BioSpace News Archive

Lannett Company, Inc. (NYSE: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg.

Sangamo Therapeutics, Inc. (Nasdaq: SGMO) announced today the completion of the transfer to Pfizer of the SB-525 Hemophilia A gene therapy Investigational New Drug application (IND). Pfizer is advancing SB-525 into a Phase 3 registrational clinical study in 2020 and has already commenced enrolling patients into a Phase 3 lead-in study.

FibroGen, Inc. (NASDAQ:FGEN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD patients.

An Emerging Markets News Commentary

Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the initiation of a proof-of-concept study for TRV734, the Company’s novel mu-opioid receptor selective agonist.

Microbot Medical Inc. (NASDAQ: MBOT) today announced the revealing of LIBERTYTM, the world’s first fully disposable robotic system for use in neurovascular, cardiovascular and peripheral vascular procedures

OpGen, Inc. (Nasdaq: OPGN) reported an update on the business of Curetis GmbH (“Curetis”), the other party to the planned business combination with OpGen.

Hoth Therapeutics, Inc. (Nasdaq: HOTH) (“HOTH” or the “Company”), a biopharmaceutical company focused on developing new generation therapies for dermatological and immunological disorders such as atopic dermatitis, psoriasis, asthma and acne, today issued its 2019 Shareholder Letter.

TG Therapeutics, Inc. (NASDAQ: TGTX), today announced it has entered into a definitive agreement to sell approximately 5.4 million shares of registered common stock of the Company at $9.20 per share, to a single, biotechnology-focused, institutional investor as a registered direct public offering.

Tauriga Sciences, Inc. (OTCQB: TAUG) (“Tauriga” or the “Company”), a revenue generating company that operates through the development, distribution, and licensing of proprietary products as well as the evaluation of potential acquisition opportunities and equity investments, today announced that it has been certified by the global retail giant, Walmart Inc. (“Walmart”), to become a Domestic Supplier (“Vendor”).