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Cardium Therapeutics to seek FDA marketing clearance for ExcellagenXL

Cardium Therapeutics today announced plans to submit a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its ExcellagenXL(TM) product candidate.

3 Nov 2009

Malaria conference begins in Nairobi, will highlight outlook for RTS,S experimental malaria vaccine

The 5th Multilateral Initiative on Malaria (MIM) Pan-African Conference "kicked off in Nairobi late Sunday with a call for substantial and sustained support for research to guide evidence-based policies and the development of new malaria tools, which together could save countless lives," Xinhua reports (11/2).

2 Nov 2009

Shortage of Tamiflu in liquid form contributes to dosage errors

Two pediatric patients in Pennsylvania hospitals received overdoses of the drug Tamiflu to treat their flu symptoms because of unawareness among staff as to the concentration of the drug given in an alternative liquid form. Both children were unharmed as a result of the errors, but details of the near misses have been published in a supplementary Pennsylvania Patient Safety Advisory to raise awareness of the issue.

2 Nov 2009

Sanofi Pasteur presents Menactra vaccine safety data at the IDSA

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, presented Safety of a Quadrivalent (A,C,Y,W-135) Meningococcal Vaccine When Given to Infants with Other Pediatric Vaccines at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) this past weekend.

2 Nov 2009

Study of combination therapy versus monotherapy for pulmonary arterial hypertension

Gilead Sciences, Inc., in collaboration with GlaxoSmithKline (GSK), today announced plans for an international, event-driven (morbidity and mortality) clinical trial to study combination therapy versus monotherapy in a first-line treatment setting for pulmonary arterial hypertension (PAH).

2 Nov 2009

FDA issues a Complete Response Letter for GTx' toremifene NDA

GTx, Inc. today announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

2 Nov 2009

Kinetic Concepts receives approval from MHLW in Japan to sell its V.A.C. Therapy System

Kinetic Concepts, Inc. announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted final regulatory approval for KCI to market and sell its innovative V.A.C.® Therapy System in the country.

2 Nov 2009

Canadian programs underscore evidence of PEGETRON's positive outcomes in treating HCV infection

Results from two significant Canadian studies underscore the growing scientific evidence of PEGETRON's positive outcomes in the treatment of chronic hepatitis C virus (HCV) infection. Canadian investigators across the country collaborated to generate and analyze clinical data from the Canadian PEGETRON POWeR (Prospective Optimal Weight-based Dosing Response) and REDIPEN programs, which were presented at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston on November 1, 2009.

2 Nov 2009

Sosei and ASKA Pharmaceuticals sign distribution agreement

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, has entered into a definitive distribution agreement with ASKA Pharmaceuticals Co., Ltd. ("ASKA", TSE First Section Index: 4514) for the commercialisation of the emergency contraceptive pill SOH-075 (NorLevo(R)).

2 Nov 2009

Unexpected consequences emerge in patients who are prescribed PPI medications for reflux diseases

Despite being highly effective and beneficial for many patients, unexpected consequences are emerging in patients who are prescribed proton pump inhibitors (PPIs) for reflux diseases. Physicians are warned to monitor these effects and prescribe these medications carefully, according to a new commentary published in the November 2009 issue of Otolaryngology - Head and Neck Surgery.

2 Nov 2009

ACTwatch data indicates low accessibility of artemisinin combination therapy

ACTwatch, a research project led by PSI, in collaboration with the London School of Hygiene and Tropical Medicine, released evidence today that indicates that artemisinin combination therapy, the most effective medicines for treating malaria, continue to have a significantly low presence on the market among populations considered to be most at risk.

2 Nov 2009

Switching to new immunosuppressant drug may reduce skin cancer after kidney transplantation

Switching to a newer type of immunosuppressant drug may reduce the high rate of skin cancer after kidney transplantation, according to research being presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, CA.

2 Nov 2009

Amylin and Takeda to develop and commercialize pharmaceutical products for obesity

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that they have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications.

2 Nov 2009

Multicenter study finds AMD patients can benefit from cataract surgery

This month's Ophthalmology, the journal of the American Academy of Ophthalmology (Academy) reports on a national study that finds cataract surgery is likely to benefit patients with age-related macular degeneration (AMD) at all stages of the disease, on a clinical trial showing that the steroid triamcinolone may be effective in advanced diabetic macular edema (DME) patients when standard treatment fails, and on the public's use of two Academy-sponsored online eye health forums.

2 Nov 2009

London Genetics enters an intensive partnering programme

London Genetics Limited, an expert in the use of pharmacogenetics in clinical drug discovery and development, has entered an intensive partnering programme following on from its successful pharmacogenetic conference in September.

31 Oct 2009

Performance-focused metrics supporting forward-looking decision making critical for drug companies

Top Performing Drug Developers Are Merging Operational And Strategic Objectives, According To Tufts Center For The Study Of Drug Development

31 Oct 2009

New report on the global addiction pharmacotherapeutic market

The world market for medicines that treat addiction disorders is currently valued at US$3.2bn is set to increase by 19% by 2016 to $3.8bn, forecasts a new market report from URCH Publishing.

31 Oct 2009

New study results of INTUNIV presented at a major psychiatric medical meeting

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended Release Tablets, at a major psychiatric medical meeting today.

31 Oct 2009

Exposure to mercury-based preservative in vaccines is minimal, says researchers

The injectable, multi-dose H1N1 vaccine contains the mercury-based preservative thimerosol to reduce risks of bacterial contamination. The presence of thimerosol has once again raised concerns whether there are risks posed to children when the tiny amount of mercury contained in thimerosol is included in a vaccine.

31 Oct 2009

Requests to compound liquid Tamiflu have steadily increased over the past couple of weeks

There has been a lot of information about the importance of taking preventative measures against H1N1, primarily through vaccination. But what if a person has already contracted H1N1? What if that person is a young child?

31 Oct 2009

Pharmaceutical News

Cardium Therapeutics to seek FDA marketing clearance for ExcellagenXL

Malaria conference begins in Nairobi, will highlight outlook for RTS,S experimental malaria vaccine

Shortage of Tamiflu in liquid form contributes to dosage errors

Sanofi Pasteur presents Menactra vaccine safety data at the IDSA

Study of combination therapy versus monotherapy for pulmonary arterial hypertension

FDA issues a Complete Response Letter for GTx' toremifene NDA

Kinetic Concepts receives approval from MHLW in Japan to sell its V.A.C. Therapy System

Canadian programs underscore evidence of PEGETRON's positive outcomes in treating HCV infection

Sosei and ASKA Pharmaceuticals sign distribution agreement

Unexpected consequences emerge in patients who are prescribed PPI medications for reflux diseases

ACTwatch data indicates low accessibility of artemisinin combination therapy

Switching to new immunosuppressant drug may reduce skin cancer after kidney transplantation

Amylin and Takeda to develop and commercialize pharmaceutical products for obesity

Multicenter study finds AMD patients can benefit from cataract surgery

London Genetics enters an intensive partnering programme

Performance-focused metrics supporting forward-looking decision making critical for drug companies

New report on the global addiction pharmacotherapeutic market

New study results of INTUNIV presented at a major psychiatric medical meeting

Exposure to mercury-based preservative in vaccines is minimal, says researchers

Requests to compound liquid Tamiflu have steadily increased over the past couple of weeks

Redefining control and consistency in anaerobic microbiome workflows

AI in Healthcare: How generative tools are transforming clinical practice

The future of automation: Machine learning–driven hepatocyte and organoid counting

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