Amesh Adalja, of the University of Pittsburgh School of Medicine, told BioWorld Today that, although too early to tell for sure about toxicity, it’s “an encouraging sign” that Nabriva Therapeutics AG has chosen to develop lefamulin, a new antibiotic in the mushroom-derived pleuromutilin class that has shown a clean profile in phase II trials against skin infections. Read More
Too many U.S. patent examiners aren’t “getting the memo” on how to apply recent court rulings on laws of nature and abstract ideas to patent applications covering drugs and diagnostics to software and financial management tools. Read More
DUBLIN – The EMA launched a formal consultation process Tuesday on the development of a new guideline for first-in-human and early stage clinical trials of investigational drugs. Read More
HONG KONG – Biotech companies worldwide are gearing up to expand into the China market even as the CFDA toughens up its health care market through a series of reforms. Read More
LONDON – Big data has the power to change the way drugs are accessed, used and regulated, but there are barriers to its implementation – in complying with data protection legislation, engendering trust, understanding the strengths and limitations of datasets and developing analytical methods to reach conclusions that can be transferred through to regulatory decisions. Read More
Pharmaxis Ltd., of Sydney, reported that the National Health and Medical Research Council has awarded it a research grant of A$421,545 (US$318,560) for development and testing of its Orbital Inhaler with a dry powder formulation of the antibiotic tobramycin for the treatment of cystic fibrosis. The company will work with the Sydney-based Woolcock Institute of Medical Research. Read More
Amarin Corp. plc, of Dublin, reported data that further characterized the efficacy and safety of Vascepa (icosapent ethyl) in statin-treated women with persistent high triglyceride levels. Read More
Acadia Pharmaceuticals Inc., of San Diego, started ADVANCE, a phase II study to evaluate pimavanserin for adjunctive treatment in patients with negative symptoms of schizophrenia. Studies show that about 40 to 50 percent of schizophrenia patients suffer from prominent negative symptoms. Read More
Morphosys AG, of Martinsried, Germany, said licensee Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, presented results from a phase IIa study testing guselkumab, a fully human anti-IL-23 monoclonal antibody, in the treatment of active psoriatic arthritis. Data showed a substantially higher percentage of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of the disease, or ACR20, at week 24, the study’s primary endpoint, compared with patients receiving placebo. Results also showed statistically significant improvements in all secondary endpoints, including physical function, psoriatic skin lesions and other health-related outcomes in patients treated with guselkumab compared with patients receiving placebo. Read More
Arbutus Biopharma Corp., of Vancouver, British Columbia, presented preclinical results showing that capsid inhibitor AB-423 has a dual mode of action for treating hepatitis B virus (HBV), by inhibiting HBV DNA and cccDNA synthesis. Read More
A U.S. federal jury in San Francisco found Sasan Sabdaran, the former director of drug safety risk management at Brisbane, Calif.-based Intermune Inc., and his friend Farhang Afsarpour liable for insider trading. Read More
