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FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data.

8 Feb 2010

Anthera Pharmaceuticals reaches agreement with the FDA on SPA for VISTA-16 clinical study

Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, announced today that it reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 clinical study named VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks) for its lead product candidate, A-002, an oral sPLA2 inhibitor, in combination with HMG-CoA reductase inhibitor, or statin, therapy for short-term (16-week) treatment of patients experiencing an acute coronary syndrome.

8 Feb 2010

Community Health Navigator Program for Houston's Burmese refugees may become a national model

The Physician Assistant Foundation (PAF), Baylor College of Medicine and other local partners today unveiled their unique approach to providing health care and social services to Burmese refugees in Houston, with hopes the program could become a model for meeting similar needs of refugees across the country.

8 Feb 2010

Oral care with ionic toothbrush

Smile and the world smiles with you. Well, the folks at Global Ionics LLC, makers of the Ionic ProClean toothbrush, are smiling a lot these days; especially since receiving the impressive results of a clinical evaluation conducted by THE DENTAL ADVISOR. In a clinical assessment, the Ionic ProClean was evaluated by a team of dental professionals and 107 patients in over 11,100 uses. The results? Dental professionals reported that they observed less tartar buildup and gingivitis, and believed the toothbrush contributed to good oral hygiene: earning the Ionic ProClean a 4+ rating from THE DENTAL ADVISOR.

6 Feb 2010

Research roundup: Medicare spending, community health centers, children's dental services

Health Affairs: Prices Don't Drive Regional Medicare Spending Variations - "Per capita Medicare spending is more than twice as high in New York City and Miami than in places like Salem, Oregon.

6 Feb 2010

AMAG Pharmaceuticals releases safety update on Feraheme Injection

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety update on Feraheme® (ferumoxytol) Injection for intravenous use.

6 Feb 2010

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

6 Feb 2010

Pharma IQ to organize 4th Improving Solubility conference at The Park Hyatt in Philadelphia

Organized by Pharma IQ, a division of IQPC, the 4th Improving Solubility conference will be held March 29-31, 2010 at The Park Hyatt in Philadelphia, PA. This forum brings together pharmaceutical researchers and scientists to uncover advances in enhancing solubility, amorphous forms, bioavailability & lipid-based formulation of drugs.

From IQPC Ltd 5 Feb 2010

Intrathecal drug delivery cost effective for chronic pain treatments

Estimates of pain care treatment costs exceed $1 billion annually in the United States. Today at the American Academy of Pain Medicine's 26th Annual Meeting two abstracts looked at the issue. One evaluated intrathecal drug delivery (a targeted medicine delivery system) that could save costs over time. The other analyzed the differences between the costs of treatment for chronic pain treatments.

5 Feb 2010

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

ACCESS PHARMACEUTICALS, INC. announced today that it initiated an internal pre-licensing program to confirm the utility of its proprietary Cobalamin (vitamin B12) platform technology for targeted delivery of siRNA therapies. The program is considered important because, despite the widely publicized potential of RNA therapy, researchers up to now have been stymied in their efforts to design a pharmaceutical product that efficiently transports siRNA therapeutics into the cells they are designed to inhibit or kill.

5 Feb 2010

Pazopanib drug slows the progression of RCC in patients by 54%

The drug pazopanib (Votrient) slowed the progression of advanced renal cell carcinoma (RCC), a form of kidney cancer, in patients by 54% percent, according to a new study published in the Journal of Clinical Oncology.

5 Feb 2010

Aradigm's first U.S. sale of SUMAVEL DosePro needle-free delivery system triggers $4M milestone payment

Aradigm Corporation announced today that it received the $4 million milestone payment from Zogenix, Inc. (“Zogenix”) based upon the first commercial sale in the U.S. of SUMAVEL* DosePro* (sumatriptan injection) needle-free delivery system. The Company will receive quarterly royalty payments on all SUMAVEL DosePro sales. In 2006, the Company sold all assets related to the Intraject* needle-free injector technology (now rebranded as DosePro) to Zogenix in exchange for milestone and royalty payments.

5 Feb 2010

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Protalix Biotherapeutics, Inc. today announced that data from its pivotal Phase III trial of taliglucerase alfa in patients with Gaucher disease will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010, February 10-12, 2010 in Miami, Florida.

5 Feb 2010

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

5 Feb 2010

Progenics Pharmaceuticals to present preclinical data of multiplex PI3K inhibitors

Progenics Pharmaceuticals, Inc. today announced the presentation of preclinical data on a series of novel compounds that simultaneously blocked two critical pathways involved in the growth and survival of cancer cells.

4 Feb 2010

Shire's clinical study results for treatment of Gaucher disease to be presented at LDN World Symposium

Shire plc, the global specialty biopharmaceutical company, today announced that data from one of three Phase III clinical trials for velaglucerase alfa, the company's enzyme replacement therapy (ERT) in development for the treatment of Type 1 Gaucher disease, will be presented at the Lysosomal Disease Network (LDN) World Symposium, February 10-12, 2010 in Miami, Florida.

4 Feb 2010

GKAS volunteers provide free dental care for children

With an economy that might cause some parents to postpone regular dental visits for their children and tooth decay being the most prevalent chronic disease in America's children, the American Dental Association (ADA) is mobilizing dental professionals for the eighth consecutive year in a national campaign to extend necessary care to children and adolescents from low-income families.

4 Feb 2010

HealthSport's bi-layer edible film strip technology related patent application receives Mexican approval

HealthSport, Inc., the preeminent formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion, announced today that the Mexican Institute of Industrial Property has approved HealthSport's patent application relating to its bi-layer edible film strip technology.

4 Feb 2010

Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

Oral News and Research

FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

Anthera Pharmaceuticals reaches agreement with the FDA on SPA for VISTA-16 clinical study

Community Health Navigator Program for Houston's Burmese refugees may become a national model

Oral care with ionic toothbrush

Research roundup: Medicare spending, community health centers, children's dental services

AMAG Pharmaceuticals releases safety update on Feraheme Injection

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Pharma IQ to organize 4th Improving Solubility conference at The Park Hyatt in Philadelphia

Intrathecal drug delivery cost effective for chronic pain treatments

Access Pharmaceuticals initiates Cobalamin technology program for targeted delivery of siRNA therapies

Pazopanib drug slows the progression of RCC in patients by 54%

Aradigm's first U.S. sale of SUMAVEL DosePro needle-free delivery system triggers $4M milestone payment

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Progenics Pharmaceuticals to present preclinical data of multiplex PI3K inhibitors

Shire's clinical study results for treatment of Gaucher disease to be presented at LDN World Symposium

GKAS volunteers provide free dental care for children

HealthSport's bi-layer edible film strip technology related patent application receives Mexican approval

Phase 2a clinical trial results of VX-809 in patients with CF announced

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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