Search Results for "Odac Marqibo 2012"

21:18 EDT 30th June 2015 | BioPortfolio

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macitentan

Macitentan (Opsumit®) is a novel dual endothelin receptor antagonist (ERA) that resulted from a tailored drug discovery process with the target to develop an ERA optimized for efficacy and safet...

ATX-MS-1467 for patients with multiple sclerosis (MS)

ATX-MS-1467 is a novel treatment that was developed with the aim of working with the immune system to treat the underlying cause of disease rather than just treating the symptoms or suppressing the ...

Coronavirus

Coronavirus were first identified in the 1960s, and were named after the crown-like projections on the surface of the virus. They cause respiratory infections in both humans and animals. Coronavir...

Veregen

Veregen® is an ointment used to treat external genital warts. In the USA, Germany, Austria, Spain, Switzerland and Serbia, Veregen® is already marketed by our partners. Sales and marketing p...

PATHSEEK

Sequencing platforms in diagnostic laboratories may aid both patient management by detecting resistance associated mutations, and public health measures, by determining phylogenetic relationships be...

Matching News

Latest News From "The Pink Sheet" DAILY - Aveo's Tivozanib Faces ODAC May 2

Aveo's Tivozanib Will Face Challenging Survival Data At ODAC Review FDA's Oncologic Drugs Advisory Committee will consider the tyrosine kinase inhibitor for advanced renal cell carcinoma at a May 2 me...

From Advisory Committee to Approval: FDA Makes Move to Approve a First US Biosimilar Medicine

The Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), on March 6, 2015, making for a quick approval decision following the January 7, ...

No FDA panel bodes well for Pfizer's palbociclib

But with no ODAC, the decision could potentially come sooner.

Orlando Dermatology Aesthetic and Clinical Conference The perfect balance of medical and aesthetic training WATCH IT LIVE! January 16-19, 2015

ORLANDO, Fla., Jan. 16, 2015 /PRNewswire/ -- For twelve years, the ODAC educational program has presented progressive medical, surgical, and cosmetic techniques delivered by the foremost thought ...

Advising the advisors

FDA used the Zarxio review to educate the public and ODAC about how to review biosimilars data. Naming and interchangeability remain up in the air.

FDA's 1st biosimilar adcomm: a lovefest

She also expressed her delight the ODAC had not convened a day earlier, when Washington was hit by an icy-cold snowstorm, which snarled traffic, and may have prevented the attendance of the other high...

FDA Panel Recommends Novartis' Biosimilar Filgrastim

BASEL (dpa-AFX) - Sandoz, a Novartis (NVS) company, announced that US Food and Drug Administration Oncologic Drugs Advisory Committee or ODAC recommended approval of its investigational biosimilar...

The Education Of ODAC: How Sandoz Made Its Case For Biosimilarity

As the first biosimilar sponsor to present at an advisory committee, Sandoz had to educate FDA’s external experts about the general concepts of biosimilarity and the specific data surrounding its Za...

Matching PubMed Articles

Influenza in Poland in 2011-2012 and in 2011/2012 and 2012/2013 epidemic seasons.

This paper aimed at evaluating the epidemiological situation of influenza in Poland in 2011-2012 and in 2011/2012 and 2012/2013 epidemic seasons and comparing it with the situation observed in the pre...

Drinking Patterns in US Counties From 2002 to 2012.

We estimated the prevalence of any drinking and binge drinking from 2002 to 2012 and heavy drinking from 2005 to 2012 in every US county.

Registered report: Transcriptional amplification in tumor cells with elevated c-Myc.

The Lin et al. (2012), published in Cell in 2012. The experiments that will be replicated are those reported in Figures 3E and 3F. In these experiments, elevated levels of c-Myc in the P493-6 cell mod...

Trends in Elevated Triglyceride in Adults: United States, 2001-2012.

The percentage of adults aged 20 and over with elevated triglyceride (150 mg/dL or more) declined from 33.3% during 2001-2004 to 25.1% during 2009-2012. Percentages with elevated triglyceride decrease...

(13)C Nuclear Magnetic Resonance and Electron Paramagnetic Spectroscopic Comparison of Hydrophobic Acid, Transphilic Acid, and Reverse Osmosis May 2012 Isolates of Organic Matter from the Suwannee River.

Dissolved organic matter (DOM) is found in most natural waters at concentrations low enough to make DOM isolation methodologies critical to full analytical characterization and preservation. During th...

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