Whether a product violates the Federal Food, Drug and Cosmetics Act (FDCA) is a call for the FDA to make, not drug and device companies, the U.S. Court of Appeals for the Federal Circuit reiterated Wednesday. Read More
The FDA has approved Sanofi Pasteur Ltd.'s Dengvaxia vaccine to prevent dengue disease for children ages 9 through 16 with a previous dengue infection and who live in endemic areas of the U.S., including the territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands. Read More
LONDON – Transgene SA has signed an exclusive licensing agreement with Astrazeneca plc around its next-generation "armed" oncolytic viruses, providing a validation of the technology and a welcome short-term cash infusion. Read More
DUBLIN – Try as they might, Genkyotex SA's management team found it impossible to shift investor perceptions that a phase II trial of GKT-831 in primary biliary cholangitis (PBC) was a bust. Read More
Exocrine pancreatic insufficiency (EPI) is one of the potential dreaded accompaniments of cystic fibrosis (CF) that patients must deal with, a condition that means downing as many as 40 pills per day if they take porcine-derived pancreatic enzymes (PPEs), the standard of care. Read More
Combioxin SA, a Geneva-based startup developing a non-antibiotic drug to trap and neutralize bacterial toxins, has successfully shown initial safety and efficacy for the therapy, CAL-02, in a phase I study of patients with severe community-acquired pneumococcal pneumonia taking the experimental therapy along with an antibiotic. Read More
Exelixis Inc., of Alameda, Calif., reported total revenues for the quarter ended March 31 of $215.5 million, compared to $213.7 million for the comparable period in 2018. Net product revenues were $179.6 million for the quarter compared to $134.3 million in Q1 2018. Read More
Magenta Therapeutics Inc., of Cambridge, Mass., priced its public offering of about 4.2 million shares of common stock at $13.25 each, for gross proceeds of about $56.3 million. Read More
Bristol-Myers Squibb Co., of New York, received the requisite number of consents to adopt the proposed amendments with respect to all outstanding notes of Celgene Corp., of Summit, N.J. The settlement of the early tenders will occur on or about the closing date of Bristol-Myers Squibb's acquisition of Celgene. (See BioWorld, Jan. 8, 2019.) Read More
