Archive October 2009

[EDM]-ED Coding Update: Medicare sees increase in observation payments

Oct31

Medicare sees increase in observation payments[This quarterly column on coding in the ED is written byCaral Edelberg, CPC, CCS-P, CHC, president of Edelberg Compliance Associates, Baton Rouge, LA. If there are coding issues you would like to see addressed in this column, contact Edelberg at phone: (225) 454-0154. EFAX: (225) 612-6904. E-mail:[email protected]]Steady growth in Medicare […]

NCCN Updates NHL Guidelines Following FDA Approval of Pralatrexate

Oct31

2009 NOV 1 – (NewsRx.com) Upon the recent FDA approval of pralatrexate (Folotyn?, Allos Therapeutics, Inc.) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL), the National Comprehensive Cancer Network (NCCN) has updated the NCCN Clinical Practice Guidelines in Oncology? for Non-Hodgkin’s Lymphomas to include pralatrexate as a suggested treatment regimen (see also […]

Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia

Oct31

2009 NOV 1 – (NewsRx.com) Novartis Pharma AG has entered into an agreement for exclusive US and Canadian rights to Fanapt? (iloperidone), a new oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia. Novartis plans to launch Fanapt in the US in early […]

Solos Endoscopy, Inc.’s FDA Approved MammoView(TM) Product Line to Obtain CE Mark

Oct31

2009 NOV 1 – (NewsRx.com) Solos Endoscopy, Inc. (Pink Sheets: SNDY) is pleased to announce that the Company has taken the initial steps to obtain the CE Mark for its Food and Drug Administration (FDA) approved MammoView? line of surgical endoscopy instruments. This will allow the MammoView? line to be sold throughout the European Economic […]

ZyStor Therapeutics, Inc. Cleared to Begin Clinical Trial for Targeted Protein Therapeutic for the Treatment of Pompe Disease

Oct31

2009 NOV 1 – (NewsRx.com) ZyStor Therapeutics, Inc., a biotechnology company developing a new class of targeted protein therapeutics for the treatment of Lysosomal Storage Diseases using the Company’s proprietary Glycosylation Independent Lysosomal Targeting technology, announced that it has received clearance from the U. S. Food and Drug Administration to proceed into a clinical trial […]

ISCTM Meeting Discusses Clinical and Regulatory Aspects of Using Adaptive Designs in Clinical Trials for Central Nervous System Drug Approvals

Oct31

2009 NOV 1 – (NewsRx.com) A one day session on the use of adaptive designs for more efficient conduct of clinical trials for CNS indications chaired by Andrew C. Leon, PhD, Cornell University, and Donald Berry, PhD, M. D. Anderson, Department of Biostatistics, was held 5 October 2009, at the International Society for CNS Clinical […]

Frost & Sullivan Recognizes Agile Therapeutics for Its Innovative Weekly Low-Dose Contraceptive Patch

Oct31

2009 NOV 1 – (NewsRx.com) Based on its annual assessment of companies making innovative contributions in healthcare, Frost & Sullivan recognizes Agile Therapeutics, Inc. (Agile) with the 2009 North American Pharmaceuticals & Biotechnology Healthcare Innovation of the Year Award for its outstanding achievements in drug development. Agile’s lead product, AG200-15 with SKINFUSION?, offers great potential […]

EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimer’s Disease…

Oct31

EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimer’s Disease Patient2009 NOV 1 – (NewsRx.com) The FDA has approved a Physician-Sponsored IND and continuation of the fourth 6-month open label extension of PRX-03140, a novel 5HT4 partial agonist for the potential treatment of Alzheimer’s Disease. […]

U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

Oct31

2009 NOV 1 – (NewsRx.com) AstraZeneca (NYSE: AZN) announced the U.S. Food and Drug Administration (FDA) approved CRESTOR=AE (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased […]

CREON pancrelipase Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis

Oct31

2009 NOV 1 – (NewsRx.com) Solvay Pharmaceuticals, Inc. announced that new data confirm that CREON (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). EPI is a condition resulting from a deficiency in the production and/or secretion […]