Antibiotic resistance is a natural phenomenon. Acquired resistance rapidly develops because of interspecies gene transmission and selective evolutionary pressure driven by high rates of antibiotic use in hospitals, the community and the agricultural industry. Read More
In the justified worries about drug resistance, it tends to get somewhat lost that there is, as yet, no completely untreatable superbug. The colistin resistance gene mcr-1 that was detected on plasmids in China and Europe in 2015, and in the US in 2016, has not yet met up with a bacterium that is resistant to all other drugs. Read More
Allergan plc, of Dublin, presented new data highlighting the in vitro activity of Avycaz (ceftazidime and avibactam) against several species of gram-negative pathogens, including certain strains of Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae and Pseudomonas aeruginosa. Read More
Glaxosmithkline plc, of London, and Innoviva Inc., of South San Francisco, reported top-line results from the pivotal phase III FULFIL study of once-daily, triple-combination therapy (fluticasone furoate/umeclidinium/vilanterol, or FF/UMEC/VI) comprising an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta agonist, in patients with chronic obstructive pulmonary disease. Read More
Adaptimmune Therapeutics plc, of Oxford, U.K., said the EMA Committee for Orphan Medicinal Products has adopted a positive opinion recommending their T-cell therapy targeting NY-ESO for designation as an orphan medicinal product for the treatment of soft tissue sarcoma. Read More
As its genesis so potently illustrates, the rise of antimicrobial resistance (AMR) will not be defused by an antibiotics arms race against the superbug. Read More
According to the old adage, "Where there's muck, there's brass." And this may prove to be the case for a group of researchers at Northeastern University in Boston, led by Kim Lewis. Their work over the past 18 months has captured media attention following their use of an electronic isolation chip (Ichip) to grow bacteria from soil and then identify and harvest antibiotic compounds contained therein. Read More
Long-awaited data from a confirmatory phase III study aimed at convincing regulators of the efficacy of twice-rejected Kiacta (eprodisate) in AA amyloidosis, ended up dealing a crushing blow to Bellus Health Inc., with top-line results Monday showing the five-year, event-driven trial missed the primary endpoint of slowing renal function decline in patients with the orphan disease. Read More
DUBLIN – Biotech investors shrugged off short-term fears about any potential fallout from Thursday's looming vote on Britain's continued membership of the EU, pumping more than $125 million into two U.K. firms, Verona Pharma plc and F2G Ltd., which will enable them to move their respective drug candidates into a phase IIb trial in chronic obstructive pulmonary disease (COPD) and a registration study in invasive aspergillosis. Read More
Since the mcr-1 gene was found in people and pigs in China last year and then last month the first U.S. case of a patient with an infection resistant to a last-resort antibiotic was reported, tensions are mounting. Read More
LONDON – Circassia Pharmaceutical plc's lead immunotherapy program has flopped in a phase III 1,200 -subject trial in cat allergy, sending the shares of the UK's most valuable biotech crashing down by 66 percent. Read More
Savara Pharmaceuticals Inc. CEO Rob Neville told BioWorld Today the all-stock buyout of Serendex Pharmaceuticals A/S brings aboard a pair of orphan products, one of them "already enrolling phase II/III" trials in Europe and Japan for pulmonary alveolar proteinosis (PAP). "Being able to pull off an acquisition of a company like Serendex for a private company like us was a big win," he said. Read More
With Monday's seal of approval from the U.S. Supreme Court, inter partes review (IPR) could be on its way to becoming the drug and device patent challenge of choice. Read More
