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GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

July 25, 2007
ALZHEMED will have close FDA contact to speed the review of the drug for political reasons established by Congress.
By a GLG Expert Contributor
Analysis of: Neurochem granted fast track designation from U.S. FDA for tramiprosate (ALZHEMED(TM)) (www.pipelinereview.com)
A few things that can be counted on from the FDA: 1) The review will likely be less diligent. 2) The review will be based upon statistical modeling as agreed upon by Neurochem Inc and the FDA.
July 25, 2007
Evista is a good option for use in Breast Cancer
By a GLG Expert Contributor
Analysis of: FDA Panel Recommends Osteoporosis Drug Evista For Breast Cancer Prevention (www.medicalnewstoday.com)
The medication, like virtually all drugs has some side effects, and will be used under a doctor and pharmacist care to minimize these problems. Otherwise this product looks like it will be approved by the FDA and another tool against breast cancer.
July 25, 2007
Isotechnika Inc. gains enough patients for Phase III clinicals, good news, required news.
By a GLG Expert Contributor
Analysis of: Isotechnika completes patient recruitment of pivotal Phase 3 psoriasis trial (www.pipelinereview.com)
Isotechnika Inc. gains enough patients for Phase III clinicals. This information is good news in so far as it permits the company to move forward with Research and Development and progress to launch. But, by the same token to get a drug to market securing patients is a normal function so such news is...
July 24, 2007
Why are Generic's Killing Innovative Branded Drugs
By a GLG Expert Contributor
Analysis of: Pfizer Signals More Cuts as Net Falls; Abbott Profit Rises 62% on Humira (online.wsj.com)
A book can be written as to how hazardous to drug development the generic pharmaceutical industry actually is.
July 24, 2007
Aripiprazole sNDA expected to have fast approval for Bi Polar I
By a GLG Expert Contributor
Analysis of: ABILIFY(R) (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder (www.pipelinereview.com)
The Supplemental New Drug Application, sNDA, is likely to be approved as most sNDA’s have a high degree of probability for approval when in this status. It is likely viable treatment, but may not be the best.
July 24, 2007
FDA will accept the advisory panel's decision, though it is not required to do so. Evista, an osteoporosis drug is likely to win the approval is seeks.
By a GLG Expert Contributor
Analysis of: FDA will weigh Evista's cancer-reducing benefits (www.usatoday.com)
The FDA will likely always approve the advisory panels decision. Lilly will have more data to present than the so called two women's health advocacy groups who without data will lose in argument.
July 24, 2007
Takeda's TAK-491 for Treatment of Hypertension remains a hopeful.
By a GLG Expert Contributor
Analysis of: Takeda's Investigational Compound TAK-491 for Treatment of Hypertension Enters into Phase 3 Clinical Stage in the U.S. and Europe (www.pipelinereview.com)
The claims made by Takeda are powerful, but only after one or more phase III clinical will the firm be able to affirm the claims.
July 20, 2007
Sleep Apnea device good for some not for others
By a GLG Expert Contributor
Analysis of: Sleep apnea device may improve patient outcome (www.reuters.com)
Who would gain from a device that requires once to carry around a bulky oxygen tank vs using simple air?
July 12, 2007
Chantix is a concept now, at Phase III all the investors will want to be in the know.
By a GLG Expert Contributor
Analysis of: Anti-smoking drug Chantix works for alcohol too (www.news-medical.net)
These clinical studies are in rats, pigs might be a better model in most cases for humans, but in either case it is not know to be tested on one person. When human data is generated then there may be important progress.
July 12, 2007
Pfizer on a come back: Fast Track Review for a Drug used in 5 Million Worldwide already
By a GLG Expert Contributor
Analysis of: Pfizer’s Lyrica Receives FDA Approval for Fibromyalgia (www.medadnews.com)
Pfizer has selected a drug, Lyrica® (pregabalin) capsules CV, with a good market base, one that qualified to be on the fast track for FDA approval - which most likely cut development costs, and the drug has been in 5M people already without press reviews of it causing harm. The review cites patient...

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