Kalvista Pharmaceuticals Inc.’s chief development officer, Christopher Yea, said the across-the-board positive phase II top-line data with KVD-900 for on-demand use against hereditary angioedema (HAE) attacks will open “a very flexible discussion with regulators” regarding the design and endpoints of the phase III study to come with the oral kallikrein inhibitor. Shares of the Cambridge, Mass.-based firm (NASDAQ:KALV) closed at $33.50, up $17.89, or 115%, after reaching a high of $45, as Wall Street digested the findings. Read More
New interim phase II data in advanced non-small-cell lung cancer (NSCLC) has shown that a combination of Heat Biologics Inc.'s cell therapy candidate, HS-110 (viagenpumatucel-L), and Bristol Myers Squibb Co.'s Opdivo (nivolumab) helped extend overall survival for both checkpoint inhibitor-naïve patients and those who had been treated with a checkpoint inhibitor but whose disease had later progressed. Read More
LONDON – The World Health Organization’s (WHO) mission to Wuhan has rejected accidental laboratory escape as the source of the SARS-CoV-2 pandemic, but failed to uncover satisfactory evidence of its exact origin. Read More
HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld. Read More
Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration or formulation, such as abuse-deterrent opioids. Read More
DUBLIN – After a COVID-19-induced delay that set it back most of last year, Interna Technologies BV has moved its first microRNA-based drug development program into the clinic and has also unveiled €18.5 million (US$22.4 million) in a series B funding round, which it completed in two stages. Read More
Janssen Pharmaceutica NV and Exelixis Inc. are among the many companies releasing new data ahead of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which runs Feb. 11-13. Read More
New hires and promotions in the biopharma industry, including: Antev, Aquestive, Caribou, Eli Lilly, Equillium, Gemini, Ironwood, Metrion, Novocure, Werewolf. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Astrazeneca, Bausch Health, Brainstorm Cell, BMS, China Oncology Focus, Edding, Immunomet, Navidea, RDIF, Sorrento, Triastek. Read More
