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U.N. Secretary-General urges funding for GAVI during replenishment meeting

U.N. Secretary-General Ban Ki-moon has urged more funding for the GAVI Alliance to help achieve its childhood vaccine targets and the related Millennium Development Goals (MDGs), TopNews reports.

8 Oct 2010

NIAID announces three new contracts to fund research on dengue, anthrax vaccines

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, today announced three new contracts to fund research on vaccines to protect against emerging infectious diseases and biological threats that could be used in a terror attack. Each project focuses on simple and efficient vaccine delivery approaches that could be deployed quickly. The total funding for the three contracts could reach $68 million, depending on the successful completion of defined project milestones.

8 Oct 2010

Novel peptide NX002 demonstrates efficacy in animal model of oral mucositis: Study

NephRx Corporation today announced that a new study has shown that its novel peptide NX002 demonstrated significant efficacy when tested in an animal model of oral mucositis. Mucositis is a debilitating and often dose-limiting side effect of many forms of cancer therapy that affects more than 400,000 patients who receive chemotherapy or radiation treatment in the U.S. each year. Current treatment options are very limited.

8 Oct 2010

Inviragen, PharmaJet awarded NIAID contract to develop needle-free, easy to administer dengue vaccine

Inviragen and PharmaJet announced the award of a five year, $15.5 million dollar contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to advance the development of a needle-free, easy to administer dengue vaccine. The award will fund preclinical studies, regulatory filings, manufacturing and clinical testing of Inviragen's tetravalent dengue vaccine, DENVax delivered with PharmaJet's convenient needle-free injection device.

8 Oct 2010

NIAID awards $6.25M to Profectus to optimize portfolio of genetic adjuvants

Profectus BioSciences, Inc., a technology based vaccine company devoted to the treatment and prevention of chronic viral diseases, today announced that it has received $6.25M in National Institute of Allergy and Infectious Disease (NIAID) grants and contracts.

8 Oct 2010

FDA files complaint for permanent injunction against Brooklyn Juice Company

At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice today filed a complaint for permanent injunction against a Brooklyn juice company to prevent it from processing and distributing juice products.

8 Oct 2010

USPTO issues Patent Notice of Allowance for CIP-TRAMADOL ER drug

Cipher Pharmaceuticals Inc. today announced that the U.S. Patent and Trademark Office has issued a Patent Notice of Allowance for CIP-TRAMADOL ER, the Company's extended-release tramadol product for the treatment of moderate to moderately severe chronic pain in adults.

8 Oct 2010

CQ Healthbeat examines HIV prevention research funding

The global economy has affected HIV/AIDS prevention research, so "scientists and those who fund them are struggling to set priorities among several competing research methods that could slow the spread of the disease, which causes about 2.7 million new infections worldwide a year," CQ HealthBeat reports.

8 Oct 2010

Onyx Pharmaceuticals announces delay in NDA filing for carfilzomib

Onyx Pharmaceuticals, Inc. today announced that it will delay its New Drug Application (NDA) filing for carfilzomib based on a recent meeting with the Chemistry, Manufacturing and Controls (CMC) review division of the U.S. Food and Drug Administration (FDA).

7 Oct 2010

Vical to manufacture pDNA vaccines against HIV

Vical Incorporated today announced that the company has agreed to manufacture plasmid DNA (pDNA) vaccines against HIV under a $2.4 million contract with the IPPOX Foundation, a collaborating institution for the Poxvirus Vaccine Regimen Design (PVRD) led by the Centre Hospitalier Universitaire Vaudois (CHUV) under the auspices of the Collaboration for AIDS Vaccine Discovery (CAVD).

7 Oct 2010

Humana Pharmacy agrees to highest standards of transparency for prescription-drug pricing

Humana Inc. announced today that its Humana Pharmacy Solutions division is one of only five pharmacy-benefit managers (PBMs) in the U.S. to agree to the highest level of transparency for prescription-drug pricing set by the HR Policy Association.

7 Oct 2010

Sucampo submits marketing application for Amitiza drug

Sucampo Pharmaceuticals, Inc. and Abbott today announced that Sucampo Pharma Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc., has submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza (lubiprostone) 24 mcg for the treatment of chronic idiopathic constipation (CIC).

7 Oct 2010

Semi-synthetic opioid may improve withdrawal symptoms in infants

Thousands of infants each year have exposure to opioids before they are born. Over half of these infants are born with withdrawal symptoms severe enough to require opioid replacement treatment in the nursery. Such treatment is associated with long hospital stays which interferes with maternal/infant bonding. Now, a team of researchers at Thomas Jefferson University has tested a semi-synthetic opioid they say has the potential to improve the treatment of these newborns, which could save hundreds of millions in healthcare costs annually if future tests continue to show benefit.

7 Oct 2010

Synthetic Genomics, JCVI announce formation of new company to develop next generation vaccines

The company Synthetic Genomics Inc. (SGI) and the not-for-profit research organization, the J. Craig Venter Institute (JCVI) today announced the formation of a new company, Synthetic Genomics Vaccines Inc. (SGVI).

7 Oct 2010

Cortex secures patent rights for combined use of AMPAKINE and mGluR5 compounds for Fragile X syndrome treatment

Cortex Pharmaceuticals, Inc. announced that the rights to a published patent application entitled, "Pharmacological Modulation of Positive AMPA Receptor Modulator Effects on Neurotrophin Expression", has been licensed exclusively to Cortex from the University of California.

7 Oct 2010

ANDA approved for Losartan Potassium Tablets USP, Losartan Potassium and Hydrochlorothiazide Tablets

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application for Losartan Potassium Tablets USP, 25mg, 50mg and 100mg as well as Losartan Potassium and Hydrochlorothiazide Tablets, 50mg/12.5mg and 100mg/25mg by the U.S. Food and Drug Administration. Both products are available for immediate shipment to wholesalers and pharmacies nationwide.

7 Oct 2010

Quintiles, SNUH announce clinical research partnership

Quintiles, the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, today celebrated its 10th year anniversary in South Korea by announcing a strategic alliance with the Seoul National University Hospital (SNUH) as part of its unique Prime Site program. SNUH is Quintiles' second Prime Site in Asia, adding to six other existing sites located in the United States, Europe and Africa.

7 Oct 2010

Roche receives development and commercialization rights for danoprevir drug

InterMune, Inc. today announced that it has sold worldwide development and commercialization rights to danoprevir (also known as RG7227 or ITMN-191) to Hoffman-La Roche Inc. and F. Hoffman-La Roche Ltd. for $175 million in cash.

7 Oct 2010

New report focuses on management of renal anemia amongst dialysis, later stage CKD patients

BioTrends Research Group, Inc. recently published its TreatmentTrends: Renal Anemia in China report. This report is based on survey results from 150 nephrologists in clinical practice in China and qualitative interviews conducted with ten thought leaders in nephrology. The report examines the demographics of nephrology practice in China and focuses specifically on the management of renal anemia amongst dialysis and later stage chronic kidney disease patients.

7 Oct 2010

Pharmaxis receives FDA approval to market ARIDOL Test Kit

Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for chronic respiratory and immune disorders, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades.

7 Oct 2010

Pharmaceutical News

U.N. Secretary-General urges funding for GAVI during replenishment meeting

NIAID announces three new contracts to fund research on dengue, anthrax vaccines

Novel peptide NX002 demonstrates efficacy in animal model of oral mucositis: Study

Inviragen, PharmaJet awarded NIAID contract to develop needle-free, easy to administer dengue vaccine

NIAID awards $6.25M to Profectus to optimize portfolio of genetic adjuvants

FDA files complaint for permanent injunction against Brooklyn Juice Company

USPTO issues Patent Notice of Allowance for CIP-TRAMADOL ER drug

CQ Healthbeat examines HIV prevention research funding

Onyx Pharmaceuticals announces delay in NDA filing for carfilzomib

Vical to manufacture pDNA vaccines against HIV

Humana Pharmacy agrees to highest standards of transparency for prescription-drug pricing

Sucampo submits marketing application for Amitiza drug

Semi-synthetic opioid may improve withdrawal symptoms in infants

Synthetic Genomics, JCVI announce formation of new company to develop next generation vaccines

Cortex secures patent rights for combined use of AMPAKINE and mGluR5 compounds for Fragile X syndrome treatment

ANDA approved for Losartan Potassium Tablets USP, Losartan Potassium and Hydrochlorothiazide Tablets

Quintiles, SNUH announce clinical research partnership

Roche receives development and commercialization rights for danoprevir drug

New report focuses on management of renal anemia amongst dialysis, later stage CKD patients

Pharmaxis receives FDA approval to market ARIDOL Test Kit

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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