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Human growth hormone can treat cystic fibrosis symptoms

Human growth hormone can be used successfully to treat some symptoms of cystic fibrosis, but its impact on the disease itself remains unknown, according to a new report funded by HHS' Agency for Healthcare Research and Quality (AHRQ).

5 Oct 2010

FDA approves Food Contact Notification for CDG Solution 3000

The FDA notified CDG Environmental, LLC on September 29th of its approval of Food Contact Notification FCN 001011 for CDG Solution 3000 effective October 28, 2010.

5 Oct 2010

Aeras Global receives FDA grant to develop biomarkers for TB vaccine

The Aeras Global TB Vaccine Foundation is pleased to announce receipt of a grant from the United States Food and Drug Administration (FDA) to develop new biological and immunological biomarkers for TB vaccine development. The FDA grant, which supports the coordination of a multi-investigator project with researchers from the United States, the United Kingdom and South Africa, will provide $362,102 in the first year of funding.

5 Oct 2010

FDA awards $2.9 million to support tuberculosis research projects

The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).

5 Oct 2010

Estech adds COBRA Revolution Bipolar Clamp to ablation product line

Estech, a leading provider of minimally invasive cardiac surgery devices, today announced the launch of its COBRA Revolution™ Bipolar Clamp for use in surgical ablation procedures. The new instrument enables deep transmural lesion formation after a single application and is the only clamp to feature reversible jaws, which uniquely allows surgeons to follow anatomic contours, for unprecedented ease of use and efficiency.

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Egg allergies may be prevented by early introduction: Study

Contrary to popular belief that eggs should not be introduced into the diet before the first birthday of the baby, a new study shows that parents who do not want their newborn babies to develop an egg allergy ought to feed them eggs in the first six months of life.

4 Oct 2010

FDA announces dates for public hearing on Biologics Price Competition and Innovation Act of 2009

The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2-3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, room 1503, in Silver Spring, Md.

4 Oct 2010

GlobalNet Services awarded $14M contract to support FDA Unified Registration and Listing System

GlobalNet Services, Inc., a premier information technology provider for businesses and the Federal government, today announced that it had been awarded a $14 million contract to support the U.S. Food and Drug Administration's (FDA) Unified Registration and Listing System (FURLS). This five-year contract, which includes one base year and four option years, supports federal initiatives that require all facilities, which manufacture, process or hold FDA-regulated products to be registered with the Agency.

4 Oct 2010

FDA clears Orthovita's VITOMATRIX Bone Graft Substitute for dental procedures

Orthovita, Inc., an orthobiologics and biosurgery company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration to market VITOMATRIX Bone Graft Substitute as a bone grafting material in certain dental procedures.

4 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

FDA approves NovaBone Putty MIS Delivery System for orthopedic surgery

NovaBone Products, a medical device company, today announces the U.S. Food and Drug Administration's (FDA) approval of the NovaBone Putty® MIS Delivery System designed for use in minimally invasive orthopedic procedures.

4 Oct 2010

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Mylan subsidiary receives FDA approval for Fludarabine Phosphate Injection ANDA

Mylan Inc. today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).

4 Oct 2010

JASH journal added to MEDLINE collection

Elsevier announces that the Journal of the American Society of Hypertension (JASH) has been selected for inclusion in MEDLINE. MEDLINE is the premier bibliographic database of the U.S. National Library of Medicine (NLM), containing over 15 million journal article citations, with a concentration on biomedicine.

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Saturated fat intake has limited impact on CVD risk: Research

For the past three decades, saturated fat has been considered a major culprit of cardiovascular disease (CVD) and as a result dietary advice persists in recommending reduced consumption of this macronutrient. However, new evidence shows that saturated fat intake has only a very limited impact on CVD risk causing many to rethink the "saturated fat is bad" paradigm.

4 Oct 2010

New SymPath kit measures DBH activity of Sympathetic Nervous System

Biotech Corporation in acquiring licenses to commercialize 12 Neuro-biomarkers has first focused on SymPath(R) and is now ready to give you the opportunity to shed some light about this Neuro-biomarker of the Sympathetic Nervous System (SNS). Here is a peak into the research behind the Neuro-blood testing that will be available to all patients through their health system.

4 Oct 2010