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Friday, June 2, 2017

Endocyte stakes future on smaller pipeline, focus on ‘promising programs’
Although halting one clinical program, modifying another and axing 40 percent of its staff wasn’t exactly the way Endocyte Inc. hoped to make its entrance at the American Society of Clinical Oncology annual meeting in Chicago, those are precisely the steps the company took to “put patients first,” according to CEO Mike Sherman. The company’s reduction in force and termination of programs for EC-1456 and EC-1169 in taxane-naïve patients ultimately affect the company’s capacity to execute, but not its capabilities, Sherman said. The news drove stock shares (NASDAQ:ECYT) down 33 percent by midday to $1.84.

ASM Microbe: Antibiotics shortage requires disaster management tactics
NEW ORLEANS – Drug shortages, a persistent thorn in the side of health care providers across the spectrum, have moved from troubling to hazardous, speakers said today at the American Society for Microbiology’s (ASM) Microbe 2017 meeting. Though the FDA looks at the situation in terms of supply and demand, “I think of managing a drug shortage almost like managing a disaster,” Milena McLaughlin, an assistant professor of pharmacy practice at Midwestern University, told attendees during a session on dealing with the challenge.

Chinabio Partnering 2017: Drugmakers optimistic about China’s proposed regulatory reforms
ZHUHAI, China – Attendees at what has become one of Asia’s most important annual partnering meetings heard multinational company and local biopharma execs talk optimistically about positive changes the CFDA proposed just weeks ago, which promise to open the doors to China’s market for novel drugs. Calling the reforms a “sea change” in China’s regulatory environment, Greg Scott, founder and chairman of Chinabio Group said that change is happening more quickly than people expect and predicted it will take only two to three years for the draft reforms to stabilize and then accelerate. The depth and breadth of the reforms are still being digested by companies here trying to understand what the impact will be on their businesses. But one thing is clear: The reforms are designed to bring better drugs to Chinese patients faster.

First European crowdfunding platform for life sciences goes live in U.K.
LONDON – Europe’s only crowdfunding platform dedicated to the life sciences has gone live in the U.K., with four companies now looking to attract investors online, and four more gearing up to launch campaigns. Capital Cell has set up in Cambridge two years after its formation in Spain, where to date €4.4 million (US$4.6 million) has been raised via the platform by 14 companies.

Colombia will implement new guidelines for regulation of biosimilars
BUENOS AIRES, Argentina – In Colombia, guidelines for biosimilar regulation share a certain similarity with buses: wait for ages, then two come along at once. In August, three years after the Colombian government issued a decree mandating the ministry of health to establish regulations for biosimilars, two new guidelines – focusing on stability and immunogenicity – will be implemented. Hector Castro, director for medication and technology at the Ministry of Health and Social Protection, told BioWorld Today, “We are working on producing risk management plans, guidance for biosimilars.” They follow on the heels of a third for good manufacturing practice, which was published in December 2016. Both importers and producers will now be able to start operations under these new guidelines.

Plus, news from ASCO 2017
See Monday’s edition for top reports from the American Society of Clinical Oncology annual meeting in Chicago. Sessions kick off this afternoon.

Also in the news
Aslan, Astrazeneca, BMS, Flex, Janssen, Lion, Merck, Mersana, Merus Labs, Motif Bio, Nexvet, Novadigm, Novartis, Orexo, Reata, Savara, Seattle Genetics, Supreme Pharma, Trillium, Windtree

Coming Monday in BioWorld Insight

Precision medicine playing a role in bladder cancer treatment
Treatment outcomes for various cancer indications certainly benefit from both early detection and the selection of the most appropriate targeted therapeutics, which are often guided in their use by companion diagnostic tests. In the second part of our series on bladder cancer, we review how the new evolving ecosystem of precision medicine is playing a significant role in the research and development of new treatments for this condition as well as look at some of promising new research in the area.

Rheumatoid arthritis market congested; price war brewing?
The rheumatoid arthritis market has come a long way since Enbrel (etanercept, Amgen Inc.) was first approved to treat the disease in 1998. Nearly two decades later, there are a handful of additional TNF-alpha inhibitors and multiple other drugs working through different mechanisms of action that have been approved by the FDA to treat rheumatoid arthritis. The newest drug, Kevzara (sarilumab), an IL-6 inhibitor co-developed by Regeneron Pharmaceuticals Inc. and Sanofi SA, is being launched at a wholesale acquisition cost (WAC) of $39,000 per year, an approximately 30 percent discount to the leading TNF-alpha inhibitors in the space and a 16 percent discount to Actemra (tocilizumab, Roche Group), the other FDA-approved IL-6 inhibitor.