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Astrazeneca settles drug marketing lawsuit, plea deal rejected for possibly defective heart device maker

The New York Times: AstraZeneca has settled a case and agreed to pay $520 million after federal investigations into its marketing practices for a schizophrenia drug, Seroquel. The announcement came Tuesday from Attorney General Eric Holder. Government officials, including Health and Human Services Secretary Kathleen Sebelius, said the company paid illegal kickbacks to doctors to promote drugs for unapproved uses by children, the elderly, veterans and prisoners, which is illegal under federal law.

29 Apr 2010

Cambodia closes 64.9 percent of illegal pharmacies

In a major crackdown, Cambodia has forced nearly 65 percent of illegal pharmacies operating in the country to close within the past five months. Led by an Inter-Ministerial Committee to Fight against Counterfeit & Substandard Medicines (IMC), the shops were targeted because of evidence that they were among the primary sources of substandard and counterfeit medicines in the country.

29 Apr 2010

OSI Pharmaceuticals announces European Commission's approval of Tarceva for NSCLC

OSI Pharmaceuticals, Inc. announced today that its international partner for Tarceva® (erlotinib), Roche, received approval from the European Commission for Tarceva as a monotherapy maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged (stable disease) after platinum-based initial chemotherapy.

29 Apr 2010

Watson Laboratories sued in connection with filing of ANDA for generic version of Rapamune tablets

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Pfizer Inc. and Wyeth Pharmaceuticals Inc. in connection with the filing of Watson's Abbreviated New Drug Application for sirolimus tablets in the 1 mg and 2 mg strengths.

29 Apr 2010

Nearly all U.S. states offer HPV vaccine to adolescent girls in juvenile justice facilities: Report

Nearly all U.S. states offer the human papillomavirus vaccine to adolescent girls who have been arrested or detained, according to a new report from The Miriam Hospital and Brown University. The study, published in the May issue of the Journal of Adolescent Health, offers the first nationwide review of HPV vaccination practices among juvenile justice facilities.

29 Apr 2010

pSivida receives full payment of $15M note from Alimera Sciences

pSivida Corp., a leader in the development of ophthalmic sustained release drug delivery products, today said it had received full payment of a $15 million note, including an additional $225,000 in accrued interest, from Alimera Sciences, Inc., pSivida's licensee developing Iluvien® for the treatment of diabetic macular edema (DME).

29 Apr 2010

Talecris Biotherapeutics first-quarter net income increases 35.6% to $45.3 million

Talecris Biotherapeutics Holdings Corp. today announced its financial results for the three months ended March 31, 2010, and filed its first quarter 2010 Form 10-Q with the U.S. Securities and Exchange Commission (SEC).

29 Apr 2010

Overhaul may cost drugmakers more than expected

Bloomberg BusinessWeek: The health overhaul legislation will likely cost drugmakers $25 billion more than the $80 billion the industry anticipated when it agreed to back the Democratic-led effort, according to Wall Street analysts. "The extra costs will come from expanding drug rebates through Medicaid, the U.S. insurance program for the poor, [Leerink Swann & Co executive] John L. Sullivan said today at a Bloomberg conference in Chicago."

29 Apr 2010

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Salix Pharmaceuticals, Ltd. today announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO™ (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

29 Apr 2010

ONDCP launches new anti-meth ad campaign for Indian Country

White House Office of National Drug Control Policy Director Gil Kerlikowske today unveiled a new anti-methamphetamine ad campaign tailored for Indian Country, launched in New Mexico and in 14 other states with the largest Native American populations.

29 Apr 2010

New study reinforces urgent need for life-saving vaccines in Africa

A new study released this week in The Lancet Infectious Diseases finds that African children who contract pneumococcus - a bacterial infection that causes pneumonia, meningitis and sepsis - are 36 times as likely to have sickle-cell disease, a blood disorder prevalent in African children that increases the risk for infectious diseases and early death.

29 Apr 2010

Adolor's ENTEREG first-quarter net product sales increases to $5.3 million

Adolor Corporation today reported a net loss of $9.6 million, or $(0.21) per basic and diluted share, for the three months ended March 31, 2010, compared to a net loss of $13.2 million, or $(0.28) per basic and diluted share, for the three months ended March 31, 2009.

29 Apr 2010

Investigators study Pioglitazone and Vitamin E for treatment of NASH

A daily dose of a specific form of vitamin E significantly improved the liver disease, nonalcoholic steatohepatitis, according to a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Results were published April 28 online in the New England Journal of Medicine.

29 Apr 2010

Mylan Pharmaceuticals' ANDA for generic version of Flomax receives FDA approval

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tamsulosin Hydrochloride Capsules USP, 0.4 mg, the generic version of Boehringer Ingelheim's benign prostatic hyperplasia treatment, Flomax.

29 Apr 2010

Seasonal flu shots: Are they responsible for the adverse reactions? Investigations on

After the seasonal flu vaccines caused over 250 cases of fever, vomiting and convulsions and one reported death in under-fives there has been intense investigations to detect the cause. Further vaccinations were stopped last Friday.

28 Apr 2010

Merck disappointed with Supreme Court affirming lower court's ruling in federal securities class action suit

Merck announced today that it is disappointed with the U.S. Supreme Court's decision to affirm a lower court's ruling on when the statute of limitations began to run in a federal securities class action against the company and certain of its officers and directors. The effect of the ruling is to return the case to federal district court in New Jersey for further proceedings.

28 Apr 2010

Distinct gender differences underlying risks for abuse of prescription pain drugs: Study

There are distinct gender differences underlying the risks for abuse of prescription pain drugs, according to a Harvard study published in The Journal of Pain, the peer review journal of the American Pain Society, www.ampainsoc.org and www.jpain.org.

28 Apr 2010

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

Takeda Pharmaceutical Company Limited announced today that Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., have completed settlement agreements with six out of eight defendants in patent infringement litigation brought against these parties in response to their Abbreviated New Drug Applications for generic ACTOS® (pioglitazone HCl) and ACTOplus met® (pioglitazone HCl and metformin HCl). Takeda recently concluded litigation with the sixth settling defendant.

28 Apr 2010

AHF applauds Merck for doubling Isentress discount rebates and freezing price for ADAPs

Following an innovative, years long advocacy campaign spearheaded by AIDS Healthcare Foundation (AHF) that targeted Merck and Co. Pharmaceuticals over the pricing of its AIDS drug Isentress—one of the most expensive first line AIDS therapies on the US market today—officials from AHF lauded Merck today for significant concessions that the drug giant is putting in place on its pricing and rebate policies for the nation's AIDS Drug Assistance Programs (ADAP), the federally funded, state run programs that supply lifesaving AIDS drugs to low-income Americans in need.

28 Apr 2010

High dose B-vitamin therapy slows progression of diabetic nephropathy: Study

Patients with diabetic nephropathy (kidney disease caused by diabetes) who received high dose B-vitamin therapy experienced a more rapid decline in kidney function and had a higher rate of heart attack and stroke than patients who received placebo, according to a study in the April 28 issue of JAMA.

28 Apr 2010

Pharmaceutical News

Astrazeneca settles drug marketing lawsuit, plea deal rejected for possibly defective heart device maker

Cambodia closes 64.9 percent of illegal pharmacies

OSI Pharmaceuticals announces European Commission's approval of Tarceva for NSCLC

Watson Laboratories sued in connection with filing of ANDA for generic version of Rapamune tablets

Nearly all U.S. states offer HPV vaccine to adolescent girls in juvenile justice facilities: Report

pSivida receives full payment of $15M note from Alimera Sciences

Talecris Biotherapeutics first-quarter net income increases 35.6% to $45.3 million

Overhaul may cost drugmakers more than expected

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

ONDCP launches new anti-meth ad campaign for Indian Country

New study reinforces urgent need for life-saving vaccines in Africa

Adolor's ENTEREG first-quarter net product sales increases to $5.3 million

Investigators study Pioglitazone and Vitamin E for treatment of NASH

Mylan Pharmaceuticals' ANDA for generic version of Flomax receives FDA approval

Seasonal flu shots: Are they responsible for the adverse reactions? Investigations on

Merck disappointed with Supreme Court affirming lower court's ruling in federal securities class action suit

Distinct gender differences underlying risks for abuse of prescription pain drugs: Study

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

AHF applauds Merck for doubling Isentress discount rebates and freezing price for ADAPs

High dose B-vitamin therapy slows progression of diabetic nephropathy: Study

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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