GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

    Physicians have been prescribing lower dose Cialis...off label... for a long time. The FDA finally agreed and approved it.

GlaxoSmithKline has gained a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX®. This likely means approval is 2-4 weeks away, but it could also mean months to years.

The study population is acceptably large, not based in Denmark – which is good there are not enough people there – so the study is worldwide and more representative of the Market this drug will reach. Payments to Lundbeck from Takeda are fair and agreeable. The clinical results for Phase II necessitate...

PRISTIQ can be expected to take massive market share from other Major Depressive Disorder (MDD) products. While Wyeth has lost little of its multi billion dollar market share when it collaborated with TEVA to market the IR and ER forms -- one can expect PRISTIQ to flatten the market out and control...

Loss of 1000 jobs in North America, Asia and Latin America and Southern America, USA. Expectations of $180 Million Dollar Savings.

study population size no evaluation for suicide and suicidal feelings

Rimonabant was studied for approval to exclude individuals with psychiatric disorders. Now, it is found that there is a link associated with rimonabant and severe psychiatric disorders to include increase risk of suicide.

GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) has sent a signal to the community.  It needs 2 years cash on hand and much less of its already small workforce.  This could imply the executives are preparing cushions for themselves when the firm folds. ...

E. Coli is a hazard to humans and can cause illness and death.  Once processing equipment is contaminated proper cleaning of the equipment can be hard.

Pharmaceutical lawsuits in the United States are costly.  In other places in the world and pharmaceutical lawsuit nearly a unicorn. There are three main players in these actions: The injured, the cause of injury, and the lawyers.