October 2006 - FDA News

Pharma alliance builds e-gov system (FCW.com) A group of pharmaceutical

Pharma alliance builds e-gov system (FCW.com)
A group of pharmaceutical vendors has developed what might best be described as an e-government system, although it did not use any government funding. The FDA Incident Reporting System will enable pharmaceutical vendors to file electronic reports with the Food and Drug Administration on loss, theft and similar problems with drug samples, as required by the Prescription Drug Marketing Act

IBS Forges Partnership with International Quality Consulting, Extending Presence in Compliance and Quality Assurance (PR Newswire via Yahoo! Finance)
IBS America, a provider of compliance management solutions essential to creating a "Culture of Compliance," today announced a strategic partnership with International Quality Consulting , a leading business and technology consultancy.

FDA Approvals - More brand-name drug patents expiring (Honolulu Advertiser) WICHITA, Kan.

More brand-name drug patents expiring (Honolulu Advertiser)
WICHITA, Kan. Judy Beals doesn't have to take a lot of medications, but when she does, she tries to get the generic form. She has no qualms about straying from the brand name. "I don't pay nearly as much," the Wichita resident said.

DSG and Clinical Research Consultants, Inc. Develop a Global Registry for Corneal Ectasia under Sponsorship of ASCRS (Business Wire via Yahoo! Finance)
MALVERN, Pa.----DSG, Inc., a leading provider of electronic data capture software for clinical trials, and Clinical Research Consultants, Inc. , today announced that they have designed and are hosting the International Ectasia Registry sponsored by the American Society for Cataract and Refractive Surgery and developed under the direction of R.

FDA Approvals - Chembio Diagnostics to Present at 2006 C.E. Unterberg, Towbin Life

Chembio Diagnostics to Present at 2006 C.E. Unterberg, Towbin Life Sciences Conference on October 31, 2006 (Business Wire via Yahoo! Finance)
NEW YORK----Chembio Diagnostics, Inc.'s Chairman and President, Lawrence Siebert, will present at the 2006 C.E. Unterberg, Towbin Life Sciences Conference on Tuesday, October 31st at 3:30 PM at the New York Palace Hotel in New York City.

PURE Bioscience Reports Year End Results (Business Wire via Yahoo! Finance)
SAN DIEGO----PURE Bioscience today reported financial results for the year ended July 31, 2006. Revenues from continuing operations for the fiscal year were $200,400, compared with equivalent revenues of $155,800 in the prior year.

Alfacell Corporation Reports Fourth Quarter and Fiscal Year 2006 Results and Highlights (RedNova)
Alfacell Corporation (Nasdaq: ACEL) today reported financial results and key Company highlights for the fourth quarter and the 2006 fiscal year, ending July 31, 2006.

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach--Update:

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach--Update: Thursday, October 12, 2006
FDA and the State of California announced today that test results from the field investigation of the outbreak of E.coli O157:H7 in spinach are positive for E.coli O157:H7.

FDA Approvals - TYZEKA(TM) (telbivudine) Approved By U.S. Food And Drug Administration (FDA)

TYZEKA(TM) (telbivudine) Approved By U.S. Food And Drug Administration (FDA) As A New Treatment For Patients With (Medical News Today)
Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) today announced the approval of TYZEKA(TM) (telbivudine) by the U.S. Food and Drug Administration (FDA) as a new once-a-day oral treatment, taken with or without food, for patients with chronic hepatitis B (CHB). [click link for full article]

Patient Recruitment to Resume Without Modification of Protocol for Desmoteplase Phase IIB/III Stroke Study DIAS-2 (PR Newswire via Yahoo! Finance)
Forest Laboratories, Inc. and its development partner for desmoteplase, PAION AG , today announced that the independent Data Monitoring Committee for the DIAS-2 Phase IIB/III study met and informed the Steering Committee and the Companies that it has reviewed the cumulative data from the study provided by the Companies and recommended the resumption of patient enrollment into DIAS-2 with no

Protein Polymer Technologies Receives FDA 510(K) Clearance of New Indication for Embolization Convenience Kits (RedNova)
Protein Polymer Technologies, Inc. (OTCBB: PPTI), a biotechnology device company that is a pioneer in protein design and synthesis, today announced that it has received 510(k) clearance from the U.S.

Biotech's Beef (BusinessWeek) Companies say grad schools aren't stressing what

Biotech's Beef (BusinessWeek)
Companies say grad schools aren't stressing what students require in the real world

FDA Approves New Treatment for Advanced Head and Neck Cancer

FDA Approves New Treatment for Advanced Head and Neck Cancer
FDA approved Taxotere (docetaxel) Injection Concentrate for use in combination with cisplatin and fluorouracil prior to radiotherapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). This disease represents approximately 3 percent of all new cancer cases in the United States.

YourLIFE: 12 Contraception Myths Busted! ; CONFUSED ABOUT BIRTH CONTROL?

YourLIFE: 12 Contraception Myths Busted! ; CONFUSED ABOUT BIRTH CONTROL? HERE WE SORT FACT FROM FICTION AND GIVE YOU (RedNova)
By MADELEINE BAILEY CONTRACEPTION isn't exactly the most romantic thing to think about when you're in a relationship. But many women are influenced by widely-held myths - and as a result shun methods that could protect against pregnancy and STDs.

Roche Diagnostics Announces Nationwide Recall on Medical Device Used to

Roche Diagnostics Announces Nationwide Recall on Medical Device Used to Determine Blood Clotting Time
Roche Diagnostics is notifying users of an important recall of all CoaguChek PT test strips currently in the market, due to a potential for a test strip defect that may cause falsely elevated test results.

Jumbo Foods, Inc. Recalls Tuscan Sun Turkey Sandwiches Because of Possible Health Risk
The Tuscan Sun Turkey sandwiches with a Production Code of 35E was distributed in Washington, Oregon and Northern California through Convenience stores.

BIOTRONIK?s Kronos LV-T and Tupos LV/ATx Implantable Cardioverter Defibrillator Systems

BIOTRONIK?s Kronos LV-T and Tupos LV/ATx Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy
The Tupos LV/ATx and Kronos LV-T Cardiac Resynchronization Therapy Defibrillator (CRT-D) Systems are Implantable Cardioverter Defibrillators (ICDs) that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure who need an ICD (Approved: 8/10/2006)

FDA Approvals - Patient Recruitment to Resume Without Modification of Protocol for Desmoteplase

Patient Recruitment to Resume Without Modification of Protocol for Desmoteplase Phase IIB/III Stroke Study DIAS-2 (RedNova)
NEW YORK, Oct. 27 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.

Stride Arcolab's standalone net dips by 39% in Q3 (PharmaBiz)
Stride Arcolab suffered heavy setback during the third quarter ended September 2006 due to adverse forex impact, increase in R&D expenditure and lower output at US plant.

FDA Seeks Injunction Against Orthopedic Implant Device Manufacturer The FDA

FDA Seeks Injunction Against Orthopedic Implant Device Manufacturer
The FDA is seeking a permanent injunction against Endotec Incorporated of Orlando, Florida, and Michael J. Pappas, Ph.D., President; Frederick F. Buechel, M.D., Medical Director; and Jared Pappas, Director of Regulatory Affairs, to stop the illegal distribution of unapproved, total joint replacement devices.

FDA Approvals - SHIRE PLC: Excellent Q3 upgrading 2006 revenue guidance (FinanzNachrichten)

SHIRE PLC: Excellent Q3 upgrading 2006 revenue guidance (FinanzNachrichten)
Excellent third quarter with execution plan on track - upgrading 2006 revenue guidance Basingstoke, UK and Philadelphia, US - October 27, 2006 - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces results for the third quarter 2006.

Schering-Plough Announces FDA Approval Of NOXAFIL(R) (Posaconazole) For Treatment Of Oropharyngeal Candidiasis (OPC) (Medical News Today)
Schering-Plough Corporation (NYSE: SGP) today reported that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL(R) (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by the yeast Candida. [click link for full article]

Banking and Financial (Mondaq)
On September 19, 2006, the SEC s Office of the Chief Accountant (OCA) issued a letter that provides guidance regarding accounting for stock options in historical financial statements of public companies.

A Country Ruled by Faith (New York Review of Books)

A Country Ruled by Faith (New York Review of Books)
The right wing in America likes to think that the United States government was, at its inception, highly religious, specifically highly Christian, and even more specifically highly biblical.

FDA Approves New, Once-a-day COREG CR For The Treatment Of Three Key Cardiovascular Conditions (Medical News Today)
GlaxoSmithKline (NYSE: GSK) and Flamel Technologies (NASDAQ:FLML) today announced FDA approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules, for the treatment of three cardiovascular conditions: -- High blood pressure, also known as hypertension. [click link for full article]

Answerthink Receives SAP Qualification for EzMed Solution (Business Wire via Yahoo! Finance)
MIAMI----Answerthink, Inc. today announced that it has received SAP qualification for EzMed, its mySAP All-in-One partner solution for medical device manufacturers. Answerthink also announced a strategic alliance with regulatory compliance specialist Arbour Group LLC, which will offer clients products and services designed to streamline U.S.

FDA Approvals - PLC Systems Receives FDA Permission to Begin RenalGuard(TM) Investigational Study

PLC Systems Receives FDA Permission to Begin RenalGuard(TM) Investigational Study (RedNova)
FRANKLIN, Mass., Oct. 24 /PRNewswire-FirstCall/ -- PLC Systems Inc. , a company focused on innovative cardiac and vascular medical device-based technologies, announced today that the U.S.

FDA To Expedite Reviews Of Some Generic Drugs, Official Says (Medical News Today)
FDA will accelerate reviews for certain generic medications, Steven Galson, director of the agency Center for Drug Evaluation and Research, said on Wednesday, Reuters/Los Angeles Times reports. According to Galson, FDA will accelerate reviews for the first generic versions of brand-name medications that no longer have patent or market exclusivity protection. [click link for full article]

Protein Polymer Technologies Receives FDA 510(k) Clearance of New Indication for Embolization Convenience Kits (SYS-CON Media)
Protein Polymer Technologies, Inc. (OTCBB: PPTI), a biotechnology device company that is a pioneer in protein designand synthesis, today announced that it has received 510(k) clearance fromthe U.S. Food and Drug Administration (FDA) to market its PVA foamembolization convenience kits for peripheral vascular indications includingtreatment of liver and renal tumors. The products were previously

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach--Update:

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach--Update: Thursday, October 12, 2006
FDA and the State of California announced today that test results from the field investigation of the outbreak of E.coli O157:H7 in spinach are positive for E.coli O157:H7.

Hotline: (Canberra City News) It was terrifying. I felt like

Hotline: (Canberra City News)
It was terrifying. I felt like I was being drained I lost the strength in my left arm, suffered facial drooping and slurred speech. My body failed me and I didn t know why, said Kate Seselja.

A call for progressive breeders to bed down already (San Francisco Chronicle)
Let this be your rallying cry. Let it be your new hot-button topic, a raw, naked, condomless, blog-ready, wildfire, underground, grassroots crusade, your juiciest of incentive programs, your inspired call to hot, naked, impregnable sperm-a-riffic action.

PhiCal? Fecal Calprotectin Immunoassay The PhiCal? Fecal Calprotectin Immnoassay is

PhiCal? Fecal Calprotectin Immunoassay
The PhiCal? Fecal Calprotectin Immnoassay is a lab test that measures the amount of fecal calprotectin in a patient?s stool sample. High levels of fecal calprotectin may be an indication of inflammatory bowel disease (IBD). Common forms of IBD include... (Approved: 4/26/2006)

FDA Issues Nationwide Alert on Counterfeit One Touch Basic/Profile and

FDA Issues Nationwide Alert on Counterfeit One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
The U.S. Food and Drug Administration (FDA) is alerting the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose.

Snack Alliance, Inc. Issues Allergy Alert on Undeclared Soy Protein in Nacho Flavored Tortilla Chips
Packages of Nacho flavored tortilla chips having a best by date (which can be found in the upper right hand corner of packages) prior to and including FEBRUARY 7, 2007 distributed in retail stores.

Pacific Coast Fruit Company Voluntarily Recalls Spinach Salad Products and Pizza Because of Possible Health Risk
Pacific Coast Fruit Company of Portland, Oregon is recalling products that may include spinach supplied by Natural Selections Foods a California Grower and Processor.

FDA Approvals - THE PIPELINE CRISIS (PharmaBiz) Global pharmaceutical industry is facing, perhaps,

THE PIPELINE CRISIS (PharmaBiz)
Global pharmaceutical industry is facing, perhaps, one of the worst ever crises today. This industry thrives on a steady stream of new molecules from its research pipelines and their success as blockbusters in the market place.

PLC Systems Receives FDA Permission to Begin RenalGuard(TM) Investigational Study (RedNova)
FRANKLIN, Mass., Oct. 24 /PRNewswire-FirstCall/ -- PLC Systems Inc. , a company focused on innovative cardiac and vascular medical device-based technologies, announced today that the U.S.

Novartis: Gleevec gains approval for five more indications (Pharmaceutical Business Review)
Novartis Gleevec has now garnered simultaneous approval for the treatment of one solid tumor and four rare blood disorders. However, given the relatively small patient population groups within these diseases, expansion into these indications is unlikely to significantly enhance Gleevec s sales.