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Experts gathered for UNAIDS, WHO meeting recommend follow-up studies of ARV-containing microbicide gel start soon

Experts gathered at a joint meeting of UNAIDS and the WHO last week called for two additional clinical trials to test the effectiveness and safety of a microbicide vaginal gel containing the antiretroviral tenofovir, which previous studies have shown reduces the risk of HIV transmission in women who used it before and after sex by 39 percent, PANA/Afrique en ligne reports (9/5).

8 Sep 2010

Oxygen Biotherapeutics offers traumatic brain injury trials for Israeli soldiers

Oxygen Biotherapeutics, Inc., a development stage biomedical company focused on developing oxygen-rich intravenous and topical products, today announced that Israeli soldiers who suffer severe traumatic brain injury (TBI) can be enrolled in the company's Phase II-b STOP-TBI trials at clinical sites in Israel.

8 Sep 2010

La Jolla Pharmaceutical seeks clinical product for lupus treatment

La Jolla Pharmaceutical Company provided an update today that the Company is actively seeking and evaluating potential pharmaceutical products for in-licensing or acquisition and has engaged consultants to determine whether there is any potential for the further development of Riquent for the treatment of lupus.

8 Sep 2010

Global Fund investigates allegations that donated malaria drugs were stolen, resold in some African countries

After recent research found that some donated malaria drugs are being stolen and sold commercially in several African countries, the Global Fund to Fight AIDS, Tuberculosis and Malaria Communications Director Joe Liden said the group is looking into the situation "in a number of countries," PBS' NewsHour's blog, "The Rundown" reports.

8 Sep 2010

Forest Laboratories' ceftaroline fosamil receives FDA Advisory Committee approval for CABP and cSSSI

Forest Laboratories, Inc. announced that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted 21 - 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 - 0 in favor of approval for complicated skin and skin structure infections (cSSSI).

8 Sep 2010

Fluctuation in PCV-7 vaccine dosing time increases pneumococcal serotype 19A strains: Study

Infants who received heptavalent pneumococcal conjugate vaccination (PCV-7) at 2, 4, and 11 months were more likely than unvaccinated controls to have nasopharyngeal (in the nasal passages and upper part of the throat behind the nose) acquisition of pneumococcal serotype 19A, a leading cause of respiratory pneumococcal disease, according to a study in the September 8 issue of JAMA.

8 Sep 2010

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

Pharmaceutical News

Experts gathered for UNAIDS, WHO meeting recommend follow-up studies of ARV-containing microbicide gel start soon

Oxygen Biotherapeutics offers traumatic brain injury trials for Israeli soldiers

La Jolla Pharmaceutical seeks clinical product for lupus treatment

Global Fund investigates allegations that donated malaria drugs were stolen, resold in some African countries

Forest Laboratories' ceftaroline fosamil receives FDA Advisory Committee approval for CABP and cSSSI

Fluctuation in PCV-7 vaccine dosing time increases pneumococcal serotype 19A strains: Study

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

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