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Perrigo receives final FDA approval for diclofenac sodium topical solution 1.5% w/w

Perrigo Company plc today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for diclofenac sodium topical solution 1.5% w/w. Shipments to our pharmacy customers have commenced.

2 Dec 2014

Benvenue Medical's Luna 360 System receives FDA clearance for spinal fusion treatment of DDD

Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced that the company's Luna 360 Interbody Fusion System has received 510(k) clearance from the U.S. Food and Drug Administration for spinal fusion treatment of symptomatic degenerative disc disease (DDD).

2 Dec 2014

BioPharmX submits request for pre-IND meeting to FDA for topical antibiotic acne compound

BioPharmX Corporation, a biotechnology company focused on the development of novel drug delivery products to address unmet needs in large, well-defined and underserved markets, today announced that it has submitted a request for a pre-IND (Investigational New Drug) meeting to the U.S. Food and Drug Administration for the company's topical antibiotic acne compound currently under development.

2 Dec 2014

Oncolytics Biotech submits Orphan Drug Designation for pancreatic, ovarian cancers

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) today announced that it has submitted applications for Orphan Drug Designation to the U.S. Food and Drug Administration ("FDA") for REOLYSIN® for the treatment of pancreatic and ovarian cancers.

2 Dec 2014

New IDF guidelines can serve as valuable resource for studying heat resistance of bacteria

Using a common methodology to measure heat resistance of bacteria is crucial, so that the results of different studies can be compared.

2 Dec 2014

Average child only eats 60% of food when parents are not around

Whereas most adults are members of the Clean Plate Club, they eat an average of about 90% of the food they serve themselves, this is not true for children.

2 Dec 2014

New FDA data shows disparities still exist in medical research

The U.S. Food and Drug Administration (FDA) released data today on a dedicated website from six studies reflecting a two-month period in response to a requirement under the "FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data" to make transparent the percentage of female and minority participation in clinical trials for medications intended for all populations.

2 Dec 2014

UT Austin researchers identify network of genes that drives alcohol dependence

Researchers at The University of Texas at Austin have identified a network of genes that appear to work together in determining alcohol dependence. The findings, which could lead to future treatments and therapies for alcoholics and possibly help doctors screen for alcoholism, are being published this week in the journal Molecular Psychiatry.

2 Dec 2014

Alim Louis Benabid, Mahlon DeLong jointly win 2014 Lasker-DeBakey Clinical Medical Research Award

French neurosurgeon Alim Louis Benabid and American neurologist Mahlon DeLong were recently named winners of the 2014 Lasker-DeBakey Clinical Medical Research Award for their roles in developing deep brain stimulation (DBS) for the treatment of Parkinson disease.

2 Dec 2014

Study shows how specific trauma changes into a state of generalized fear

"I can't get the memories out of my mind!... I am right back in Vietnam, in the middle of the monsoon season at my guard post. My hands are freezing, yet sweat pours from my entire body...I smell a damp sulfur smell. Suddenly I see what's left of my buddy Troy, his head on a bamboo platter, sent back to our camp by the Viet Cong."

2 Dec 2014

Researchers warn that Vitamin A deficiency can cause eye problems

Obese patients who have undergone bariatric surgery to shed weight should take the supplements prescribed to them to protect their eyes. Taking in too little Vitamin A, in particular, could in some cases actually cause night blindness, dry eyes, corneal ulcers, and in extreme cases total blindness. This advice comes from Rui Azevedo Guerreiro and Rui Ribeiro of the Centro Hospitalar de Lisboa Central in Portugal, who reviewed what little research there currently is on the occurrence of eye conditions following bariatric surgery.

2 Dec 2014

Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

Nektar Therapeutics reported that partner Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the United States Food and Drug Administration for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

From Baxter International Inc. 1 Dec 2014

Mylan enters into agreement with Gilead Sciences to manufacture, distribute Tenofovir Alafenamide

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences, Inc. under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs.

1 Dec 2014

Clementia's palovarotene receives FDA Fast Track designation for FOP treatment

Clementia Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has granted Fast Track designation to palovarotene, which is being developed for the treatment of fibrodysplasia ossificans progressiva (FOP).

1 Dec 2014

Cepheid gets FDA clearance to market Xpert Norovirus

Cepheid today announced it has received clearance from the U.S. Food & Drug Administration to market Xpert Norovirus, a qualitative in vitro diagnostic test for expeditious identification and differentiation of Noroviruses genogroup I (GI) and genogroup II (GII).

1 Dec 2014

CHFA reveals top five healthy holiday gift ideas

Finding that perfect gift for health-conscious friends and family can be hard, but this holiday season, you can put those fears to rest.

1 Dec 2014

IMRIS successfully completes human factors study for SYMBIS Surgical System

IMRIS Inc. today announced that the Company has successfully completed the human factors study for the SYMBIS Surgical System – the comprehensive validation used to support the product's 510(k) submission to the U.S. Food and Drug Administration on November 26.

1 Dec 2014

Endomagnetics gets FDA's IDE approval to begin clinical trial of SentiMag and Sienna+ system

Cancer healthcare company Endomagnetics announced today that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration to initiate a pivotal clinical trial to evaluate the safety and effectiveness of the SentiMag and Sienna+ magnetic sentinel lymph node biopsy system in the management of breast cancer.

1 Dec 2014

New book explores convergence as key to stable global agricultural platform

A scientific text, Convergence of Food Security, Energy Security and Sustainable Agriculture, is now available through Springer Science+Business Media.

1 Dec 2014

EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

Pharmacyclics, Inc.today announced the acceptance of a Type II variation application for IMBRUVICA (ibrutinib) by the European Medicines Agency.

1 Dec 2014

Food News and Research

Perrigo receives final FDA approval for diclofenac sodium topical solution 1.5% w/w

Benvenue Medical's Luna 360 System receives FDA clearance for spinal fusion treatment of DDD

BioPharmX submits request for pre-IND meeting to FDA for topical antibiotic acne compound

Oncolytics Biotech submits Orphan Drug Designation for pancreatic, ovarian cancers

New IDF guidelines can serve as valuable resource for studying heat resistance of bacteria

Average child only eats 60% of food when parents are not around

New FDA data shows disparities still exist in medical research

UT Austin researchers identify network of genes that drives alcohol dependence

Alim Louis Benabid, Mahlon DeLong jointly win 2014 Lasker-DeBakey Clinical Medical Research Award

Study shows how specific trauma changes into a state of generalized fear

Researchers warn that Vitamin A deficiency can cause eye problems

Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

Mylan enters into agreement with Gilead Sciences to manufacture, distribute Tenofovir Alafenamide

Clementia's palovarotene receives FDA Fast Track designation for FOP treatment

Cepheid gets FDA clearance to market Xpert Norovirus

CHFA reveals top five healthy holiday gift ideas

IMRIS successfully completes human factors study for SYMBIS Surgical System

Endomagnetics gets FDA's IDE approval to begin clinical trial of SentiMag and Sienna+ system

New book explores convergence as key to stable global agricultural platform

EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

Enhancing confidence in chemical ionization spectrometry data eBook

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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