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APCER PHARMA to demonstrate pharmacovigilance/drug safety and regulatory services at GPhA meeting

APCER PHARMA executives will discuss and demonstrate their expertise in providing generic drug manufacturers with the best in class pharmacovigilance/drug safety, regulatory and risk management services at the GPhA Annual Meeting, February 16-18, at the Ritz-Carlton in Naples, Florida. APCER will be in Booth #27.

17 Feb 2010

Adding daclizumab to standard treatment reduces enlarged brain lesions in patients with relapsing MS

An international team of researchers has found that adding a humanized monoclonal antibody called daclizumab to standard treatment reduces the number of new or enlarged brain lesions in patients with relapsing multiple sclerosis. This new study was published online Feb. 16, 2010, and in the March edition of the Lancet Neurology.

17 Feb 2010

Combination of daclizumab and interferon beta significantly reduces MS lesion formation

Biogen Idec and Facet Biotech Corporation today announced the publication of Phase 2 data showing that the addition of daclizumab to interferon beta (IFNβ) led to a significant reduction in the number of new or enlarged multiple sclerosis (MS) lesions when compared to IFNβ alone in patients with active relapsing forms of MS.

17 Feb 2010

NanoViricides signs research and development agreement with Dr. Eva Harris’s laboratory at UC Berkeley

NanoViricides, Inc. (the "Company"), reports that it has signed a research and development agreement with Dr. Eva Harris’s laboratory at the University of California, Berkeley (UC Berkeley).

17 Feb 2010

Bedford Laboratories launches Indomethacin for Injection

Bedford Laboratories™, a division of Ben Venue Laboratories, Inc., a provider of select specialty injectables, is pleased to announce the addition of Indomethacin for Injection to its existing product line. This product is AP rated and is equivalent to Indocin® by Lundbeck, Inc. Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.

17 Feb 2010

CMAJ study: Increased dosage of Tamiflu required in treating H1N1 influenza patients

An increased dosage of Tamiflu (oseltamivir) for patients with critical illness is unlikely to be required in the treatment of pandemic (H1N1) influenza, contrary to current international guidelines, found a new study http://www.cmaj.ca/cgi/doi/10.1503/cmaj.092127 in CMAJ (Canadian Medical Association Journal) www.cmaj.ca.

17 Feb 2010

Amgen and Centocor Ortho Biotech Products: FDA approves REMS for Aranesp, EPOGEN and PROCRIT ESAs

Amgen Inc. and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa) and PROCRIT® (Epoetin alfa).

17 Feb 2010

Quark Pharmaceuticals' QPI-1002 receives orphan drug designation from FDA

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced today that the US FDA has granted orphan drug designation for QPI-1002 (also referred to as "I5NP"), a synthetic siRNA targeting p53 mRNA for the prophylaxis of delayed graft function (DGF) in kidney transplant patients.

17 Feb 2010

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for drug dependence, smoking cessation and obesity, announced today that the company has retained Exponential Pharma Ventures LLC to assist in establishing a clinical development partnership for its cocaine dependence program with a fully integrated pharmaceutical company.

17 Feb 2010

TopoTarget pays Celldex Therapeutics $3M sublicense income over Belinostat co-development agreement

Celldex Therapeutics, Inc. today announced that it has received a sublicense income payment of $3 million from TopoTarget A/S as a result of the recent co-development and commercialization agreement between TopoTarget and Spectrum Pharmaceuticals, Inc. for Belinostat, a novel histone deacetylase (HDAC) inhibitor for the treatment of cancer.

17 Feb 2010

FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone HCl) extended-release tablets New Drug Application (NDA) from Monday, February 22, 2010 to Monday, March 1, 2010 due to federal government closings.

16 Feb 2010

EntreMed's ENMD-2076 for AML receives FDA's orphan drug designation

EntreMed, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company's lead oncology drug candidate, ENMD-2076, for the treatment of acute myeloid leukemia (AML).

16 Feb 2010

BUSACC hosts breakfast panel over reconstruction opportunities in Iraq, covering healthcare and pharma

The reconstruction of Iraq is under way and opportunities for Texas businesses abound. The Bilateral U.S. – Arab Chamber of Commerce (BUSACC) is hosting a business breakfast and panel discussion featuring Iraq’s Ambassador to the United States, the Senior Commercial Counsel and a high level Ministry of Energy official and delegation, along with American risk and security mitigation experts.

16 Feb 2010

Meda publishes 2009 year-end report

“The Meda Group expects to achieve sales of about SEK 13,000 million and an EBITDA of about SEK 4,200 million for full-year 2009.”

16 Feb 2010

VPCI pioneers on-demand GMP consultation services for Pharmaceutical manufacturers

Pharmaceutical manufacturers around the world now have access to high-level, FDA support services at the touch of a button. VPCI (Vectech Pharmaceutical Consultants International) has pioneered a "Virtual GMP Consulting" service. Through the use of high definition video conferencing equipment and collaboration software, Pharmaceutical manufacturers now have access to GMP consultation services on-demand, and at a fraction of the cost.

16 Feb 2010

Overall benefits of HPV vaccination or frequent screening are low for women over 41

The overall potential benefits of human papillomavirus (HPV) vaccinations or frequent HPV screenings for women over the age of 41 are low, concludes a new study published online February 15 in the Journal of the National Cancer Institute. The study found that the rate of new infections preventable by vaccination declines with age. Furthermore, new infections among women at any age typically do not progress to cervical intraepithelial neoplasia grade 2 (CIN 2) or CIN 3, the precursors for cervical cancer.

16 Feb 2010

When blood sugar levels rise in healthy people, insulin signals cells to increase production: Study

In type 2 diabetes, which is occurring at alarming rates, the hormone insulin does not work effectively to lower blood sugars and patients also do not make enough insulin. These two processes have been widely considered as separate.

16 Feb 2010

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

AstraZeneca and Rigel Pharmaceuticals today announced an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications.

16 Feb 2010

Three Dutch life-science sectors announce joint investment to research on personalized medicine

The Netherlands' three Top Institutes for life-science research (the BioMedical Materials program, the Center for Translational Molecular Medicine and Top Institute Pharma) today announced a joint investment of MEUR 28 on innovative research targeted at bringing personalized medicine closer to reality.

16 Feb 2010

Use of non-steroidal anti-inflammatory drugs not associated with risk of squamous cell skin cancer

Contrary to previous hypotheses, the use of non-steroidal anti-inflammatory drugs does not appear associated with risk of squamous cell skin cancer, according to a report posted online today that will appear in the April print issue of Archives of Dermatology, one of the JAMA/Archives journals.

16 Feb 2010

Pharmaceutical News

APCER PHARMA to demonstrate pharmacovigilance/drug safety and regulatory services at GPhA meeting

Adding daclizumab to standard treatment reduces enlarged brain lesions in patients with relapsing MS

Combination of daclizumab and interferon beta significantly reduces MS lesion formation

NanoViricides signs research and development agreement with Dr. Eva Harris’s laboratory at UC Berkeley

Bedford Laboratories launches Indomethacin for Injection

CMAJ study: Increased dosage of Tamiflu required in treating H1N1 influenza patients

Amgen and Centocor Ortho Biotech Products: FDA approves REMS for Aranesp, EPOGEN and PROCRIT ESAs

Quark Pharmaceuticals' QPI-1002 receives orphan drug designation from FDA

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

TopoTarget pays Celldex Therapeutics $3M sublicense income over Belinostat co-development agreement

FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

EntreMed's ENMD-2076 for AML receives FDA's orphan drug designation

BUSACC hosts breakfast panel over reconstruction opportunities in Iraq, covering healthcare and pharma

Meda publishes 2009 year-end report

VPCI pioneers on-demand GMP consultation services for Pharmaceutical manufacturers

Overall benefits of HPV vaccination or frequent screening are low for women over 41

When blood sugar levels rise in healthy people, insulin signals cells to increase production: Study

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

Three Dutch life-science sectors announce joint investment to research on personalized medicine

Use of non-steroidal anti-inflammatory drugs not associated with risk of squamous cell skin cancer

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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