BioPharma, Diagnostics

Four intriguing biopharma developments this week

Here's a look at some of the most intriguing biopharma news developments this week from an investment in a new approach for early diagnosis of Alzheimer's disease to reports highlighting flaws in the FDA's accelerated drug and device approval programs. 

Even in the dog days of summer, it was hardly a dull week in the world of biopharma. Amidst the fallout from President Trump’s comments during and following the white supremacist rally in Charlottesville spurred an exodus from his manufacturing council starting with Merck’s CEO Kenneth Frazier and eventually Johnson and Johnson CEO and Chairman Alex Gorsky. But there was some exciting biotech and genetic testing investment news, a research collaboration for pediatric cancer and some damning reports on accelerated drug and device approvals by the FDA.

Fresh from the expansion of its genetic testing armory into cardiovascular diseases, Color Genomics raised $52 million as part of a larger ($80 million, that is) Series C round, TechCrunch reported.

Alzeca Biosciences in Houston closed an $11 million Series A round to advance an imaging technology for early diagnosis of Alzheimer’s disease it regards as a cheaper alternative to PET scans. Nanoparticles bind to amyloid plaque in the brain and release a dye that can be spotted with an MRI to provide for the early diagnosis of Alzheimer’s disease. The funding is intended to support pre clinical and Phase 1 clinical trials. The Werth Group led the round with participation from Dolby Family Investors and others, according to Xconomy. The funding round was led by Led by CEO Carlo Medici, the Houston company….also seeks to treat neurodegenerative disorders.

The U.S. Food and Drug Administration’s accelerated drug and device approval process came under fire in a couple of studies published by the Journal of American Medical Association. Dr. Huseyin Naci from the London School of Economics and Political Science, the author of one of the studies, explained in an email to Reuters that he and other researchers found that drugs approved through the accelerated approval program “are rarely subject to tests even in the post-approval period that use established and clinically meaningful outcomes.”  A report on devices concluded that few studies were randomized or blinded, making it tough to assess whether the device was better than another treatment.

The big data analysis trend is taking collaboration between research hospitals in some interesting directions. The latest example of this is an initiative for pediatric cancer research and other conditions led by Children’s Hospital of Philadelphia. The pediatric data resource center as part of a research initiative involving several institutions in Canada and the U.S., backed by the National Institutes of Health according to a news release. They include the Ontario Institute for Cancer Research, the University of ChicagoChildren’s National Health System, the Oregon Health and Science University and a technology company that specializes in these kinds of biopharma collaborations, Seven Bridges.

The collaboration will produce a centralized database and discovery portal of curated clinical and genetic sequence data from dozens of childhood cancer and structural birth defects cohorts, comprising thousands of patients and their families. Here is a snapshot of how it will function, from the news release.

The Kids First Data Resource Center will allow researchers to instantly search large genomic datasets using new data visualization tools and cloud-based data-sharing platforms. Researchers will be able to identify genetic pathways that underlie and may possibly link childhood cancer and structural birth defects, such as congenital heart defects, hearing loss and cleft palate. Additionally, the DRC will develop new analytical tools to provide the research community with access to this large-scale data for use in the discovery of novel and improved treatments for children diagnosed with cancer or structural birth defects.

Photo: AndreyPopov

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