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Celerion completes Clean Room, pharmacist certification to comply with USP 797 guidelines

Celerion, the premier provider of innovative early stage drug development solutions, announces the completion of a Clean Room and pharmacist certification to comply with USP 797 guidelines.

3 Mar 2011

CTI meets officials of FDA's OND to support pixantrone NDA

Cell Therapeutics, Inc. today announced that it has met with officials of the FDA's Office of New Drugs in Maryland and presented its arguments supporting the Company's belief that the data contained in its New Drug Application 22-481 support the conclusion that pixantrone is effective for its planned use.

3 Mar 2011

FDA takes action against companies that manufacture unapproved prescription drugs

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

3 Mar 2011

Omeros identifies orphan GPCR compounds associated to pancreatic cancer, cognitive disorders

Omeros Corporation today announced that it has identified compounds that interact selectively with two orphan G protein-coupled receptors linked to pancreatic cancer and cognitive disorders.

3 Mar 2011

New breakthrough in immunological research

Immunological research at the University of Haifa, Israel, has made a new breakthrough, revealing a critical component in the "decision-making" process of white blood cells that play a role in the healing process from bacterial inflammation.

3 Mar 2011

FADD protein discovery can lead to better cancer and autoimmune disease drugs

Reporting in Nature, scientists from Thomas Jefferson University have determined that a single protein called FADD controls multiple cell death pathways, a discovery that could lead to better, more targeted autoimmune disease and cancer drugs.

3 Mar 2011

Study: Men who consume non-steroidals more likely to have erectile dysfunction

Men who take non-steroidal anti-inflammatory drugs three times a day for more than three months are 2.4 times more likely to have erectile dysfunction compared to men who do not take those drugs regularly, according to a Kaiser Permanente study published online in The Journal of Urology.

3 Mar 2011

Portola, Accumetrics sign agreement to develop and supply VerifyNow System

Accumetrics, Inc., a privately-held developer and marketer of the VerifyNow System, the first rapid and easy-to-use point-of-care diagnostic system for measuring platelet reactivity to multiple antiplatelet agents, announced today that the company has signed an agreement with Portola Pharmaceuticals, Inc. to develop and supply the VerifyNow System and VerifyNowTests for use in clinical trials.

3 Mar 2011

Ibuprofen may protect against development of Parkinson's disease

New research suggests that ibuprofen may offer protection against developing Parkinson's disease, according to one of the largest studies to date investigating the possible benefits of the over-the-counter drug on the disease. The study is published in the March 2, 2011, online issue of Neurology®, the medical journal of the American Academy of Neurology.

2 Mar 2011

IAVI, THSTI collaborate to establish HIV Vaccine Design Program in India

The Translational Health Sciences and Technology Institute, an autonomous institute of the Indian government's Department of Biotechnology, and the International AIDS Vaccine Initiative announced today an agreement to jointly establish, operate and fund an HIV Vaccine Design Program in India.

2 Mar 2011

Oxygen Biotherapeutics receives U.S. Army grant for studies of Oxycyte

Oxygen Biotherapeutics, Inc. (NASDAQ and SIX Swiss Exchange: OXBT) today announced it has received a $2,075 million two-year grant from the U.S. Army to study the Company’s proprietary Oxycyte® PFC emulsion as a therapeutic intervention focused on reducing brain damage in victims of traumatic brain injury (TBI).

2 Mar 2011

PreTreat Complete is now available for public to reduce migraine headaches

A new migraine supplement, PreTreat Complete, with active compounds designed to reduce the frequency and intensity of migraine headaches is now available.

2 Mar 2011

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

GTx, Inc. today announced that the company and Ipsen have mutually agreed to terminate their collaboration for the development and commercialization of toremifene.

2 Mar 2011

WARFARIN study to explore impact of genetic testing on individualized dosing

Iverson Genetic Diagnostics, Inc. announced today that the WARFARIN Study was initiated in major hospital systems nationwide to assess the utility of genetic testing to determine a personalized warfarin dose for individual patients to reduce their risk of serious bleeding or clotting events.

2 Mar 2011

Study: Medication adherence alone may not benefit employees with chronic conditions

Medication adherence alone may not be enough to impact the productivity of employees with chronic conditions such as depression, diabetes, hypertension and coronary artery disease.

2 Mar 2011

Inter Press Service explores how Kenya's Anti-Counterfeit Act, possible EU-India free trade agreement could scale back access to affordable medications

Inter Press Service examines how legislation in Kenya targeting counterfeit medications and a possible EU-India Free Trade Agreement could scale back access to affordable and safe generic medications widely used in developing countries.

2 Mar 2011

Trial date set for Teva's generic COPAXONE patent infringement litigation against Momenta

Teva Pharmaceutical Industries Ltd. today announced that the United States District Court for the Southern District of New York has set a trial date of September 7, 2011 in the Company's ongoing patent infringement litigation against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Pharmaceuticals, Inc./Mylan Inc./Natco Pharma Ltd. regarding their purported generic versions of COPAXONE® (glatiramer acetate injection).

2 Mar 2011

Four pharmaceutical companies partner to create new single-source industry

Four successful contract packaging and re-packaging companies in the pharmaceutical industry recently joined forces to create a new, single-source industry leader called Aphena Pharma Solutions.

2 Mar 2011

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).

2 Mar 2011

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Baxter International Inc. announced today the approval of a European repeat mutual recognition procedure (rMRP) by the Austrian Agency for Health and Food Safety for Baxter's PREFLUCEL seasonal influenza vaccine. The 13 participating European Union countries, including Germany, Spain, United Kingdom and Nordic countries, will formally implement the license on a national level to make PREFLUCEL available for the 2011-12 influenza season.

From Baxter International Inc. 2 Mar 2011

Pharmaceutical News

Celerion completes Clean Room, pharmacist certification to comply with USP 797 guidelines

CTI meets officials of FDA's OND to support pixantrone NDA

FDA takes action against companies that manufacture unapproved prescription drugs

Omeros identifies orphan GPCR compounds associated to pancreatic cancer, cognitive disorders

New breakthrough in immunological research

FADD protein discovery can lead to better cancer and autoimmune disease drugs

Study: Men who consume non-steroidals more likely to have erectile dysfunction

Portola, Accumetrics sign agreement to develop and supply VerifyNow System

Ibuprofen may protect against development of Parkinson's disease

IAVI, THSTI collaborate to establish HIV Vaccine Design Program in India

Oxygen Biotherapeutics receives U.S. Army grant for studies of Oxycyte

PreTreat Complete is now available for public to reduce migraine headaches

Ipsen, Gtx terminate collaboration for development and commercialization of toremifene

WARFARIN study to explore impact of genetic testing on individualized dosing

Study: Medication adherence alone may not benefit employees with chronic conditions

Inter Press Service explores how Kenya's Anti-Counterfeit Act, possible EU-India free trade agreement could scale back access to affordable medications

Trial date set for Teva's generic COPAXONE patent infringement litigation against Momenta

Four pharmaceutical companies partner to create new single-source industry

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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