GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

This new medicine should reduce the side affects of standard SEROQUIL now regularly prescribed. This extended release form will be a life cycle management tool to keep market share.

1. The results are intriguing, but the clinical relevance for the large number of patients who could be exposed in the real-life clinical situation is uncertain. 2. The hypotheses for thsi program early-on seem to be supported by the phase 3 data to date, i.e., the nitro-comopounds may have actions...

1. Metastatic melanoma in Stage IV is difficutl to treat. 2. Previous interventions have proven almost worthless 3. The succesful SPA agreement is an important regulatory step for the program. 4. Data will take years to develop, validate, and translate into an approved product.

Stiefel Laboratories, Inc has largely old equipment and can use a boost from Allergan, Inc reported to have more modern manufacturing and testing equipment, this will aide in production and approvals by regulatory agencies.

The content uniformity Chapter 905 of the USP United States Pharmacopeia makes clear the limits for non-uniformity and another chapter concerns itself with drug potency.  These two components are widely recognized as critical standards for drug products to meet.

These privately held companies as joined have great assets on the market now and significant sales.  Bradley Pharmaceuticals is very likely a thing to make Nycomed stronger.

Don’t look to the FDA for answers about ixempra look instead to Bristol-Myers Squibb Co (BMY.N: Quote, Profile, Research) instead.

1) Generic Drugs are not the same as branded (Ethical) products. 2) Sometimes the branded drug is not the same as the bio-batch 3) In both cases sometimes it matters for the patient and in other cases it may not.

Lilly stands to keep focus on Type I diabetes.

This announcement indicates that clinical development can now proceed under the IND for all outstanding and recently submitted protocols. It does not mean that the initial reason for clinical hold has been fully satisfied throughout the rest of the clinical development program. That will be dtermined...