Qiagen said Wednesday it is seeking emergency FDA clearance for its coronavirus diagnostic. Separately, Gilead started a pair of Phase III trials of remdesivir to treat COVID-19, bringing the total number of trials testing the...

Initial signals from two ongoing trials in China of Gilead’s remdesivir to treat COVID-19 should be available in a few weeks, Marie-Paule Kieny said at a WHO press conference Wednesday. Assistant Director-General Kieny co-chaired the...

AstraZeneca ends CV outcomes trial of Epanova  AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...

FDA again reviewing Immunomedics’ ADC  FDA has accepted a resubmitted BLA from Immunomedics Inc. (NASDAQ:IMMU) seeking accelerated approval of sacituzumab govitecan to treat third-line metastatic triple-negative breast cancer. The company had received a complete response...

Cirius withdraws IPO  Cirius Therapeutics Inc. withdrew its IPO proposal on Dec. 20. The metabolic and liver disease company had filed in January to raise up to $86.3 million in a NASDAQ offering. In November,...

Qiagen confirms acquisition interest  Qiagen N.V. (NYSE:QGEN; Xetra:QIA) said Friday it is reviewing its strategic alternatives after receiving several “non-binding indications of interest for the acquisition” of the diagnostics company. Since acquisition rumors emerged Wednesday,...

Earnings on deck At least 27 profitable biotechs and pharmas are slated to report earnings this week. (A) During market hours in Europe, premarket on U.S. exchanges; (B) Fiscal 1Q Company Date Pre/post mkt 2Q19...

FDA approves Samsung's Humira biosimilar  Samsung Bioepis Co. Ltd. (Incheon, South Korea) said FDA approved Hadlima adalimumab-bwwd, a biosimilar of autoimmune drug Humira from AbbVie Inc. (NYSE:ABBV). Samsung's partner Merck & Co. Inc. (NYSE:MRK) will...

Earnings on deck At least 22 profitable biotechs and pharmas are slated to report earnings this week. (A) During trading hours in Europe; premarket on U.S. exchange; (B) Fiscal 4Q; Company Date Pre/post mkt 1Q19...

FDA granted Janssen's Balversa erdafitinib accelerated approval to treat bladder cancer, making it the first FGFR kinase inhibitor to gain U.S. approval. Balversa is indicated to treat adults with locally advanced or metastatic urothelial carcinoma...