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FDA issues Complete Response Letter for Teva's Neutroval BLA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Application (BLA) for Neutroval™ (granulocyte colony-stimulating factor) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

1 Oct 2010

First nationwide Safe Medication Disposal Program launched

Walgreens has launched the first ongoing, nationwide Safe Medication Disposal Program, a safe and environmentally responsible way to dispose of unused or expired medications.

1 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

HIV/AIDS researchers, government officials track progress, forecast challenges for HIV vaccine development

More than 1,000 researchers, government officials and advocates are gathering in Atlanta this week to discuss the progress and future challenges in the development of a vaccine that protects against HIV, FierceVaccines reports (Carroll, 9/29). The AIDS Vaccine 2010 meeting, which kicked off Tuesday, will run through Friday, according to the website for the meeting (undated).

1 Oct 2010

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

Researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS).

1 Oct 2010

APhA urges consumers to discuss proper medication usage with pharmacists

In honor of American Pharmacists Month, the American Pharmacists Association (APhA) encourages consumers to hold an open dialogue with their pharmacists about a growing problem in the United States, the proper usage of and adherence to medications.

1 Oct 2010

Biologics can achieve great success - but at great cost

The Wall Street Journal's Health Blog: Insurers want to know why biologic drugs are so expensive. "UnitedHealth Group's Prescription Solutions unit hosted a roundtable this morning in midtown Manhattan focusing on a topic that's hot right now: the rocketing growth of spending on biologic drugs.

1 Oct 2010

Progressive Medical updates 2010 Drug Spend Analysis

Progressive Medical, Inc. announced today the release of a mid-year update to its 2010 Drug Spend Analysis. This report, which supplements the report released in April, provides clients with an update in workers' compensation medication spending from January 2010 through June 2010 and key factors that affect future expenditures, including inflation, utilization and product mix.

30 Sep 2010

Tengion presents Neo-Kidney Augment development program at ISCT Symposium

Tengion, Inc. presented new research data yesterday in a podium presentation at the 2nd Annual Symposium on Stem Cell Translation of the International Society for Cellular Therapy (ISCT) in San Francisco. The presentation highlighted new results from Tengion's Neo-Kidney Augment development program demonstrating success with an autologous cellular therapy approach to kidney regeneration in a rodent model of obesity, diabetes and hypertension.

30 Sep 2010

Canadian Cancer Society alarmed by government inaction to establish national catastrophic drug insurance program

A large majority of Canadians - 85 per cent - say if they were diagnosed with cancer the cost of drugs would have a negative impact on their personal finances, according to poll results released today by the Canadian Cancer Society.

30 Sep 2010

Genotoxic impurities in prescription drugs

Drug manufacturers have been adjusting to strict new government standards that limit the amount of potentially harmful impurities in medicine, according to the cover story of the current issue of Chemical & Engineering News (C&EN), ACS' weekly newsmagazine. The impurities are "genotoxic," capable of damaging the DNA in genes.

30 Sep 2010

Dyax, CMIC enter agreement to develop and commercialize DX-88 for HAE treatment

Dyax Corp. and CMIC Co., Ltd, announced today an agreement to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other angioedema indications in Japan.

30 Sep 2010

Circassia announces advancement in T-cell allergy vaccines development

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that it has further advanced the clinical development of three of its leading T-cell allergy vaccines.

30 Sep 2010

Malaria experts focus on RTS, S as Malaria Vaccines for the World Conference begins

Scientists and physicians from around the world gathered in Washington, D.C. on Tuesday for the start of the second Malaria Vaccines for the World Conference, SAPA/News24 reports.

30 Sep 2010

Access Pharmaceuticals reports significant progress in Cobalamin-targeted drug-delivery program for siRNA therapies

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced today that it has made significant progress with its proprietary Cobalamin-targeted drug-delivery program for siRNA therapies.

30 Sep 2010

Research shows dexamethasone treatment effective for bacterial meningitis

New research shows that an intravenous (IV) treatment may cut a person's risk of dying from bacterial meningitis. The research is published in the September 29, 2010, online issue of Neurology, the medical journal of the American Academy of Neurology. The treatment is called dexamethasone.

30 Sep 2010

Increase in sales of new antidepressants not linked to decline in suicide rate

Many researchers have studied the relationship between the increase in sales of new antidepressants in recent decades and a simultaneous decline in the suicide rate. In a study based on figures from the Nordic countries, researchers at the Norwegian Institute of Public Health found no evidence that increased sales of the new medicines could be linked to a lower suicide rate. The researchers also did not find any relationship between reduced sales of the older and more toxic antidepressants and a reduction in suicide rates.

30 Sep 2010

Merck's ROTATEQ vaccine receives Prix Galien USA 2010 Award for Best Biotechnology Product

ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent), Merck's vaccine for rotavirus gastroenteritis in infants and children, received the Prix Galien USA 2010 Award for Best Biotechnology Product, Merck announced today.

30 Sep 2010

NABP seeks to educate public about rogue Internet drug outlets, counterfeit medications

Earlier this year, the National Association of Boards of Pharmacy® (NABP®) was introduced to the AWARxE campaign, which was created and implemented by the Minnesota Pharmacists Foundation in 2007. Moved by the power of the campaign, NABP obtained the AWARxE program so that its message could be shared on a national level.

30 Sep 2010

FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

Progenics Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA), along with the European Medicines Agency (EMA) of the European Union (E.U.) and Health Canada, the Canadian Regulatory Agency, have each approved single-use, pre-filled syringes of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for use in their respective territories. These pre-filled syringes provide a simplified dosing option for the treatment of opioid-induced constipation (OIC) in palliative-care patients with advanced illness.

30 Sep 2010

Pharmaceutical News

FDA issues Complete Response Letter for Teva's Neutroval BLA

First nationwide Safe Medication Disposal Program launched

FDA takes action against unapproved single-ingredient oral colchicine

HIV/AIDS researchers, government officials track progress, forecast challenges for HIV vaccine development

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

APhA urges consumers to discuss proper medication usage with pharmacists

Biologics can achieve great success - but at great cost

Progressive Medical updates 2010 Drug Spend Analysis

Tengion presents Neo-Kidney Augment development program at ISCT Symposium

Canadian Cancer Society alarmed by government inaction to establish national catastrophic drug insurance program

Genotoxic impurities in prescription drugs

Dyax, CMIC enter agreement to develop and commercialize DX-88 for HAE treatment

Circassia announces advancement in T-cell allergy vaccines development

Malaria experts focus on RTS, S as Malaria Vaccines for the World Conference begins

Access Pharmaceuticals reports significant progress in Cobalamin-targeted drug-delivery program for siRNA therapies

Research shows dexamethasone treatment effective for bacterial meningitis

Increase in sales of new antidepressants not linked to decline in suicide rate

Merck's ROTATEQ vaccine receives Prix Galien USA 2010 Award for Best Biotechnology Product

NABP seeks to educate public about rogue Internet drug outlets, counterfeit medications

FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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