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Opinions: Haiti corruption; Financial sector tax, G8 promises; Investing in women

A Washington Post editorial reflects on Haitian President Rene Preval's response to U.S. policy makers' queries "about the perils of corruption and what measures the Haitian government might devise to minimize misuse and theft of the billions of dollars in recovery assistance flowing into the country and the billions more expected" during his visit this week to Washington D.C. "Surprisingly, he seems utterly unprepared to discuss the matter," the editorial notes.

12 Mar 2010

Bayer HealthCare Pharmaceuticals' ciprofloxacin DPI granted FDA orphan drug designation for CF treatment

Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration for ciprofloxacin dry powder inhaler for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients. A similar designation has already been granted by the European Medicines Agency.

12 Mar 2010

Boston Scientific's Express LD Iliac Premounted Stent System for use in iliac arteries receives FDA approval

Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved its Express® LD Iliac Premounted Stent System for use in iliac arteries. The Express LD Iliac Stent is the first and only low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease. The Company said it plans to launch the product immediately in the United States.

12 Mar 2010

bioMerieux introduces FDA cleared chromID VRE for detecting Enterococcus faecium and Enterococcus faecalis

bioMerieux – a world leader in the field of in vitro diagnostics – today announced the launch of the first Food and Drug Administration (FDA) cleared chromID™ VRE, a simple and cost-effective solution in the struggle against vancomycin-resistant enterococci (VRE). chromID VRE is the first to receive an FDA 510(k) clearance for the qualitative detection of Enterococcus faecium and Enterococcus faecalis showing acquired resistance to vancomycin in stool specimens.

12 Mar 2010

PhRMA spends $6.3 million lobbying in fourth quarter, slight increase from year before

The Pharmaceutical Research and Manufacturers of America spent $6.3 million lobbying Congress and other government arms on health care in the fourth quarter of 2009, The Associated Press reports. PhRMA "spent just 2 percent more than the $6.17 million it paid out for lobbying in the year-ago period.

12 Mar 2010

Novel mutation in gene encoding ankyrin-B increases risk of type 2 diabetes

Alterations in our response to the taste or smell of food may be another culprit responsible for Type 2 diabetes, according to scientists at Duke University Medical Center who have identified the specific mechanism in human specimens and in mice.

12 Mar 2010

Does Medicare 'doughnut hole' spur increase in foreign drug imports?

Medill Reports: "Unless federal legislation closes the Medicare coverage gap colloquially known as the 'doughnut hole,' seniors may opt for online drug imports to alleviate steep prescription costs. ... 'As seniors start falling into the doughnut hole, they are going online to find deals on prescription drugs, whether they're based in the U.S. or in other countries,' said Gabriel Levitt, vice president of PharmacyChecker.com LLC, a leader in the evaluation of online and mail-order pharmacies in both the U.S. and abroad.

12 Mar 2010

Azur Pharma to acquire PRIALT analgesic therapy from Elan Pharmaceuticals

Azur Pharma Limited today announced it has signed a definitive agreement with Elan Pharmaceuticals, Inc. (a subsidiary of Elan Corporation, plc) to acquire the analgesic therapy, PRIALT(R) (ziconotide intrathecal infusion).

12 Mar 2010

Covidien to use FDA, Health Canada approved Mo 99 from Maria for manufacturing Tc 99m generators

Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor (Maria) in Poland as a site to irradiate highly-enriched uranium targets for Molybdenum 99 (Mo 99) production. Covidien will use the Mo 99 obtained from Maria in the manufacture of its Technetium 99m (Tc 99m) generators. Patients should begin to benefit from Maria-produced Mo 99 in the United States and Canada later this month.

12 Mar 2010

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

The U.S. Food and Drug Administration has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer. Palliative treatment helps to relieve symptoms associated with advanced prostate cancer.

12 Mar 2010

Study explores incidence of eating disorders among type 1 diabetic patients

Diabetics, under the gun to better manage their disease by controlling their food intake and weight, may find themselves in the sticky wicket of needing treatment that makes them hungry, researchers said.

12 Mar 2010

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

FDA warns healthcare professionals about bogus surgical mesh products

The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

11 Mar 2010

Collaborative center established to reduce obesity-related deaths in African-American and Latino communities

A $6 million grant from the National Heart, Lung and Blood Institute (NHLBI) has funded the creation of ORBIT: Obesity Related Behavioral Intervention Trials to focus on reducing obesity and obesity-related deaths in New York City's African-American and Latino communities.

11 Mar 2010

FDA provides guidance on Restanza clinical program in treatment of CABP

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration has provided guidance on the clinical program required to assess the approvability of Restanza™ (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia.

11 Mar 2010

Advanced Life Sciences Holdings reports decrease in net loss for full-year 2009

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2009.

11 Mar 2010

Evaluating true toxicity of drugs: Changes in collecting and reporting adverse symptom information needed

A Perspective piece in the New England Journal of Medicine calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration (FDA), and how the FDA represents this information on drug labels.

11 Mar 2010

Rex Medical receives FDA Clearance for Cleaner Rotational Thrombectomy System

Rex Medical, L.P., today announced that it has received 510(k) Clearance from the U.S. Food and Drug Administration for the Cleaner™ Rotational Thrombectomy System. Cleaner™ technology is indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.

11 Mar 2010

StemCells reports net loss of $5.23M for fourth-quarter fiscal 2009

StemCells, Inc. today reported financial results for the fourth quarter and year ended December 31, 2009. The Company's results include the operations of Stem Cell Sciences Plc (SCS) since April 1, 2009.

11 Mar 2010

Non-smoked medical cannabis products needed, says National Drug Control Policy Deputy Director

Cannabis Science, Inc., a pioneering US pharmaceutical cannabis company, notes that comments by President Obama's Deputy Director of the White House Office of National Drug Control Policy, Tom McClellan, in yesterday's USA TODAY pinpoints the need for non-smoked medical cannabis products similar to those currently being developed for FDA clinical trials by Cannabis Science.

11 Mar 2010

Food News and Research

Opinions: Haiti corruption; Financial sector tax, G8 promises; Investing in women

Bayer HealthCare Pharmaceuticals' ciprofloxacin DPI granted FDA orphan drug designation for CF treatment

Boston Scientific's Express LD Iliac Premounted Stent System for use in iliac arteries receives FDA approval

bioMerieux introduces FDA cleared chromID VRE for detecting Enterococcus faecium and Enterococcus faecalis

PhRMA spends $6.3 million lobbying in fourth quarter, slight increase from year before

Novel mutation in gene encoding ankyrin-B increases risk of type 2 diabetes

Does Medicare 'doughnut hole' spur increase in foreign drug imports?

Azur Pharma to acquire PRIALT analgesic therapy from Elan Pharmaceuticals

Covidien to use FDA, Health Canada approved Mo 99 from Maria for manufacturing Tc 99m generators

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

Study explores incidence of eating disorders among type 1 diabetic patients

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

FDA warns healthcare professionals about bogus surgical mesh products

Collaborative center established to reduce obesity-related deaths in African-American and Latino communities

FDA provides guidance on Restanza clinical program in treatment of CABP

Advanced Life Sciences Holdings reports decrease in net loss for full-year 2009

Evaluating true toxicity of drugs: Changes in collecting and reporting adverse symptom information needed

Rex Medical receives FDA Clearance for Cleaner Rotational Thrombectomy System

StemCells reports net loss of $5.23M for fourth-quarter fiscal 2009

Non-smoked medical cannabis products needed, says National Drug Control Policy Deputy Director

Understanding cultivated meat and its global potential eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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