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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

Combination therapy for severe depression

Severe depression is life threatening. So it is worth every effort to get depression under control and make life more manageable. For most people, that means some combination of antidepressant drugs and talk therapy.

29 Jun 2010

Health Canada recommends new pneumococcal vaccine for young children

In December, 2009, Health Canada approved a new vaccine for children aged six weeks through five years to prevent infections caused by the bacteria called pneumococcus or Streptococcus.

29 Jun 2010

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).

29 Jun 2010

FDA approves Teva's generic Effexor XR antidepressant

Teva Pharmaceutical Industries Ltd. announced today U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.

29 Jun 2010

Rosiglitazone associated with increased risk of serious cardiovascular events compared with pioglitazone

A new study published online today by JAMA shows that among patients age 65 years and older, rosiglitazone (a medication for treating Type 2 diabetes) is associated with an increased risk of stroke, heart failure, and all-cause mortality (death) when compared with pioglitazone (another medication for diabetes). The study was published online today in advance of an upcoming Food and Drug Administration meeting that will review the safety of rosiglitazone. The paper will appear in the July 28 print issue of JAMA.

29 Jun 2010

APP to market Anastrozole 1 mg tablets in U.S.

Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that APP Pharmaceuticals will immediately begin marketing Anastrozole tablets in the U.S., after the U.S. Food and Drug Administration granted approval to market the breast cancer treatment medication to Fresenius Kabi Oncology Limited.

29 Jun 2010

EpiCept requests FDA priority review of Ceplene NDA for AML

EpiCept Corporation announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ceplene® (histamine dihydrochloride). EpiCept is seeking approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission.

29 Jun 2010

FDA's acceptance for filing of DM-1796 NDA triggers $10M milestone payment to Depomed

Depomed, Inc. today announced that it has received a $10 million milestone payment from Abbott Products, Inc., its licensee of DM-1796, for the U.S. Food and Drug Administration's acceptance for filing of the New Drug Application (NDA) for DM-1796 for the management of postherpetic neuralgia (PHN), or pain after shingles.

29 Jun 2010