Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
HONG KONG – Galmed Pharmaceuticals Ltd. has signed a research and development collaboration agreement with fellow Israeli biotech company Mybiotics Pharma Ltd. to identify and optimize the selected microbiome repertoire associated with the response to Aramchol (arachidyl amido cholanoic acid), Galmed’s fatty acid bile acid conjugate treating nonalcoholic steatohepatitis.
LONDON – A second COVID-19 vaccine has reported positive results in an interim phase III analysis, with Russia’s Sputnik V showing 92% efficacy. The news comes two days after the first readout from a phase III COVID-19 vaccine trial reported 90% efficacy for Pfizer Inc. and Biontech SE’s BNT-162b2.
HONG KONG – Kira Pharmaceuticals is riding high after completing a $46 million fundraiser and appointing Frederick Beddingfield as CEO. “The $46 million comprises a series A of $18 million and a series B of $26 million, with investors Quan Capital, 6 Dimensions Capital, Qiming Venture Partners, and Sinopharm Capital participating in both rounds,” Beddingfield told BioWorld.
3D Medicines Inc. has licensed in from Aravive Inc. a phase Ib-completed GAS6/AXL inhibitor known as AVB-500 in a deal worth up to $219 million. The Chinese firm will have the rights to develop and commercialize the drug candidate across all oncology indications in mainland China, Hong Kong, Macau and Taiwan.
HONG KONG – Humanigen Inc. has executed its first licensing agreement in the Asia-Pacific region, in a deal worth up to $20 million that gives Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. the development and commercialization rights to lenzilumab for COVID-19 in South Korea and the Philippines.
HONG KONG – Pangyo, South Korea-based SK Biopharmaceuticals Co. Ltd. has agreed to collaborate with New York-based Lifesci Venture Partners to invest in private health care companies developing novel therapies and innovative technologies.
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.
Yantai, China-based biologics developer Remegen Ltd. launched the biggest pre-revenue biotech IPO in Hong Kong this year by raising HK$3.99 billion ($514.5 million) on Nov 9. With this IPO, Remegen’s CEO Jianmin Fang told BioWorld in an exclusive interview, the company aims to take its assets abroad.