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FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine

Pfizer Inc. announced today that the United States Food and Drug Administration has granted approval for Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company’s 13-valent pneumococcal conjugate vaccine.

25 Feb 2010

SBi's Mini-Rail System and Cannulated Screw System receive FDA pre-market clearance

Small Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, announced that it has received 510(k) pre-market clearance notifications from the U.S. Food and Drug Administration (FDA) for Mini-Rail Fixation System (‘Mini-Rail System’) and large Cannulated Screw System for use in lower limb reconstruction and repair procedures.

25 Feb 2010

Unique technology identifies drug candidates, speeds up drug development

The search for new therapeutic agents is time-consuming and expensive. Pharmaceutical companies may have to screen thousands of compounds for the ability to bind a target molecule before they hit upon a promising drug candidate.

From NanoTemper Technologies 24 Feb 2010

FDA approves Wyeth Pharmaceuticals' Prevnar 13 pneumococcal disease vaccine

The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

24 Feb 2010

FDA accepts Arena Pharmaceuticals' lorcaserin NDA

Arena Pharmaceuticals, Inc. announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, has been accepted for filing by the US Food and Drug Administration (FDA). Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA) date in the next few weeks. The PDUFA date is the target date for the FDA to complete its review of an NDA.

24 Feb 2010

Edesia receives $2M grant from USAID to produce more than 300 metric tons of Nutributter in 2010

Edesia LLC, a non-profit producer of life-saving Ready-to-Use Foods (RUFs), is the recipient of a $2 million multi-year grant from the U.S. Agency for International Development.

24 Feb 2010

Nutrition 21: Health Canada approves chromium picolinate for sale as a natural health product

Nutrition 21, Inc., the developer and marketer of nutritional ingredients for the dietary supplement, functional food and beverage markets announced today that chromium picolinate has been officially approved for sale in Canada as a natural health product by Health Canada, the Canadian federal agency devoted to maintaining and improving the health of the nation's citizens. As a result of this approval, Nutrition 21 can now sell its Chromax® brand of chromium picolinate to Canadian manufacturers, marketers, and importers of natural health products.

24 Feb 2010

Osiris Therapeutics' net income for fourth-quarter 2009 increases to $15.7M

Osiris Therapeutics, Inc., the leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, cardiovascular and orthopedic areas, announced today its results for the fourth quarter and year ended December 31, 2009.

24 Feb 2010

FDA's warning over LABA medications for asthma: AANMA offers guidance

Today Allergy & Asthma Network Mothers of Asthmatics (AANMA) offered guidance to help patients understand recent Food and Drug Administration (FDA) warnings about Advair ® (fluticasone and salmeterol), Foradil ® (formoterol), Severent ® (salmeterol) and Symbicort ® (budesonide and formoterol), daily inhaled medications containing a long-acting beta agonist (LABA, a 12-hour bronchodilator).

24 Feb 2010

Over-produced PKC-iota oncogene linked to poor pancreatic cancer patient survival

Researchers at the Mayo Clinic campus in Florida have found that PKC-iota (PKC), an oncogene important in colon and lung cancers, is over-produced in pancreatic cancer and is linked to poor patient survival. They also found that genetically inhibiting PKC in laboratory animals led to a significant decrease in pancreatic tumor growth and spread.

24 Feb 2010

Early implantation of cochlear devices in deaf children leads to better overall quality of life

Profoundly deaf children with cochlear implants to help them to hear rate their quality of life equal to their normal-hearing peers, according to new research from UT Southwestern Medical Center auditory specialists.

24 Feb 2010

Nominations accepted for 2010 George Washington Carver Award

The third annual George Washington Carver Award will recognize significant contributions by an individual to the field of industrial biotechnology, including applications in biological engineering, environmental science, biorefining and biobased products. The Biotechnology Industry Organization today announced that it is accepting nominations for the 2010 George Washington Carver Award, which will be presented at the 2010 World Congress on Industrial Biotechnology and Bioprocessing, June 27-30, 2009 in Washington, D.C.

24 Feb 2010

Reporting problems associated with FDA-regulated products help protect health and safety of all Americans

Reports submitted to the Food and Drug Administration are an important part of the agency's strategy for identifying risks with products after they've reached the market. These reports help FDA protect the health and safety of all Americans—and can ultimately save lives.

24 Feb 2010

CCEI gives opportunity to child care professionals to support childhood obesity campaign

ChildCare Education Institute gives child care professionals the opportunity to aid the campaign against childhood obesity. Child care staff can enroll in HLTH100: Early Childhood Obesity, at no cost, and learn strategies for combating childhood obesity.

24 Feb 2010

FDA recommends H1N1 for inclusion in next year's flu vaccine

The U.S. Food and Drug Administration (FDA) on Monday recommended that the H1N1 (swine flu) strain be added to next year's seasonal flu vaccine, "putting an end to separate shots deployed against the pandemic," Bloomberg reports. The FDA committee voted unanimously to make the H1N1 strain one of the three strains included in the shot, according to the news service. "The panel's recommendations are routinely adopted and used to guide vaccine manufacturers," Bloomberg writes (Randall, 2/22).

24 Feb 2010

FDA: Invirase-Norvir combination therapy for HIV may adversely affect the heart

The U.S. Food and Drug Administration today announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.

24 Feb 2010

Watson Pharmaceuticals' fourth-quarter net revenue rises 22%

Watson Pharmaceuticals, Inc. today reported net revenue for the fourth quarter ended December 31, 2009 climbed 22 percent to $785.7 million, compared to $645.2 million in the fourth quarter 2008.

24 Feb 2010

Shop at the perimeter of grocery stores to fight weight gain

Shopping the perimeter of your local grocery store and avoiding the aisles will give you a head start on fighting the battle of the bulge.

24 Feb 2010

FDA grants EUA for Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay in CLIA high complexity laboratories

Longhorn Vaccines & Diagnostics today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ in CLIA high complexity laboratories. . The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ is a ready-use assay that requires no mixing prior to use and has been authorized for use on the ABI 7500.

24 Feb 2010

Pathogen study could provide new insights on gene regulation

About 50 percent of the world's population carry Helicobacter pylori (H. pylori) in their gastrointestinal tract - 30 percent of the German population are infected. Besides cancer, these bacteria are linked to other chronic diseases such as cardiovascular disease.

24 Feb 2010

Food News and Research

FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine

SBi's Mini-Rail System and Cannulated Screw System receive FDA pre-market clearance

Unique technology identifies drug candidates, speeds up drug development

FDA approves Wyeth Pharmaceuticals' Prevnar 13 pneumococcal disease vaccine

FDA accepts Arena Pharmaceuticals' lorcaserin NDA

Edesia receives $2M grant from USAID to produce more than 300 metric tons of Nutributter in 2010

Nutrition 21: Health Canada approves chromium picolinate for sale as a natural health product

Osiris Therapeutics' net income for fourth-quarter 2009 increases to $15.7M

FDA's warning over LABA medications for asthma: AANMA offers guidance

Over-produced PKC-iota oncogene linked to poor pancreatic cancer patient survival

Early implantation of cochlear devices in deaf children leads to better overall quality of life

Nominations accepted for 2010 George Washington Carver Award

Reporting problems associated with FDA-regulated products help protect health and safety of all Americans

CCEI gives opportunity to child care professionals to support childhood obesity campaign

FDA recommends H1N1 for inclusion in next year's flu vaccine

FDA: Invirase-Norvir combination therapy for HIV may adversely affect the heart

Watson Pharmaceuticals' fourth-quarter net revenue rises 22%

Shop at the perimeter of grocery stores to fight weight gain

FDA grants EUA for Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay in CLIA high complexity laboratories

Pathogen study could provide new insights on gene regulation

Enhancing confidence in chemical ionization spectrometry data eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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