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Eisai Announces Availability of BELVIQ® (lorcaserin HCl) CIV Tablets for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese BELVIQ Available in U.S. Pharmacies within One Week

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New Drug Approvals

LORCASERIN

june 7, 2013 –Eisai Inc. announced today that BELVIQ (pronounced BEL-VEEK) will be available to eligible patients by prescription in the United States beginning June 11.

 

BELVIQ was approved by the U.S. Food and Drug Administration on June 27, 2012 to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes.  It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes your risk of heart problems or stroke, or of death due to heart problems or stroke.

 

“BELVIQ is a new treatment option…

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Curriculum Vitaes in Training Records

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Inspired Pharma Blog

I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records.  This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.CV1

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Should You be Taking Supplements?

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Long Live Food- Holistic Health Counseling

I get asked this all the time, “what do you think about supplements?”  While there is much debate about whether or not vitamins and minerals are necessary to take in a daily pill form, some people approach supplementing with the thought, “well, it can’t hurt!” Image

The thing is, unfortunately there are many not-so-great brands of vitamins and minerals.  What makes them bad?  Well for one, they can be contaminated, and two, the forms of minerals can be hard to digest and absorb, making some supplements a complete rip off.

However, even if you are eating fruits and veggies each day, you are most likely missing out on some major vitamins and minerals for your body. Thus, supplementing can help you catch up on some important vitamin and mineral deficiencies.

Many health counselors, like me, often recommend the following supplements:

  • A fish oil, krill oil, or flaxseed oil:…

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A Second Look – The Best GMP Contracts

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Oh, By The Way...

There are firms that promote various Guaranteed Maximum Price (GMP) contracts. Why?

In order to have a true GMP contract one needs to develop the design, issue the documents for bidding and then having the work performed without any or a minimal amount of change orders.  This concept sounds a lot like the traditional design, bid and build construction – which is the most cost effective method to deliver a project.

On GMP contracts it is not unheard of for the project costs to balloon way past the estimated project costs.  Why does this happen?  Because the design requirements were not finalized prior to issuing the documents and the most costly time to fix design or construction problems is during the construction period.

Changes to the scope during construction will create cost increases and delays that must be compensated for during the construction period.  While owners and developers maybe hoping…

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