BioSpace News Archive

As the holidays roll into November and December many companies go quietly into the New Year, eschewing news releases or large scale investor communication.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults

Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, today announced that its chief executive officer, Dr. Amit Kumar, will present at the Biotech Showcase 2020 conference being held January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California.

Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery.

Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines, today announced the appointment of Christina Coughlin, M.D., Ph.D., as the Company’s chief medical officer, effective January 6, 2020.

Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage biopharmaceutical company, today announced the submission of a 505(b)(2) New Drug Application (“NDA”) for Qtrypta™ to the U.S. Food and Drug Administration (“FDA”) for the acute treatment of migraine.

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) approved DAYVIGO™ (lemborexant) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Daniel O’Day, Gilead’s Chairman and Chief Executive Officer, will provide an overview of the company at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 13 at 9:30 a.m. Pacific Time.

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the initiation of PHALCON-HP.

Akari Therapeutics, Plc (Nasdaq:AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces that a U.S. Food and Drug Administration (FDA) investigational new drug application (IND) is open for its multicenter Phase III study for the treatment of pediatric HSCT-TMA with nomacopan,