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).
The antidepressant citalopram does not appear to reduce the occurrence of repetitive behaviors in children and teens with autism spectrum disorders. – Citalopram, a medication commonly prescribed to children with autism spectrum disorders (ASD), was no more effective than a placebo at reducing repetitive behaviors, according to researchers.
Interim Analyses Indicate CHAMPION Program Will Not Meet Efficacy Endpoints. Company to Continue and Accelerate Phase 2/3 Studies of Cangrelor in Settings Where Oral Drugs Cannot Be Used or Short Half-Life Is Desirable. – The Medicines Company (NASDAQ: MDCO) announced that it is discontinuing its Phase 3 CHAMPION clinical trial program of cangrelor in patients undergoing percutaneous coronary intervention (PCI).
FDA Approves Vanda Pharmaceuticals’ Fanapt(TM) for the Treatment of Schizophrenia – Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the US Food and Drug Administration (FDA) has granted marketing approval of Fanapt (iloperidone) for the acute treatment of adult patients with schizophrenia.
Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing. FDA Assigns Priority Review and PDUFA Date of October_22, 2009. – Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced that the U.S. Food and Drug Administration (FDA) has accepted the Fampridine-SR New Drug Application (NDA) for filing, assigning Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October_22, 2009.
