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Further examination of key findings of Policy Innovation Memorandum on safety of world drug, vaccine supply

In this post on her blog, "The Garrett Update" -- the last of a series of posts examining the safety of drugs and vaccines -- Laurie Garrett, senior fellow for global health at the Council on Foreign Relations (CFR), further details the key findings of the CFR's Policy Innovation Memorandum No. 21, a six-point policy recommendation for the G8/20 that she authored, titled "Ensuring the Safety and Integrity of the World's Drug, Vaccine, and Medicines Supply."

19 May 2012

Studies show vitamin D may benefit cardiovascular, skin and metabolic disorders

The Endocrine Society's new scientific statement published online today represents the first comprehensive evaluation of both the basic and clinical evidence related to the non-skeletal effects of vitamin D. The statement addresses current research regarding the associations of vitamin D with immune function, hypertension, stroke, skin conditions and maternal/fetal health.

19 May 2012

JAT accepts five scientific articles co-authored by UCSD doctoral pharmacy students

The Millennium Research Institute (MRI), a nonprofit national research center formed in 2010, and the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego (UCSD) announced today five scientific articles co-authored by UCSD doctoral pharmacy students have been accepted by the Journal of Analytical Toxicology.

19 May 2012

Actavis receives FDA approval for Ropinirole ER Tablets

Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Ropinirole Extended-Release Tablets, 2mg, 4mg, 6mg, 8mg and 12mg, a generic equivalent to GlaxoSmithKline's Requip XL.

19 May 2012

Ocera’s Zysa receives CE Mark to treat IBS-d

Ocera Therapeutics Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary agents to treat gastrointestinal and liver diseases, announced today that it has received a CE Mark for Zysa (spherical carbon adsorbent, formerly AST-120) for the treatment of diarrhea predominant IBS (IBS-d), a condition affecting 10-15% of the Western world.

19 May 2012

PharMEDium to present enhanced labeling for ICU services at NTI and Critical Care Expo

Amy Langan, Vice President of Marketing and Business Development, announced that PharMEDium will highlight its enhanced labeling for sterile intravenous compounded ICU Services at the National Teaching Institute (NTI) and Critical Care Exposition, May 19-24, 2012 in Orlando, Florida.

19 May 2012

DCI receives FDA approval for PERTZYE NDA to treat EPI

Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for PERTZYE, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions.

19 May 2012

Two major reasons to monitor medication use in older patients with chronic pain

Ameritox, the nation's leader in pain medication monitoring, announced today the presentation of a peer-reviewed scientific poster titled "Patterns of Drug Use in the Older Chronic Pain Population" at the American Pain Society Annual Meeting.

18 May 2012

Health Canada approves Osiris’ Prochymal to treat acute GvHD in children

Osiris Therapeutics Inc. announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children.

18 May 2012

A decision in N.Y. case on access to abortion pills could impact presidential politics

Politico looks at how a court decision to open Plan B prescriptions to women under the age of 17 could put both President Barack Obama and GOP candidate Mitt Romney on the spot.

18 May 2012

Dr. Reddy's launches generic version of PLAVIX

Dr. Reddy's Laboratories announced today that it has launched CLOPIDOGREL TABLETS, USP 75 mg & 300 mg, a bioequivalent generic version of PLAVIX, in the U.S. market on May 18, 2012.

18 May 2012

UHN chooses Lexicomp as drug information resource for four hospitals

Wolters Kluwer Health, a leading global provider of information for healthcare professionals and students, announced today that Lexicomp has been selected by the University Health Network (UHN) as the drug information resource for its four hospitals located in Toronto, Canada.

18 May 2012

Medgenics’ EPODURE receives FDA clearance to proceed into clinical trials

Medgenics, Inc., developer of the novel Biopump technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the U.S. Food and Drug Administration to proceed with a Phase IIb clinical trial of EPODURE for the treatment of anemia in patients undergoing renal dialysis.

18 May 2012

Mylan receives final FDA approval for Clopidogrel 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 Clopidogrel Tablets USP, 75 mg and 300 mg.

18 May 2012

FDA approves Emergent’s BioThrax sBLA to treat anthrax disease

Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax (Anthrax Vaccine Adsorbed) to a three-dose primary series of intramuscular injections at 0, 1, and 6 months.

18 May 2012

Multiple companies receive FDA approval to sell generic Plavix

The U.S. Food and Drug Administration today approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.

18 May 2012

Generic versions of Lipitor to hit pharmacy shelves

In just days, a number of generic versions of Lipitor will hit pharmacy shelves. Pfizer's 180-day generic exclusivity agreement for the medication expires at the end of the month. That will bring a host of new generic alternatives, and potential confusion, to more than 3 million Americans looking to control their cholesterol and reduce the cost of their drug therapies.

17 May 2012

Apigenin effective against human breast cancer

Apigenin, a natural substance found in grocery store produce aisles, shows promise as a non-toxic treatment for an aggressive form of human breast cancer, following a new study at the University of Missouri.

17 May 2012

Immediate response required to curb spread of artemisinin-resistant malaria in Burma

In this Wall Street Journal opinion piece, Jay Winsten, associate dean at the Harvard School of Public Health, and Trish Stroman, a principal at the Boston Consulting Group, examine "the emergence in Southeast Asia of malarial parasites resistant to artemisinin -- the current gold-standard drug for treating the disease," writing it "poses grave new challenges."

17 May 2012

ACE2 molecule now protects major organs in diabetic patients

ACE2, a molecule that has been shown to prevent damage in the heart, is now proving to be protective of the major organs that are often damaged in diabetic patients.

17 May 2012