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National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in 2010.

2 Mar 2010

FDA grants approval to Spectral Diagnostics for pivotal trial of Toraymyxin

Spectral Diagnostics Inc., a company developing products for the treatment of sepsis, today announced that the U.S. Food and Drug Administration has granted Investigational Device Exemption (IDE) approval for Toraymyxin, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, allowing the Company to conduct a pivotal trial in the United States.

2 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

FDA approves CombinatoRx's NDA for Exalgo extended-release tablets

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration has approved the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

2 Mar 2010

Sanquin Blood Supply Foundation, Netherlands Vaccine Institute launch AmpVacs project to develop influenza A vaccine

Sanquin Blood Supply Foundation, the Netherlands Cancer Institute, and the Netherlands Vaccine Institute announce today the launch of their joint AmpVacs project aiming at the development of a broadly protective synthetic influenza A vaccine component that in combination with classical antibody-stimulating vaccines will induce protection against future influenza A threats.

2 Mar 2010

Prenatal cocaine exposure affects sustained attention and self-regulated behavior in children

Children exposed to cocaine in the womb face serious consequences from the drug, but fortunately not in certain critical physical and cognitive areas as previously believed, according to a new comprehensive review of research on the subject from scientists at the University of Maryland School of Medicine. When a pregnant woman uses cocaine, it can interrupt the flow of nutrients and oxygen to the baby, putting such children at risk for premature birth, low birth weight and many other problems.

2 Mar 2010

AstraZeneca drafts five principles for companies engaged in social media

AstraZeneca today asked the U.S. Food and Drug Administration (FDA) to adopt guidance that will enable AstraZeneca and others to fully engage in real-time, social media conversations that responsibly provide accurate, balanced information on medicines from a known, identifiable and reliable source.

2 Mar 2010

First-ever international Omega-3 Awareness Day

Omega-3 Awareness Day, the nonprofit is proud to announce its plans for the first-ever international awareness day scheduled on March 3rd, 2010 at the University of California, Irvine. Teams of world-renowned doctors founded by Carol A. Locke, MD are scheduled to speak on the science and health benefits of Omega-3 essential fatty acids from 3:00 p.m. to 6:30 p.m. PST in front of thousands of students at UCI.

2 Mar 2010

Clot-busting drug therapy after stroke beneficial for women

New research shows women who don't receive a clot-busting drug after a stroke fare worse than men who are not treated. The study is published in the March 2, 2010, print issue of Neurology®, the medical journal of the American Academy of Neurology.

2 Mar 2010

Future work may uncover links between insulin use and cancer risk, say researchers

The benefits of using insulin to treat diabetes far outweigh the risks, but a review just published online by IJCP, the International Journal of Clinical Practice, suggests that commonly used diabetes therapies may differ from each other when it comes to their influence on cancer risk.

2 Mar 2010

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza.

2 Mar 2010

Most strains of pandemic H1N1 flu virus resist Tamiflu, say scientists

If the behavior of the seasonal form of the H1N1 influenza virus is any indication, scientists say that chances are good that most strains of the pandemic H1N1 flu virus will become resistant to Tamiflu, the main drug stockpiled for use against it.

2 Mar 2010

Scientists show omega-3 fatty acid and its derivatives kill neuroblastoma cancer cells

The next treatment for cancer might come from fish says a new research report published in the March 2010 print edition of the FASEB Journal (http://www.fasebj.org). In the report, scientists show that the omega-3 fatty acid, "docosahexaenoic acid" or "DHA," and its derivatives in the body kill neuroblastoma cancer cells.

2 Mar 2010

My Little Miracle Essay Contest: Winners to receive education fund prizes to support their children's future

If you are a parent who has conceived using Ferring Pharmaceuticals' fertility products, you can win a $10,000 education fund to support your child's future. Two other education fund prizes will also be awarded.

2 Mar 2010

Merck's Isentress HIV/AIDS drug pricing: CalSTRS and CalPERS express concern

Today AIDS Healthcare Foundation (AHF) announced that the two largest public pension funds in the nation, the California State Teachers' Retirement System (CalSTRS) and the California Public Employees’ Retirement System (CalPERS), have sent letters to Merck and Co. Pharmaceuticals expressing concern over the company’s pricing for its key HIV/AIDS drug, Isentress—now the most expensive first-line AIDS treatment in the U.S.

2 Mar 2010

Canyon Pharmaceuticals announces the availability of Iprivask inhibitor for prevention of DVT

Canyon PharmaceuticalsTM (www.canyonpharma.com) today announced the availability of Iprivask (desirudin for injection), the first direct thrombin inhibitor (DTI) approved in the United States by the Food and Drug Administration for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing elective hip replacement surgery.

2 Mar 2010

Long-time cannabis use linked to psychosis-related outcomes

Young adults who have used cannabis or marijuana for a longer period of time appear more likely to have hallucinations or delusions or to meet criteria for psychosis, according to a report posted online today that will appear in the May print issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

2 Mar 2010

GTC Biotherapeutics achieves high-level production of TG20 monoclonal antibody

GTC Biotherapeutics, Inc. announced that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of the LFB-GTC joint venture.

2 Mar 2010

Belatacept Biologics License Application: FDA drug advisory committee recommends approval

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients.

2 Mar 2010

FDA's ODAC to review CTI's pixantrone NDA on March 22, 2010

Cell Therapeutics, Inc. announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New Drug Application ("NDA") for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL") on March 22, 2010.

2 Mar 2010

Pharmaceutical News

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

FDA grants approval to Spectral Diagnostics for pivotal trial of Toraymyxin

InterMune seeks European marketing approval for pirfenidone

FDA approves CombinatoRx's NDA for Exalgo extended-release tablets

Sanquin Blood Supply Foundation, Netherlands Vaccine Institute launch AmpVacs project to develop influenza A vaccine

Prenatal cocaine exposure affects sustained attention and self-regulated behavior in children

AstraZeneca drafts five principles for companies engaged in social media

First-ever international Omega-3 Awareness Day

Clot-busting drug therapy after stroke beneficial for women

Future work may uncover links between insulin use and cancer risk, say researchers

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Most strains of pandemic H1N1 flu virus resist Tamiflu, say scientists

Scientists show omega-3 fatty acid and its derivatives kill neuroblastoma cancer cells

My Little Miracle Essay Contest: Winners to receive education fund prizes to support their children's future

Merck's Isentress HIV/AIDS drug pricing: CalSTRS and CalPERS express concern

Canyon Pharmaceuticals announces the availability of Iprivask inhibitor for prevention of DVT

Long-time cannabis use linked to psychosis-related outcomes

GTC Biotherapeutics achieves high-level production of TG20 monoclonal antibody

Belatacept Biologics License Application: FDA drug advisory committee recommends approval

FDA's ODAC to review CTI's pixantrone NDA on March 22, 2010

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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