter of next year for an ophthalmic formulation of the VEGF binder bevacizumab to treat wet age-related macular degeneration (AMD). Read More
Despite prior marketing approvals in Europe and Canada, an effort to win FDA support for the bifunctional alkylating agent treosulfan has drawn a complete response letter (CRL) from the agency, the company's U.S. rights holder, Medexus Pharmaceuticals Inc., said. Read More
Jiangsu Gdk Biotechnology Co. Ltd. will further develop its vaccine pipeline after it started trading on the Shanghai Stock Exchange Star Market on Aug. 2, where it raised ¥1.21 billion ($187 million) through an initial public offering of 22 million shares. The company plans to use the proceeds from the listing to establish a manufacturing plant to produce its quadrivalent influenza vaccine and invest in R&D for other vaccine candidates, as well as replenish working capital and repay bank loans. Read More
Statements Cytodyn Inc. made about the potential for its investigational monoclonal antibody, leronlimab, to treat COVID-19 continue to reverberate with U.S. authorities. Read More
New hires and promotions in the biopharma industry, including: Arcutis, Cellino, Cerebral, Clearmind, Gennao, Ginkgo, Ironwood, Lumos, Meissa, Oyster Point, Pieris, Q32, Reform, Scholar Rock, Somalogic, Synox. Read More
Biopharmas raising money in public or private financings, including: ABVC, Avidity, Cybin, DSS, Engrail, Icosavax, Inventiva, Nuvalent, Pharmacyte, Rallybio and Vivacitas. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Biogen, Biophytis, Cytokinetics, Flugen, Humanigen, Ionis, Moderna, Novartis, Prometheus, Servier, Zentalis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Ancilia, Burning, China Grand Pharmaceutical, Etherna, GT, Impact, Innocan, Insilico, Sanotize, Takeda, Westlake. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Amicus, Antengene, Arcturus, Astrazeneca, Autobahn, Avidity, Canbridge, Epygenix, Galmed, Hummingbird, Iaso, Mustang, Protalix, Regeneron, Shenzhen Kangtai Biological, Sorrento, Vaxart. Read More
