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Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a study comparing the effect of long-term treatment with either BYETTA® (exenatide) injection or Lantus® (insulin glargine) on overall beta-cell function. (Beta cells are cells in the pancreas that produce insulin.) Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

30 Jun 2010

FDA grants approval for first generic version of Effexor XR antidepressant capsules

On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.

30 Jun 2010

Preliminary findings show RA drug reduces brain damage in stroke patients

A drug used to treat rheumatoid arthritis also reduces the damage a stroke inflicts on the brain according to lab research and preliminary findings from a clinical trial of stroke patients. The results open the door for a larger clinical study to refine the drug anakinra's use as an effective therapy for victims of stroke.

From The University of Manchester 30 Jun 2010

Erye's new facility passes SFDA inspection for manufacture of penicillin, cephalosporin powder

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced on June 15, 2010 that its 51% owned Suzhou Erye pharmaceutical subsidiary passed the government inspection by the State Food and Drug Administration ("SFDA") in China to manufacture penicillin and cephalosporin powder for injection at its new manufacturing facility.

30 Jun 2010

Survey of doctors suggests widespread 'defensive medicine'

HealthDay/Bloomberg Businessweek reports that a new survey published in the Archives of Internal Medicine shows that 91 percent of 2,416 doctors believe their colleagues practice defensive medicine by giving patients more tests and treatments as a means of protecting themselves from lawsuits. "In addition, 90.7 percent of the respondents believe better protection against unwarranted malpractice suits is necessary to reduce the number of unnecessary medical tests" (Preidt, 6/28).

30 Jun 2010

Doctors want pain drugs to be tracked

The Hill: Doctors who belong to the American Society of Interventional Pain Physicians want lawmakers to give money to help states begin collecting and sharing data on patients who "doctor shop" for pain medications. The group wants $55 million for the program and are asking Congress "to reauthorize a 2005 bill providing grants to states that collect prescription drug information and share it with physicians and pharmacists — and law enforcement officials when there's an investigation — while protecting patients' privacy.

30 Jun 2010

UCLA School of Dentistry awarded NIH grant to study methamphetamine's oral, dental health consequences

The abuse of methamphetamine - a powerful and highly addictive psychostimulant that is toxic to the nervous system - has reached epidemic proportions in many parts of the United States. The National Institute on Drug Abuse estimates that more than 10 million Americans have tried methamphetamine, while more than 1.4 million are habitual users.

30 Jun 2010

US District Court upholds validity and enforceability of CRESTOR patent

AstraZeneca announced today that Judge Joseph Farnan, Jr., US District Court, District of Delaware, has found that the substance patent protecting CRESTOR (RE37,314 – the '314 patent) is valid and enforceable. In its ruling, the court found that no inequitable conduct was committed by any Shionogi employee. The court also held the '314 patent to be non-obvious and properly reissued.

30 Jun 2010

Greenwire/New York Times examine dengue vaccine development

Greenwire/New York Times reports on the growing number of cases of dengue worldwide, including the CDC's report last month that the virus has now been locally acquired in the continental U.S. for the first time in 65 years. "While a few cases were reported earlier, they were primarily in Americans who had caught the virus abroad or at the Texas-Mexico border," the news service writes.

30 Jun 2010

Alimera submits Iluvien NDA for DME to FDA

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).

29 Jun 2010

BBD reports analyze effectiveness and safety of statin use

A series of new reports from Consumer Reports Best Buy Drugs (BBD) caution that the benefits of statin use by children and some women may not outweigh the risks. Drugs to lower cholesterol - including statins - are the most commonly prescribed drugs in the U.S. and garnered more than $14 billion in sales last year.

29 Jun 2010

Mylan Pharmaceuticals receives FDA final approval for Anastrozole Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1 mg, the generic version of AstraZeneca's Arimidex® Tablets, a treatment for early breast cancer.

29 Jun 2010

AlphaRx regains all rights to Indaflex from Cypress Bioscience

AlphaRx, Inc. today announced that it has entered into an agreement with Cypress Bioscience, under which AlphaRx is regaining all rights to Indaflex(TM) from Cypress Bioscience, which AlphaRx had previously licensed to Proprius Pharmaceuticals, which was subsequently acquired by Cypress Bioscience.

29 Jun 2010

PROLOR Biotech receives EU GMP certification for hGH-CTP biobetter version of human growth hormone

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that it has received formal Good Manufacturing Practice (GMP) certification for hGH-CTP, the company's proprietary biobetter version of human growth hormone. GMP certification is required by the European Union (EU) clinical trials legislation as a precondition for conducting clinical trials in EU member countries.

29 Jun 2010

Rosiglitazone therapy associated with increased risk for heart attack: Study

Eleven years after the introduction of the diabetes drug rosiglitazone, data from available clinical trials demonstrate an increased risk for heart attack associated with its use and suggest an unfavorable benefit-to-risk ratio, according to a report posted online today that will appear in the July 26 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

29 Jun 2010

Statins does not reduce death risk in high-risk individuals without heart disease

A meta-analysis of previously published studies finds no evidence that statins are associated with a reduced risk of death among individuals at risk for but with no history of cardiovascular disease, according to a report in the June 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals

29 Jun 2010

Lantus and Apidra improve outcomes, decrease glycemic variability: Study

Sanofi-aventis announced today results of a study which demonstrated that patients using Lantus® (insulin glargine [rDNA origin] injection) once-daily and Apidra® (insulin glulisine [rDNA origin] injection) before meals reported improved patient reported outcomes and decreased glycemic variability versus premix analog insulin. Two abstracts from this study were highlighted at the American Diabetes Association's 70th Annual Scientific Sessions (ADA).

29 Jun 2010

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.

29 Jun 2010

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Daiichi Sankyo, Inc. and Eli Lilly and Company appreciate the availability of a "Clinical Alert" from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) in response to the FDA's Boxed Warning about Plavix® (clopidogrel), and commend the leading cardiovascular medical societies for providing perspective on the importance of genetic make-up and the variability in response of certain oral anti-platelet (OAP) therapy for patients with acute coronary syndrome (ACS) who are managed with angioplasty and stenting (known as PCI).

29 Jun 2010

Study: Statins can reduce risk of prostate cancer recurrence after surgery

Men who use statins to lower their cholesterol are 30 percent less likely to see their prostate cancer come back after surgery compared to men who do not use the drugs, according to researchers at Duke University Medical Center. Researchers also found that higher doses of the drugs were associated with lower risk of recurrence.

29 Jun 2010