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BMJ investigation raises concern on rosiglitazone diabetes drug safety

A BMJ investigation into the top-selling diabetes drug rosiglitazone (Avandia) raises concerns about its safety and the whole system by which drugs are evaluated, regulated, and promoted around the world.

8 Sep 2010

CDC ramps up production of new three-in-one flu vaccine

Health officials say that there will be plenty of flu vaccine available this year, now that the H1N1 pandemic has ended, The Washington Post reports. "The World Health Organization declared an end to the pandemic last month, based on indications that the H1N1 flu was transitioning to a more seasonal virus. Unlike last year, when there was one vaccine for H1N1 flu and another for seasonal flu, this year's vaccine is a 'three-in-one' that includes protection against H1N1 as well as two other strains."

8 Sep 2010

Alzheimer's disease drug market to increase from $4.3 billion to $13.3 billion in 2019: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to the emergence of new agents that have the potential to affect disease progression, the Alzheimer's disease drug market will more than triple, from $4.3 billion in 2009 to $13.3 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

8 Sep 2010

Watson Laboratories receives FDA approval for Zarah tablets

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Zarah (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin.

7 Sep 2010

Oragenics launches oral care probiotic products through GNC Stores

Florida-based biopharmaceutical company Oragenics, Inc. announced today that its oral care probiotic EvoraPlus® is now expected to be available at corporate-owned GNC stores nationwide. In addition, GNC has included Oragenics' oral care probiotic for children, EvoraKids™, in its concept stores and on GNC.com.

7 Sep 2010

Bayer Consumer Care introduces One A Day Menopause Formula to help address hot flashes

September is Menopause Awareness Month and women starting the transition into menopause have more information and resources than ever to start taking control of their menopause symptoms. Bayer Consumer Care now introduces One A Day® Menopause Formula, a complete multivitamin with soy isoflavones to help address hot flashes and mild mood changes.

7 Sep 2010

Somaxon's Silenor now commercially available in U.S.

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that Silenor® (doxepin) now is commercially available by prescription in the United States. Somaxon has implemented a wholesale and retail stocking program to disseminate Silenor 3 mg and 6 mg dosepacks to pharmacies across the United States. Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

7 Sep 2010

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold.

7 Sep 2010

Bend Research expands hot-melt extrusion pharmaceutical manufacturing capabilities

Bend Research Inc., a leading independent drug-formulation development and manufacturing company, announced today that it is expanding its pharmaceutical manufacturing capabilities for hot-melt extrusion.

7 Sep 2010

DSM Pharma launches InnoSyn route scouting services for pharmaceutical customers

DSM Pharma Chemicals, a business unit of DSM Pharmaceutical Products, today announced the launch of InnoSyn™ route scouting services. In response to the increasing interest of pharmaceutical customers to outsource the development of robust low-cost manufacturing routes, DSM is offering focused and flexible stand alone route scouting services.

7 Sep 2010

Scientists urge government to set target effectiveness for newly approved antibiotics

The United States must focus on conserving the use of antibacterial drugs, or face a public health crisis from rapidly rising rates of antibiotic-resistant infections, according to an analysis out today.

7 Sep 2010

Almost half of all Americans use prescription drugs each month

Nearly half of all Americans used at least one prescription drug per month in 2008, according to a study by the Centers for Disease Control and Prevention, Bloomberg reports. That's a 10 percent increase over the preceding decade. Over that time, yearly spending by Americans on drugs doubled to $234 billion. "The two biggest-sellers last year were Pfizer Inc.'s Lipitor for high cholesterol and Bristol-Myers Squibb Co.'s clot-buster, Plavix.

4 Sep 2010

FDA approves IDE study to evaluate HeartWare Ventricular Assist System

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a second allotment of 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

4 Sep 2010

Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.

3 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Celldex Therapeutics regains worldwide rights to commercialize rindopepimut therapeutic cancer vaccine

Celldex Therapeutics, Inc. announced today it will regain full worldwide rights to develop and commercialize rindopepimut (CDX-110), effective November 1, 2010.

3 Sep 2010

Regional Director of WHO Africa warns of impact global financial situation will have on health systems, MDGs

Regional Director of WHO for Africa Luis Sambo discussed during the 60th session of the Africa Committee of the WHO how the global economic situation could impact funding for health programs in Africa and the ability for countries to reach U.N. Millennium Development Goal targets, PANA/Afrique en ligne reports.

3 Sep 2010

EQP program helps healthcare professionals identify quality of dietary supplements

Not all supplements are created equally but Emerson Ecologics, the largest provider of dietary supplements and services to healthcare professionals, is taking aggressive steps to make it more clear to healthcare professionals and their patients which manufacturers to trust when it comes to a supplement's purity, identity and potency.

3 Sep 2010

New peer-reviewed study on chemopreventive effects of Protandim

LifeVantage Corporation, the maker of Protandim®, a clinically proven, science-based therapy for oxidative stress, announced today that a new peer-reviewed study involving Protandim® was published in the scientific journal PLoS ONE. The study, conducted by researchers at Louisiana State University, examined the biochemical mechanisms that underlie the ability of Protandim® to suppress tumors in mice. That ability was previously demonstrated by the authors in a study involving a mouse two-stage model of chemically-induced skin cancer.

3 Sep 2010

Dilemmas created for healthcare professionals by medicinal use of cannabis

Nurses have a responsibility to respect and support patients who use cannabis for medicinal purposes, but must stay within the law and follow professional guidance at all times, according to a research review in the September issue of the Journal of Clinical Nursing.

3 Sep 2010

Pharmaceutical News

BMJ investigation raises concern on rosiglitazone diabetes drug safety

CDC ramps up production of new three-in-one flu vaccine

Alzheimer's disease drug market to increase from $4.3 billion to $13.3 billion in 2019: Report

Watson Laboratories receives FDA approval for Zarah tablets

Oragenics launches oral care probiotic products through GNC Stores

Bayer Consumer Care introduces One A Day Menopause Formula to help address hot flashes

Somaxon's Silenor now commercially available in U.S.

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Bend Research expands hot-melt extrusion pharmaceutical manufacturing capabilities

DSM Pharma launches InnoSyn route scouting services for pharmaceutical customers

Scientists urge government to set target effectiveness for newly approved antibiotics

Almost half of all Americans use prescription drugs each month

FDA approves IDE study to evaluate HeartWare Ventricular Assist System

Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celldex Therapeutics regains worldwide rights to commercialize rindopepimut therapeutic cancer vaccine

Regional Director of WHO Africa warns of impact global financial situation will have on health systems, MDGs

EQP program helps healthcare professionals identify quality of dietary supplements

New peer-reviewed study on chemopreventive effects of Protandim

Dilemmas created for healthcare professionals by medicinal use of cannabis

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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