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Teva Pharmaceutical Industries reaches settlement in principle to resolve claims under federal, state False Claims Acts

Teva Pharmaceutical Industries Ltd. announced today that several of its subsidiaries in the United States reached a settlement in principle to resolve claims brought by Ven-A-Care of the Florida Keys, Inc. on behalf of the United States, Texas, Florida, and California under federal and state False Claims Acts.

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

State policy developments: Iowa seeks to extend birth control coverage; Minn. eyes more health care for poor; Miss. drug settlement

BusinessWeek: "Mississippi will receive $18.5 million from drug maker Eli Lilly and Co. as part of a settlement over claims the company promoted the anti-psychotic Zyprexa for ailments it was not federally approved to treat, Attorney General Jim Hood said Thursday" (Byrd, 2/4).

6 Feb 2010

Health bill stall creates uncertainty for drug makers

"With the possible demise of health care legislation, getting back to business as usual may not be the best thing for the nation's drug makers," The New York Times reports. "After all, in return for the prospect of tens of millions of newly insured customers and a large degree of regulatory certainty, the pharmaceutical industry had agreed to pay a relatively small price: $8 billion a year in discounts and fees.

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

FDA grants Talecris Biotherapeutics orphan drug designation for Alpha1-Proteinase Inhibitor to treat AAT deficiency

Talecris Biotherapeutics, Inc. announced today that it was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency. AAT deficiency is a chronic, hereditary condition that increases the risk of certain diseases, especially emphysema, which typically emerges in the fourth decade of life. Currently, there are no approved, inhaled treatments available for the treatment of AAT deficiency.

5 Feb 2010

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.

5 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

'Doctor Shopping': Data from California's prescription monitoring program

Research presented at the American Academy of Pain Medicine's 26th Annual Meeting provides early published data analyzing information gathered from California's prescription monitoring program, known as the Controlled Substances Utilization Review and Evaluation System (CURES). The analysis found a two-fold increase in the likelihood of individuals receiving opioids from multiple providers or "doctor shopping" when they were also being simultaneously prescribed a single additional class of a controlled substances, such as benzodiazepines or amphetamines.

5 Feb 2010

New ICD-9-CM database provides FDA-approved and off-label uses for therapeutic drugs

A recently released Drug Diagnosis Coding database from RJ Health Systems provides accurate FDA-approved and Compendia-listed off-label uses for therapeutic classes such as Oncology, Anti-Emetics, Erythropoietin Stimulating Agents and Multiple Sclerosis Agents. The

5 Feb 2010

Emerson Ecologics officially launches Emerson Quality Program

Emerson Ecologics, LLC announces the official launch of the Emerson Quality Program(SM) (EQP) on their website, www.emersonecologics.com/quality. This one-of-a-kind quality assurance program for the nutritional supplements industry will showcase the quality practices of the industry's leading manufacturers.

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

New report finds low adult vaccination rates in U.S.

A new report, Adult Immunization: Shots to Save Lives, released today by the Trust for America's Health (TFAH), the Infectious Diseases Society of America (IDSA), and the Robert Wood Johnson Foundation (RWJF) found that more than 30 percent of adults ages 65 and older had not been immunized against pneumonia in 36 states as of 2008.

5 Feb 2010

Mylan first to file ANDA patent for Caduet Tablets

Mylan Inc. today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg.

5 Feb 2010

Report shows more Americans are buying prescription drugs to treat digestive conditions

The number of Americans buying prescription drugs to treat digestive conditions climbed over 50 percent, rising from 18.1 million to 29 million people between 1997 and 2007, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

5 Feb 2010

Elephantiasis and river blindness: MSU researcher receives $2M for reformulating flubendazole

In an effort to eliminate the tropical diseases elephantiasis and river blindness, a Michigan State University researcher has been awarded $2 million to reformulate an existing drug that could stop the debilitating diseases in their tracks.

5 Feb 2010

New class of compound could become effective antidepressant with minimal side effects

Chemists at Oregon State University have discovered and synthesized a new compound that in laboratory and animal tests appears to be similar to, but may have advantages over one of the most important antidepressant medications in the world.

5 Feb 2010

Early stage trial finds malaria vaccine effectively protected young children, study says

An experimental vaccine was found to effectively protect young children from malaria in Mali, Reuters reports. According to the news service, "The vaccine, which uses an immune system booster called an adjuvant from British drugmaker GlaxoSmithKline, targets the malaria parasite as it is actively infecting red blood cells and causing fever and illness" (Steenhuysen, 2/3).

5 Feb 2010

Children exposed to acetaminophen prenatally more likely to have asthma symptoms at age five

Children who were exposed to acetaminophen prenatally were more likely to have asthma symptoms at age five in a study of 300 African-American and Dominican Republic children living in New York City.

5 Feb 2010

Pfizer, DxS sign agreement to develop a diagnostic test kit for CDX-110 to treat patients with GBM

Pfizer Inc. and DxS (a wholly owned subsidiary of QIAGEN N.V.) today announced that they have entered into an agreement to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM).

5 Feb 2010

Pharmaceutical News

Teva Pharmaceutical Industries reaches settlement in principle to resolve claims under federal, state False Claims Acts

AMAG Pharmaceuticals releases safety update on Feraheme Injection

State policy developments: Iowa seeks to extend birth control coverage; Minn. eyes more health care for poor; Miss. drug settlement

Health bill stall creates uncertainty for drug makers

Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

FDA grants Talecris Biotherapeutics orphan drug designation for Alpha1-Proteinase Inhibitor to treat AAT deficiency

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

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

'Doctor Shopping': Data from California's prescription monitoring program

New ICD-9-CM database provides FDA-approved and off-label uses for therapeutic drugs

Emerson Ecologics officially launches Emerson Quality Program

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

New report finds low adult vaccination rates in U.S.

Mylan first to file ANDA patent for Caduet Tablets

Report shows more Americans are buying prescription drugs to treat digestive conditions

Elephantiasis and river blindness: MSU researcher receives $2M for reformulating flubendazole

New class of compound could become effective antidepressant with minimal side effects

Early stage trial finds malaria vaccine effectively protected young children, study says

Children exposed to acetaminophen prenatally more likely to have asthma symptoms at age five

Pfizer, DxS sign agreement to develop a diagnostic test kit for CDX-110 to treat patients with GBM

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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