How to assure screening for patients in whom just-approved Vitrakvi (larotrectinib) most likely will help is something "we've been working very hard for the last nine months" to establish, Joseph Germino, vice president of medical affairs for oncology with Bayer AG, told BioWorld. "The drug is so effective – it doesn't work in everybody [but] it works in most people – that it would be a shame if somebody were not able to get it because nobody checked" for eligibility. Read More
Beigene Ltd. clearly liked what it saw in the bispecific antibody platform being developed by Zymeworks Inc. The Beijing-based company is hooking up with Zymeworks in a pair of deals that could end up grossing Zymeworks more than $1 billion. Read More
A phase III trial testing a combination of Bristol-Myers Squibb Co.'s Opdivo (nivolumab) and Yervoy (ipilimumab) as maintenance therapy in some patients with extensive-stage small-cell lung cancer (SCLC) found it failed to improve overall survival vs. placebo. Results of the study, called Checkmate-451, together with Opdivo's recent failure to beat chemotherapy's OS benefit in relapsed SCLC during the confirmatory Checkmate-331 trial could put its accelerated approval in SCLC in jeopardy, Evercore ISI analyst Umer Raffat said. Read More
DUBLIN – Wuxi Nextcode is making Dublin a key hub in its strategy to build out its population genomics research platform by taking over Genomics Medicine Ireland Ltd. and embarking on a potential $400 million investment program, $225 million of which is committed up front. Read More
HONG KONG – The lack of cross-border regulations and coordination on genetic editing in general – and gene editing on embryos specifically – has emerged a key concern for industry leaders and regulators and a timely topic at the Second International Summit on Human Genome Editing in Hong Kong on Tuesday. Read More
LONDON – The National Health Service (NHS) in England is cutting £300 million (US$383 million) off its £400 million annual bill for Humira (adalimumab) after pitting biosimilar manufacturers against each other in a national procurement process. Read More
BRISBANE, Australia – A "world-first" clinical trial of a new immunotherapy to treat multiple sclerosis (MS) showed improved symptoms and improvement in the quality of life for the majority of patients. Read More
HONG KONG – Clinical-stage biopharma Taiwanj Pharmaceuticals Co. Ltd. said its drug candidate, JKB-122, for treating nonalcoholic fatty liver disease (NAFLD) showed positive results in a 12-week phase II study in Taiwan. Encouraged by those positive results, the company already has plans to push the compound to the next clinical stage in its homeland, with an IND expected to be filed in the second quarter of next year. Read More
Vedanta Biosciences Inc., of Cambridge, Mass., will receive $12 million from Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, triggered by the start of a phase I trial of VE-202, under the firms' ongoing collaboration. Read More
Engitix Ltd., of London, closed a £5 million (US$6.4 million) series A financing, led by a private investor. The company, spun out of the Institute for Liver and Digestive Health at University College London in 2016, is working to develop a pipeline of candidate drugs targeting liver fibrosis and liver and pancreatic cancers. Read More
