Brain imaging may help diagnose autism — Subtle language delay, visible in MEG, may flag disorder – Children with autism spectrum disorders (ASDs) process sound and language a fraction of a second slower than children without ASDs, and measuring magnetic signals that mark this delay may become a standardized way to diagnose autism.
Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for FUSILEV(R) in Advanced Metastatic Colorectal Cancer – A Complete Response letter is issued by the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer.
deCODE Discovers Four New Risk Factors for Prostate Cancer – deCODE genetics (Nasdaq:DCGN) announced that a team of its scientists and academic colleagues from Finland, Spain, the Netherlands and the United States have published the discovery of four novel single-letter variations in the sequence of the human genome (SNPs) conferring increased risk of prostate cancer.
Eurand Granted FDA Approval for ZENPEP(TM) — First and Only FDA-Approved Pancreatic Enzyme Product Clinically Tested in Patients Under 12 Years Old. – U.S. Food and Drug Administration (FDA) has approved Eurand’s New Drug Application (NDA) for ZENPEP(TM) (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.
Contrave Helps Obese Patients Initiate and Sustain Meaningful Weight Loss, Improves Multiple Cardiometabolic Risk Factors and Reduces Food Cravings. – Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that all three remaining Phase 3 trials evaluating Contrave(R) (bupropion SR/naltrexone SR), its investigational drug for the treatment of obesity, met their co-primary endpoints.
Lupus Research Institute Highly Encouraged by Benlysta Trial Results — First Phase 3 Lupus Drug Trial in Decades to Show Effectiveness. – Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) announced that BENLYSTA (belimumab, formerly LymphoStat-B?) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE).
Children with FASD have more severe behavioral problems than children with ADHD – Children with fetal alcohol spectrum disorders (FASD) have a high risk of psychiatric problems, particularly attention deficit hyperactivity disorder (ADHD), conduct disorder, or both.
BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza – BioCryst Pharmaceuticals (Nasdaq: BCRX) announced positive results from two Phase 3 studies of intravenous (i.v.) peramivir in patients with seasonal influenza.
Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter – Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, for use in both permanent and retrievable indications.
Palomar Receives FDA Over-The-Counter Clearance for a Home Use Wrinkle Removal Laser Device – Clearance Opens Door To Multi-Billion Dollar Home Skin Care Market. – US health agency FDA (Food and Drug Administration) approved over-the-counter (OTC) marketing of Palomar’s laser device for treatment of wrinkles around the eyes, i.e. periorbital wrinkles.
ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema – Company Also Granted Expansion of Prophylaxis Therapy Label to Include Patient Labeling for Self-Administration. – ViroPharma Incorporated (Nasdaq: VPHM) announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to its supplemental Biologics License Application (sBLA) for Cinryze(TM) (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE).
Clinical Data, Inc. Announces Positive Results from Second Phase III Trial of Vilazodone for Depression – Clinical Data, Inc. (NASDAQ: CLDA) announced positive top-line results from the second of two Phase III trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD).
