DUBLIN – Shares in Santhera Pharmaceuticals Holding AG dropped as much as 33 percent Wednesday on news that it expected its appeal against a negative opinion on the European approval of its Duchenne muscular dystrophy (DMD) drug Raxone (idebenone) to be unsuccessful. Read More
Concerns over the clinical relevance and risk-worthiness of Puma Biotechnology Inc.'s Nerlynx (neratinib) in extended adjuvant use for women with early stage, HER2-positive breast cancer made it unlikely that the Europe's Committee for Medicinal Products for Human Use (CHMP) would support a marketing authorization application for the drug without "additional steps," Puma said. Read More
LONDON – The first independent analysis of what the industry is doing to address the threat of antimicrobial resistance (AMR) ranks Glaxosmithkline plc and Johnson & Johnson as first among pharma companies and Astrazeneca plc spinout Entasis Therapeutics Inc. as leader of the biotech pack. Read More
Janssen Biotech Inc. can't get a do-over on how a patent was issued just so it can bring the claims into a harbor safe from double-patenting challenges, the U.S. Court of Appeals for the Federal Circuit ruled Tuesday. Read More
HONG KONG – Taiwan Liposome Co. Ltd. (TLC) has established a joint venture (JV) with China's Jixi Biotechnology Partners dedicated to clinical trials, registration and commercialization of its products in mainland China. Read More
The FDA cleared Apexian Pharmaceuticals Inc.'s IND for oncology candidate APX-3330 in three days, CEO Steve Carchedi told BioWorld, "which is probably a world record. It was, at that time, the most widely used unapproved drug," with safety data in no fewer than 422 patients already available. Read More
Ultragenyx Pharmaceutical Inc., of Novato, Calif., priced its underwritten public offering of about 4.3 million shares of its common stock at $57 each, for gross proceeds of $250 million. Read More
Immuron Ltd., of Melbourne, Australia, said it will receive a cash refund of about A$2.2 million (US$1.7 million) for eligible 2017 R&D expenses under the Australian government's R&D income tax concession incentive program. Read More
Cynata Therapeutics Ltd., of Melbourne, Australia, said the first patient in cohort B was treated with CYP-001, its first mesenchymal stem cell product for steroid-resistant acute graft-vs.-host disease. Read More
Disarm Therapeutics Inc., of Cambridge, Mass., named Thomas Engber senior vice president and head of neuropharmacology and translational sciences. Read More
The U.S. Senate voted 55-43 Wednesday to make Alex Azar the next Health and Human Services (HHS) secretary. Seven Democrats joined Republicans in confirming the former Eli Lilly USA executive. While industry groups such as the Biotechnology Innovation Organization, Medical Device Manufacturers Association and Advanced Medical Technology Association were quick to congratulate Azar's confirmation, other groups were not happy about it. Read More
