In the quest for regulatory approval for their COVID-19 vaccine, Sanofi SA and Glaxosmithkline plc (GSK) said they plan to submit their phase III and booster efficacy study data showing it induced a significant increase in neutralizing antibodies after a primary series of mRNA or adenovirus vaccines. Read More
Kodiak Sciences Inc. shares (NASDAQ:KOD) closed at $9.86, down $40.49, or 80.42% after the firm unveiled top-line data from its randomized, double-masked, active comparator-controlled phase IIb/III trial testing KSI-301, an antibody biopolymer conjugate, in treatment-naïve subjects with wet age-related macular degeneration (AMD). Read More
Lepu Biopharma Co. Ltd. started trading on the Hong Kong stock exchange on Wednesday, raising HK$904 million ($115.9 million) in an initial public offering. Trading opened at HK$7.13 per share and slid to HK$6.70 by midday before closing at HK$7.13. Read More
LONDON – The team that opened up the market for anti-vascular endothelial growth factor (VEGF) drugs in the treatment of eye diseases has formed a new company, Eyebio Ltd., with the aim of developing a new generation of ocular therapies. David Guyer and Anthony Adamis, founders of Eyetech Pharmaceuticals Inc., which brought Macugen (pegaptanib sodium) through to FDA approval in December 2004, set up Eyebio in August last year, with seed funding from SV Health Investors. Read More
PERTH, Australia – Prota Therapeutics Ltd.’s lead candidate PRT-120 induced clinical remission of peanut allergy in 51% of children in a phase IIb clinical trial. There are currently no curative therapies to treat food allergies, Prota Therapeutics CEO Mimi Tang told BioWorld. Peanut allergy in children can be particularly problematic because the only treatment is avoidance. Read More
U.K. biotech Complement Therapeutics Ltd has come out of stealth mode with €5 million ($5.7 million) in seed funding to tackle complement-related diseases, initially targeting the currently untreatable condition geographic atrophy due to dry age-related macular degeneration. Read More
The U.S. SEC reported a settlement Feb. 23 with Baxter International Inc. and its former treasurer, Scott Bohaboy, and former assistant treasurer, Jeffrey Schaible, resolving charges involving years of improper intra-company foreign exchange transactions that resulted in the misstatement of Baxter’s net income. Read More
On the success of last year’s establishment of a global mRNA vaccine technology transfer hub in South Africa, the World Health Organization (WHO) announced its next step Feb. 23: the creation of a global biomanufacturing training hub in South Korea that will serve low- and middle-income countries wanting to produce biologics, such as vaccines, insulin, monoclonal antibodies and cancer treatments. Read More
A sense of normalcy is returning to the U.K., at least from a regulatory perspective. The U.K.’s Medicines and Healthcare Products Regulatory Agency will continue to support COVID-19 clinical trials with ongoing regulatory and scientific input, but all further applications and meeting requests for COVID-19 products will be considered according to usual timelines rather than on an emergency basis, the agency said Feb. 23. Read More
The CDC’s Advisory Committee on Immunization Practices (ACIP) always had a full schedule, but COVID-19 amped it up. William Schaffner, who joined ACIP in 1982, talks with BioWorld's Lee Landenberger about the committee and how it makes the big decisions that affect public health policy. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ariana, Atma Journey, Aulos, Cyclerion, Filament, Foresee, Jnana, Synaptogenix, Trpharm and Vicore. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Pharma, AB Science, Abbvie, Armata, Bharat Biotech, Beigene, Cansino, Homology, Ocugen, Provention, RDIF. Read More
