April 2016

Cancer cells often devise ways to survive even in the presence of toxic chemotherapy. Now, a research team led by investigators at Beth Israel Deaconess Medical Center (BIDMC) has found a way to attack a process that tumor cells use to escape the effects of standard cancer drugs. The discovery is published online today in the journal Nature Cell Biology.

Researchers from Umeå University in Sweden have discovered that the single-celled parasite causing African sleeping sickness has a defence mechanism against potential pharmaceuticals under development against the disease. The deadly parasite has an enzyme that can cleave and hence disarm adenosine analogue pharmaceuticals. This according to a study recently published in the Journal of Biological Chemistry.

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Emergent BioSolutions Inc.  announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. The sBLA is supported by data that demonstrate that BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility. This submission follows the company’s successful completion of the re-analysis of data from one of more than 30 comparability assays for BioThrax manufactured in the new facility as requested by FDA.

Sosei Group Corporation (Sosei), a biopharmaceutical company, announced its wholly-owned subsidiary Heptares Therapeutics (Heptares), and Kymab Limited, a leading human monoclonal antibody biopharmaceutical company, have entered into a strategic collaboration to discover, develop and commercialise novel antibody therapeutics targeting a number of G protein-coupled receptors (GPCR) with an initial focus on immuno-oncology.

Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that it has successfully completed an End-of-Phase 2 review with the U.S. Food and Drug Administration (FDA) for OTIPRIO™ (ciprofloxacin otic suspension) in the treatment of acute otitis externa, also known as swimmer’s ear. Based on this review, the company intends to initiate a single Phase 3 clinical trial for OTIPRIO in patients with acute otitis externa during the second quarter of 2016 and expects to complete this trial and report topline results in the fourth quarter of 2016. If the results are positive then Otonomy expects to submit a supplemental New Drug Application (sNDA) to the FDA in the first half of 2017.

The U.S. Food and Drug Administration approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains.