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NerPharMa facility receives FDA approval to manufacture CTI's drug pixantrone

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product.

8 Mar 2010

U-M scientists identify new reservoir for hidden HIV-infected cells that can serve as factory for new infections

University of Michigan scientists have identified a new reservoir for hidden HIV-infected cells that can serve as a factory for new infections. The findings, which appear online March 7 in Nature Medicine, indicate a new target for curing the disease so those infected with the virus may someday no longer rely on AIDS drugs for a lifetime.

8 Mar 2010

Scientists show Ritalin boosts cognitive abilities by enhancing brain plasticity

Doctors treat millions of children with Ritalin every year to improve their ability to focus on tasks, but scientists now report that Ritalin also directly enhances the speed of learning.

8 Mar 2010

Leadership challenges and best practices in dealing with FDA’s REMS

Three pharmaceutical executives with extensive experience in dealing with the FDA’s Risk Evaluation and Mitigation Strategy (REMS) will share their thoughts and practices at an open industry webinar at 12 noon EST on Wednesday, March 10, sponsored by ParagonRx.

6 Mar 2010

Nordic Naturals' products surpass all PCB standards set by California's Proposition 65

Nordic Naturals announced today that the company's products surpass all PCB standards set by California's Proposition 65, the GOED voluntary monograph, and all international standards. Nordic Naturals products were not listed in the lawsuit filed in California alleging that eight fish oil companies did not properly label products regarding PCB levels under the state's Proposition 65.

6 Mar 2010

Abt Associates receives two new contracts to evaluate effectiveness of H1N1 vaccine

The Centers for Disease Control and Prevention has awarded Abt Associates two new contracts to evaluate the effectiveness of the H1N1 vaccine among health care workers and children under the age of 18.

6 Mar 2010

Peptimmune granted US patent for PI-2301 peptide copolymer in treatment of multiple sclerosis

Peptimmune, Inc. a privately held biotechnology company, announced today the grant of US Patent Number 7,655,221 (the '221 patent) which protects the target product profile for its PI-2301 peptide copolymer for the treatment of multiple sclerosis, and other autoimmune diseases.

6 Mar 2010

Lancet World Report examines GAVI's funding gap

Lancet World Report examines the challenges ahead for the GAVI Alliance, which after a decade of "steadily increasing financing" is now "facing a funding shortfall for the next decade that could hamper the roll-out of new vaccines." GAVI leaders attribute the funding challenges to the global economic crisis, which has kept government aid budgets from increasing, according to the Lancet.

6 Mar 2010

Soluble Systems, SWAI launch TheraSkin to jumpstart healing in chronic and acute wounds

Soluble Systems, LLC and the Skin and Wound Allograft Institute, a wholly owned subsidiary of LifeNet Health, have signed a noteworthy agreement to launch TheraSkin™, a biologically active human skin allograft designed to jumpstart healing in chronic and acute wounds.

6 Mar 2010

Hypertension: Regular nifedipine administration may lead to development of GERD

Nifedipine, a calcium-channel blocker, was shown to decrease lower esophageal sphincter pressure and increase esophageal acid exposure time, while atenolol, a b1 blocker, was shown to inhibit relaxation of the smooth muscle of the esophagus. However, the influence of these anti-hypertensive drugs on the segment of esophageal body contraction using high-resolution manometry was not fully investigated.

5 Mar 2010

New anti-tumour vaccine for mesothelioma shows promising results

A vaccine against mesothelioma, a cancer associated with exposure to asbestos, has shown early promise in its first clinical trial.

5 Mar 2010

Varian launches next generation dissolution apparatus

Varian, Inc. announced today the availability of its next generation dissolution apparatus designed for testing tablets, capsules and other dosage forms. The 708-DS supports a broad set of applications ranging from manual dissolution testing to automated, high-throughput analysis. It provides extensive flexibility to match the needs of individual laboratories, whether in research or testing. Integration with either the new Varian UV or LC Dissolution Systems will save time and reduce the potential for sample handling errors.

5 Mar 2010

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. The proposed trade name for pirfenidone is Esbriet®.

5 Mar 2010

Bristol-Myers Squibb to review key accomplishments at meeting with investment community

During a meeting with the investment community today, Bristol-Myers Squibb Company will provide a comprehensive business overview, highlight positive pipeline developments and provide 2013 minimum non-GAAP earnings per share guidance.

5 Mar 2010

Research reveals maple syrup and maple water contain abscisic acid

Thanks to modern science, the closely guarded secrets of one of our nation's most distinctive emblems, maple syrup, are now being revealed. It has recently been reported that maple syrup contains polyphenols and shows ORAC values which compare to commonly eaten fruits and vegetables such as broccoli.

5 Mar 2010

CVS calls for Senate and House Health Committees to hold public hearings on vaccine safety

The Coalition for Vaccine Safety (CVS) comprises organizations representing over 75,000 families dedicated to vaccine safety. It formed in February 2010 to address urgent concerns about insufficient vaccine safety science. On February 24, it called on Senate and House Health Committees to hold public hearings on vaccine safety.

5 Mar 2010

Vioxx: Australian Court dismisses all claims against Merck

Today, the Federal Court in Australia published its judgment in the Peterson case. The Court found against MSD Australia on two claims under Australian statutory provisions. The Court dismissed all claims against Merck & Co., Inc. specifically finding that Merck was not negligent in its development, scientific study and sale of Vioxx. Merck and MSD Australia disagree with the limited portions of the Court’s findings that were against MSD Australia and intend to appeal them.

5 Mar 2010

Forteo to remain Decision Resources' proprietary clinical gold standard for treatment of osteoporosis

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a drug's effect on reduction of new hip fractures is the attribute that most influences U.S. and European surveyed primary care physicians' (PCPs') prescribing decisions in osteoporosis.

5 Mar 2010

Study finds Pfizer's pneumonia, meningitis vaccine protects against recurrent pneumonia in HIV patients

Pfizer's Prevnar 7 vaccine, which protects against pneumonia and meningitis, has been shown to reduce the risk of recurrent pneumococcal infection in patients living with HIV in Malawi, according to a study published Thursday in the New England Journal of Medicine, Reuters reports.

5 Mar 2010

KAPIDEX to be marketed as DEXILANT in the U.S.

Takeda Pharmaceuticals North America, Inc. announced today that KAPIDEX™ (dexlansoprazole) will be marketed in the United States under the new product trade name DEXILANT™ (dexlansoprazole). The product is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.

5 Mar 2010

Pharmaceutical News

NerPharMa facility receives FDA approval to manufacture CTI's drug pixantrone

U-M scientists identify new reservoir for hidden HIV-infected cells that can serve as factory for new infections

Scientists show Ritalin boosts cognitive abilities by enhancing brain plasticity

Leadership challenges and best practices in dealing with FDA’s REMS

Nordic Naturals' products surpass all PCB standards set by California's Proposition 65

Abt Associates receives two new contracts to evaluate effectiveness of H1N1 vaccine

Peptimmune granted US patent for PI-2301 peptide copolymer in treatment of multiple sclerosis

Lancet World Report examines GAVI's funding gap

Soluble Systems, SWAI launch TheraSkin to jumpstart healing in chronic and acute wounds

Hypertension: Regular nifedipine administration may lead to development of GERD

New anti-tumour vaccine for mesothelioma shows promising results

Varian launches next generation dissolution apparatus

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

Bristol-Myers Squibb to review key accomplishments at meeting with investment community

Research reveals maple syrup and maple water contain abscisic acid

CVS calls for Senate and House Health Committees to hold public hearings on vaccine safety

Vioxx: Australian Court dismisses all claims against Merck

Forteo to remain Decision Resources' proprietary clinical gold standard for treatment of osteoporosis

Study finds Pfizer's pneumonia, meningitis vaccine protects against recurrent pneumonia in HIV patients

KAPIDEX to be marketed as DEXILANT in the U.S.

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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