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FDA Grants Genentech’s Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin® (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

Scientists Decode ‘Software’ Instructions of Aggressive Leukemia Cells

A team of national and international researchers, led by Weill Cornell Medical College scientists, have decoded the key “software” instructions that drive three of the most virulent forms of acute lymphoblastic leukemia (ALL). They discovered ALL’s “software” is encoded with epigenetic marks, chemical modifications of DNA and surrounding proteins, allowing the research team to identify new potential biomarkers and therapeutic targets.

Researchers Discover Blood Biomarker for Lou Gehrig’s Disease, Could Lead to New Treatments

Researchers from Brigham and Women’s Hospital (BWH) are the first to discover that changes in monocytes (a type of white blood cell) are a biomarker for amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease. This finding also brings the medical community a step closer toward a new treatment for the debilitating neurological disease that affects approximately 30,000 Americans.

Saladax Biomedical, Inc. Extends Availability of its MyCare Portfolio in Europe

Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, recently announced the company has achieved CE mark registration for its MyPaclitaxel and MyDocetaxel therapeutic dose management (TDM) MyCare assays, enabling commercialization in the European Union (EU).