Three former Genentech executives launched biopharmaceutical company Denali Therapeutics with $217 million. Forbes reported that the venture capital funding is the largest in biotech history. The founders are Ryan Watts, Genentech’s former director of neuroscience; Alex Schuth, Genentech’s former director and head of neuroscience; and Marc Tessier-Lavigne, whom Forbes noted led Genentech’s research during its “legendary run in the late 2000s.” Denali will focus on developing drugs to treat central nervous system diseases like Parkinson’s disease and amyotrophic lateral sclerosis.
Mallinckrodt accused the FDA of overstepping its authority in a generics substitution lawsuit, reported The Wall Street Journal. The lawsuit is over the FDA’s November decision that two generic versions of Johnson & Johnson’s ADHD drug Concerta could not automatically be substituted for the branded drug because testing showed they were not absorbed in the body in the same way. The generic versions are made by Mallinckrodt and UCB. The FDA said the two companies had six months to show their generics were absorbed in the same manner, but that deadline passed.
Sanofi expanded a 2012 collaboration with Selecta Biosciences to include developing a celiac-disease treatment, BioPharma Dive reported. The agreement gives Sanofi exclusive rights to immunotherapies that address food allergen responses and two other treatments that address allergies and celiac disease.
The Cleveland Clinic and Human Longevity, a genomic sequencing firm, will sequence blood samples from the Cleveland Clinic’s GeneBank study. The goal is to identify disease-associated genes and possible treatment pathways using blood that was collected from heart catheterization patients as part of the study.
A new kit from the National Institute of Standards and Technology can help labs prove the accuracy of genetic tests. The kit works like a calibration tool by using a specific DNA sequence as the test case. The New York Times said the right answers—finding the same mutations in the same places—show the tests are accurate. NIST said this can reassure insurers that test results are reliable and may encourage them to more broadly cover gene-sequencing tests.