With an ongoing phase II trial showing that a pair of its SARS-CoV-2 neutralizing antibodies has so far reduced viral load, symptoms and COVID-19-related hospitalization and ER visits, Eli Lilly and Co. has asked the FDA to consider an emergency use authorization (EUA) for one of the components, LY-CoV555.
CAJICA, Colombia – Privately held Inosan Biopharma SA De Cv, of Mexico City, is racing to develop a biological treatment to cure COVID-19 patients. Inosan has mastered the technique of using horses to produce antibodies to heal patients bitten by poisonous creatures, such as snakes, spiders and scorpions.
San Diego-based Anaptysbio Inc.’s phase II blowup with anti-IL-33 monoclonal antibody etokimab in chronic rhinosinusitis with nasal polyps (CRwNP), disclosed Aug. 10, followed the compound’s mid-stage atopic dermatitis (AD) fizzle in November of last year, and raised questions not only about the lead candidate but also about the target.
The pace of biopharma mergers and acquisitions has quickened with Johnson & Johnson’s $6.5 billion all-cash acquisition of Momenta Pharmaceuticals Inc. Bringing Momenta into the fold strengthens the Janssen Pharmaceutical Companies of Johnson & Johnson’s immune-mediated disease portfolio and grows its interest in autoantibody-driven disease therapies.
HONG KONG – Looking to boost its R&D capacity, China’s Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. launched an IPO on July 22 that raised ¥1.7 billion (US$240 million) on Shanghai’s STAR market. Shares (SSE:688336) almost doubled in value on the first day of trading, closing at ¥54.10, for a gain of 92%.
The first bispecific antibody to win regulatory approval, Removab (catumaxomab) was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China’s NMPA, investigating the trifunctional bispecific antibody in patients with peritoneal carcinomatosis, a form of advanced gastric cancer.
NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I.
LONDON – From the start of the pandemic antibodies have been the main focus of attempts to understand the immune response to SARS-CoV-2 and ascertain what it will take for vaccines to be protective.
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year. "We expect the trial to start in U.S. in the [middle of] next year. We will then expand the trial to China afterwards as planned," Joan Shen, CEO of I-Mab, told BioWorld.
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