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FDA issues a Complete Response Letter for Human Genome Sciences' raxibacumab BLA

Human Genome Sciences, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.

16 Nov 2009

Genta announces Phase 3 trial results of Genasense

Genta Incorporated today announced preliminary results from AGENDA, the Company’s Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. AGENDA is a randomized, double-blind, placebo-controlled trial of dacarbazine (DTIC) administered with or without Genasense® in patients who have not previously received chemotherapy.

16 Nov 2009

Macomb County targets pregnant women and health care workers for its next two H1N1 vaccine clinics

Pregnant women, their families and health care workers are being targeted by the Macomb County Health Department for its next two H1N1 vaccine clinics, department officials announced today. All are being offered at no charge.

16 Nov 2009

Inovio Biomedical reports financial results for the three and nine months ended September 30, 2009

Inovio Biomedical Corporation today reported financial results for the three and nine months ended September 30, 2009.

16 Nov 2009

Foreign particles in some products filled at Genzyme's Allston Landing facility, "Dear Doctor" letter issued

BioMarin Pharmaceutical Inc. announced today that Genzyme notified the company that, in rare circumstances, it has detected foreign particles in some products filled at the Allston Landing facility. To ensure that patients are not exposed to foreign particles during product administration, Genzyme has issued a "Dear Doctor" letter to all physicians treating patients with enzyme replacement products that it markets, including Aldurazyme.

16 Nov 2009

Ketamine use increasing faster than any other drug in the UK, shows research

The first ever large-scale, longitudinal study of ketamine users has been published online today in the journal Addiction. With Ketamine (K, Special K) use increasing faster than any other drug in the UK (British Crime Survey, 2008) this research showing the consequences of repeated ketamine use provides valuable information for users and addiction professionals alike.

16 Nov 2009

Effect of niacin or ezetimibe added to chronic statin therapy on carotid intima media thickness: Study

In combination with statins, adding a medication that raises high-density lipoprotein (HDL) cholesterol was more effective in reversing artery wall plaque buildup and in reducing heart disease risk than adding a drug that lowers low-density lipoprotein (LDL) cholesterol, researchers reported today at the American Heart Association Scientific Sessions 2009.

16 Nov 2009

Proteo's Elafin recommended for orphan drug status in Europe

The Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) has issued a recommendation granting orphan drug status to Proteo's drug candidate Elafin for the treatment of esophagus carcinoma. The orphan drug status will become effective upon ratification of this recommendation by the European Commission.

16 Nov 2009

Normal synaptic activity in nerve cells protects brain from Huntington's disease

Investigators at Burnham Institute for Medical Research (Burnham), the University of British Columbia's Centre for Molecular Medicine and Therapeutics and the University of California, San Diego have found that normal synaptic activity in nerve cells (the electrical activity in the brain that allows nerve cells to communicate with one another) protects the brain from the misfolded proteins associated with Huntington's disease.

16 Nov 2009

Potential of the European Biomarker Analysis Market to be the focus at upcoming Analyst Briefing

The "omics" revolution of the last decade has ensured that the field of biomarker research will test the frontiers of biomedical research in the coming years. New biomarkers are discovered each day and this rapid development promises excellent growth potential for the biomarker analysis market. However, due to various challenges faced in biomarker validation and assay development, there is a huge lag between the time that a biomarker is discovered in the laboratory and the time it is actually commercialized.

16 Nov 2009

Some combination drug therapies are counter-productive

Combination drug therapy has become a staple for treating many infections. For instance, doctors treat extensively drug resistant forms of tuberculosis with one drug that breaks down the pathogen's protective barriers and opens the door for another to deliver the deathblow.

16 Nov 2009

Department of Health to conduct statewide clinics to administer free H1N1 vaccine

The Department of Health today announced it will conduct statewide clinics from Nov. 20-22 to administer free H1N1 vaccine to individuals in the recommended target groups that have not had previous access to the vaccine.

16 Nov 2009

New reversible oral anti-platelet medication had fewer cardiac events in heart attack patients

Acutely ill heart attack patients who received both aspirin and a new reversible oral anti-platelet medication had fewer cardiac events than patients on aspirin and the most commonly used, irreversible anti-platelet drug, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

16 Nov 2009

Chronic pain patients with depression three times more likely to receive opioid medications

Chronic pain patients with a history of depression are three times more likely to receive long-term prescriptions for opioid medications like Vicodin compared to pain patients who do not suffer from depression, according to new research.

16 Nov 2009

TIME examines efforts to combat malaria resistance along Thai-Cambodia border

TIME reports on evidence along the Thai-Cambodia border that the malaria parasite is gaining resistance to artemisinin - "the only remaining effective drug in the world's arsenal against malaria's most deadly strain."

16 Nov 2009

Merck to market and develop cardiovascular medicines for a range of cardiovascular disorders

Following the completion of its merger with Schering-Plough, Merck today confirms and underscores its commitment to marketing and developing cardiovascular medicines for a range of cardiovascular disorders.

16 Nov 2009

Phase I clinical study for ETC-1002 commenced

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced that the company has initiated a Phase I clinical study for ETC-1002, the company's novel small molecule compound designed to beneficially regulate the levels of plasma lipids and lipoproteins.

16 Nov 2009

Priority Review of the NDA for intravenous acetaminophen extended by three months

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months.

15 Nov 2009

$1.2 million federal grant to University of Illinois for botanical dietary supplements research

The University of Illinois at Chicago has received a two-year, $1.2 million federal grant to develop a new method to identify the contents of botanical dietary supplements and how they work.

13 Nov 2009

Medicare Part D program exceeds expectations, majority of seniors approve their plan and coverage

Almost four years after the Medicare Part D prescription drug program went into effect, an overwhelming majority (88 percent) of America's seniors approve of their individual plan and coverage. In a national survey released this morning by the nonpartisan Medicare Today Coalition, 95 percent of seniors who used their plan and received prescriptions over the past year also reported that their plan has worked well, while 85 percent continue to find their monthly premium to be affordable.

13 Nov 2009

Pharmaceutical News

FDA issues a Complete Response Letter for Human Genome Sciences' raxibacumab BLA

Genta announces Phase 3 trial results of Genasense

Macomb County targets pregnant women and health care workers for its next two H1N1 vaccine clinics

Inovio Biomedical reports financial results for the three and nine months ended September 30, 2009

Foreign particles in some products filled at Genzyme's Allston Landing facility, "Dear Doctor" letter issued

Ketamine use increasing faster than any other drug in the UK, shows research

Effect of niacin or ezetimibe added to chronic statin therapy on carotid intima media thickness: Study

Proteo's Elafin recommended for orphan drug status in Europe

Normal synaptic activity in nerve cells protects brain from Huntington's disease

Potential of the European Biomarker Analysis Market to be the focus at upcoming Analyst Briefing

Some combination drug therapies are counter-productive

Department of Health to conduct statewide clinics to administer free H1N1 vaccine

New reversible oral anti-platelet medication had fewer cardiac events in heart attack patients

Chronic pain patients with depression three times more likely to receive opioid medications

TIME examines efforts to combat malaria resistance along Thai-Cambodia border

Merck to market and develop cardiovascular medicines for a range of cardiovascular disorders

Phase I clinical study for ETC-1002 commenced

Priority Review of the NDA for intravenous acetaminophen extended by three months

$1.2 million federal grant to University of Illinois for botanical dietary supplements research

Medicare Part D program exceeds expectations, majority of seniors approve their plan and coverage

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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