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| Shire Receives FDA Approvable Letter For INTUNIV (guanfacine) ER, A Nonstimulant ADHD Treatment |
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) has announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective alpha-2A-receptor agonist that has been studied in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
2007-06-24 14:00 |
| Sandoz Receives Positive EU Opinion For Approval Of Epoetin Alfa Biosimilar |
Sandoz is the first company to receive a positive opinion from European Union regulators supporting the approval of a biosimilar version of epoetin alfa, achieving another important milestone in its efforts to bring follow-on biological medicines to patients. More than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, and similar medicines to regulate the formation of red blood cells.
2007-06-24 02:00 |
| Rules And Guidance For Pharmaceutical Distributors 2007, UK |
The Rules and Guidance for Pharmaceutical Distributors reproduces those elements of the 2007 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (commonly known as the "Orange Guide") specific to the wholesale supply and distribution of medicines for human use.
2007-06-23 03:00 |
| EMEA-FDA Regulatory Cooperation Expanded |
The US Food and Drug Administration (FDA), the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several important areas. At a meeting June 14-15, 2007, the US and the EU reviewed the past year's activities under the existing Implementation Plan for the confidentiality arrangement.
2007-06-20 03:00 |
| Prescription And Over-The-Counter Diet Pills May Increase Unhealthy Behavior |
Glaxo Smith Kline's Alli™, the first FDA-approved over-the-counter weight loss pill, has hit shelves nationwide. Whether or not it succeeds depends a large part on its multilingual, multi-million dollar marketing campaign. A new study by Wharton professors and doctors at the University of Pennsylvania School of Medicine provides applicable new insight into consumer thinking about health remedies.
2007-06-19 10:00 |
| MHRA Second Communications Strategy Published, UK |
The MHRA is responsible for safeguarding public health by making sure that medicines and medical devices work, and are acceptably safe. If it is to be successful in this mission, the Agency must effectively communicate accurate and timely information about the benefits and risks of medicines and medical devices to key stakeholders, including the public, patients, healthcare professionals, researchers and industry.
2007-06-19 03:00 |
| Biotechnology And The EU - Speech By Peter Mandelson, EU Trade Commissioner |
In this speech to the European Biotechnology Open day in Brussels EU Trade Commissioner Peter Mandelson strongly defends an open European approach to biotechnology and GM food; one that prioritises strict science-based health and safety testing but which recognises that safe biotechnology has a crucial role to play in agriculture and agricultural trade both in Europe and the developing world.
2007-06-16 03:00 |
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