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Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults.

18 Feb 2010

Sorafenib drug therapy can reduce the size of primary kidney tumors before surgery

More than 57,000 Americans face a diagnosis of kidney cancer each year. Now patients with advanced disease may soon have another treatment option. Physicians who conducted a pilot study at UNC Lineberger Comprehensive Cancer Center found that therapy before surgery with the drug sorafenib can reduce the size of large tumors and could be safely undertaken administered without adding significantly to the risks of surgery.

17 Feb 2010

Top health groups increased political spending in 2009

USA Today: "Pharmacists, optometrists and groups representing an array of medical specialists boosted their political giving in 2009, as Congress worked on health care legislation that would dramatically reshape their industry. ... Donations by the top 15 health care political action committees rose to $11.7 million in 2009, a nearly 14% increase from 2007, the most recent non-election year, according to a USA TODAY analysis of data compiled by CQ MoneyLine."

17 Feb 2010

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Talecris Biotherapeutics announced today that it has received approval from Health Canada for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more purified and concentrated version of PROLASTIN® produced using advances in manufacturing technology. A similar approval for PROLASTIN-C was granted by the U.S. Food and Drug Administration on October 17, 2009.

17 Feb 2010

IH Systems selects Robotic IV Automation Systems for cytotoxic drug preparation

Following the successful integration of RIVA (Robotic IV Automation System) - a self-contained unit for filling IV syringes and bags - into three healthcare institutions in 2009, and the announcements of several more sales for installation in 2010, medical device company Intelligent Hospital Systems has confirmed the sale of three additional RIVA systems for cytotoxic drug preparation in 2010.

17 Feb 2010

Pharmatek Laboratories meets DEA requirements for developing and manufacturing controlled substances

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has successfully met Drug Enforcement Agency (DEA) requirements to be registered for the development and manufacture of Schedule IV and V controlled substances.

17 Feb 2010

Menopause supplement to bring body back into balance

Whitemark Homes, Inc., is pleased to announce a satisfaction guaranteed top selling product line by Ribbon Naturals Corp., complete system Menopause Solutions. A solution for women who are dissatisfied with the results they receive from common, everyday menopause supplements. Now there is a supplement for menopause that brings the body back into balance.

17 Feb 2010

FDA approved cannabis medicines needed for veterans to relieve symptoms of PTSD

Cannabis Science Inc., an emerging pharmaceutical cannabis company, is reviewing interim results of its survey from over 1400 people, US military veterans and others who responded to our PTSD survey. The survey is still available for a limited time online on the www.cannabisscience.com website for all those who still wish to participate.

17 Feb 2010

Soligenix' LPM oral drug delivery technology receives Hong Kong patent

Soligenix, Inc., a late-stage biotechnology company, announced today that it has received a Hong Kong patent which addresses its Lipid Polymer Micelle (LPM™) technology for the improved oral delivery of drugs. The issued Hong Kong patent, HK 1071054, entitled "Stabilized Reverse Micelle Compositions and Uses Thereof" covers lipid structures (reverse micelles) that promote the intestinal absorption of peptides and other sensitive drugs that cannot otherwise be given orally.

17 Feb 2010

Cipher Pharmaceuticals announces fourth-quarter and fiscal year 2009 results

Cipher Pharmaceuticals Inc. today announced its financial and operational results for the fourth quarter and fiscal year ended December 31, 2009.

17 Feb 2010

UKONS publishes position statement on safe, effective use of oral anticancer medicines

A position statement from the UK Oncology Nursing Society (UKONS) on the safe, effective use of oral anticancer medicines was published online on 5 February 2010 by ecancermedicalscience.

17 Feb 2010

AHF to protest Merck’s Isentress pricing and policies at CROI

AIDS Healthcare Foundation (AHF) will host a protest Wednesday morning, February 17 at 8:00am targeting Merck and Co. Pharmaceuticals over the pricing and policies for its key HIV/AIDS drug, Isentress, the most expensive first-line AIDS treatment in the US, during the 17th Conference of Retroviruses and Opportunistic Infections (CROI) in San Francisco.

17 Feb 2010

AMAG's Feraheme use on the rise

BioTrends Research Group, Inc. released Wave 3 of its LaunchTrends®: Feraheme report, the third in a multi-phase syndicated market research project tracking the launch of AMAG's new IV iron product, Feraheme, through the first six months of product availability. Each wave of the report provides quantitative information from 50 unique Nephrologists and qualitative information from a subset of 15. The reports assess trial and use of Feraheme, obstacles to use, reasons to use, typical patient types, product perceptions, promotional efforts/messages, and product satisfaction.

17 Feb 2010

New book by 12 world-leading scientists calls for renewed approach to drug policy

Drug policy - or really, the way our society controls and provides interventions for both legal and illegal psychoactive substances - is one of those things that seems inherently controversial.

17 Feb 2010

Belatacept costimulation blocker can prevent rejection of new organs by the immune system

Initial results of a study conducted at 100 centers worldwide indicate that belatacept, a first-in-class costimulation blocker can prevent the immune system rejecting new organs. The results also suggest that it may provide similar patient and graft survival to cyclosporine but with fewer side effects and superior kidney function after 12 months. The study, published today in the American Journal of Transplantation, provides the first findings to come from BENEFIT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial).

17 Feb 2010

Research suggests scorpion venom could be an alternative to morphine painkiller

Scorpion venom is notoriously poisonous ― but it might be used as an alternative to dangerous and addictive painkillers like morphine, a Tel Aviv University researcher claims.

17 Feb 2010

Effectiveness of influenza vaccines in older people: No clear conclusions

Evidence for the safety and efficacy of influenza vaccines in the over 65s is poor, despite the fact that vaccination has been recommended for the prevention of influenza in older people for the past 40 years. These are the conclusions of a new Cochrane Systematic Review.

17 Feb 2010

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Obecure Ltd (http://www.obecure.com)., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., announced today the execution of a licensing and clinical supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group.

17 Feb 2010

Researchers use new strategy to develop cancer vaccines

Researchers at National Jewish Health and the University of Colorado School of Medicine have used a new strategy to develop cancer vaccines that are remarkably effective in mice. In the February 16 issue of the Proceedings of the National Academy of Sciences, Kimberly Jordan, PhD, Jill Slansky, PhD, and John Kappler, PhD, report that 100 percent of the mice vaccinated with a peptide they developed remained alive and tumor-free for at least 60 days after inoculation with colon cancer cells.

17 Feb 2010

ECR Pharmaceuticals to promote Urocit-K 15mEq tablets to primary care physicians

Hi-Tech Pharmacal Co., Inc. announced today that its branded marketing subsidiary, ECR Pharmaceuticals will promote Urocit®-K 15mEq, potassium citrate extended release tablets to primary care physicians beginning in April, 2010. Hi-Tech has a license agreement with Mission Pharmacal Company, which will promote the product to Urologists.

17 Feb 2010

Pharmaceutical News

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Sorafenib drug therapy can reduce the size of primary kidney tumors before surgery

Top health groups increased political spending in 2009

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

IH Systems selects Robotic IV Automation Systems for cytotoxic drug preparation

Pharmatek Laboratories meets DEA requirements for developing and manufacturing controlled substances

Menopause supplement to bring body back into balance

FDA approved cannabis medicines needed for veterans to relieve symptoms of PTSD

Soligenix' LPM oral drug delivery technology receives Hong Kong patent

Cipher Pharmaceuticals announces fourth-quarter and fiscal year 2009 results

UKONS publishes position statement on safe, effective use of oral anticancer medicines

AHF to protest Merck’s Isentress pricing and policies at CROI

AMAG's Feraheme use on the rise

New book by 12 world-leading scientists calls for renewed approach to drug policy

Belatacept costimulation blocker can prevent rejection of new organs by the immune system

Research suggests scorpion venom could be an alternative to morphine painkiller

Effectiveness of influenza vaccines in older people: No clear conclusions

Obecure enters into licensing and clinical supply agreement with Grunenthal's subsidiary for XR betahistine

Researchers use new strategy to develop cancer vaccines

ECR Pharmaceuticals to promote Urocit-K 15mEq tablets to primary care physicians

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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