Florida's Catalyst Pharmaceuticals Inc. is suing the FDA to overturn approval of a competitor's drug for the rare autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS), alleging the green light – arriving just months after its own approval – was "arbitrary, capricious" and violated the company's rights to market exclusivity for the medicine. Read More
DUBLIN – ADC Therapeutics SA added $76 million in a belated extension to its series E round, taking the total raise to $276 million. The initial close of $200 million was back in October 2017, but progress with its two lead antibody-drug conjugates (ADCs) prompted the latest injection of cash. Read More
Prelude Therapeutics Inc. founder and CEO Kris Vaddi said the new $60 million in series B money – which brings to $95 million the amount raised since the firm's inception in 2016 – should pull the current phase I research through proof-of-concept stage, targeting protein arginine methyltransferase 5 (PRMT5) in cancer. Read More
Swedish Orphan Biovitrum AB (Sobi) shed some old skin to grow some new by expanding its Novimmune SA deal by acquiring emapalumab (NI-0501, branded as Gamifant) and all its related assets. Sobi also gets all emapalumab employees involved in the drug's clinical and biopharmaceutical development. Read More
The World Health Assembly, a decision-making body of the World Health Organization (WHO), included a chapter on Chinese traditional medicine in the latest version of its influential global compendium for the first time in history. Read More
Florida Gov. Ron DeSantis Tuesday signed into law a bill establishing two prescription drug importation programs that will allow the import of FDA-approved drugs from Canada and other countries. Read More
Innate Pharma SA, of Marseille, France, said it plans to conduct a registered public offering of American depositary shares (ADSs) in the U.S. and has confidentially submitted a form F-1 statement to the SEC. Read More
Sorrento Therapeutics Inc., of San Diego, said it is exploring the possibility of an IPO of its majority-owned subsidiary, Scilex Holding Co. Read More