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Tamiflu in short supply, pharmacists compound doses for children suffering from the H1N1 flu virus

Community pharmacists have stepped up to meet the shortage of Tamiflu by compounding doses for children suffering from the H1N1 flu virus, but they are struggling with supply problems and insurance plans, according to the National Community Pharmacists Association.

3 Nov 2009

Crohn's disease drug market driven by TNF-alpha inhibitors Humira and Remicade

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the Crohn's disease drug market, the dominance of TNF-alpha inhibitors such as Abbott/Eisai's Humira and Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe's Remicade will continue over the next decade. Sales of Humira and Remicade, which accounted for more than three-quarters of the market in 2008, will continue to grow through 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

3 Nov 2009

Efficacy trial of the world's most clinically advanced malaria vaccine candidate underway

A pivotal efficacy trial of RTS,S, the world's most clinically advanced malaria vaccine candidate, is now underway in seven African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The trial, which is expected to involve up to 16,000 children, is on schedule, with more than 5,000 children already enrolled, researchers announced Tuesday at the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference.

3 Nov 2009

FDA update on BYETTA injection: Amylin Pharmaceuticals and Eli Lilly respond

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection.

3 Nov 2009

$New drug may help bone fractures heal more quickly after radiation exposure$

New drug may help bone fractures heal more quickly after radiation exposure

A drug currently under development by the University of Pittsburgh School of Medicine may help bone fractures heal more quickly after radiation exposure, according to a study by Pitt researchers. The study's results will be presented at 1 p.m. today during the American Society for Radiation Oncology (ASTRO) annual meeting in Chicago.

3 Nov 2009

FDA updates Byetta prescribing information following reports of kidney problems

The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

3 Nov 2009

Pregnant women tolerate the 2009 H1N1 flu vaccine, mount strong immune response

Healthy pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine, according to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

3 Nov 2009

Cipher Pharmaceuticals to defend alleged patent infringement of CIP-TRAMADOL ER

Cipher Pharmaceuticals Inc. today announced that Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. have filed a complaint against Cipher in the United States District Court for the Eastern District of Virginia, for alleged infringement of two U.S. patents. The action relates to Cipher's New Drug Application ("NDA") filed with the U.S. Food and Drug Administration ("FDA") for CIP TRAMADOL ER, the Company's extended-release tramadol product.

3 Nov 2009

Top-line results from Phase 3 linaclotide trial for chronic constipation

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC).

3 Nov 2009

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