Regulatory and Legal
Search Results 71 - 80 of 157 recordsFDA Approves New HIV Drug After Priority Review
(Top News, 24 Jan 2008 )The US Food and Drug Administration today approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals. Etravirine is a non-nucleoside ....
Study: Aggressive TB Control Can Yield Big Economic Gains
(Top News, 23 Jan 2008 )A new World Bank research report finds that 22 countries with the world's highest numbers of TB cases could earn significantly more than they spend on TB diagnosis and treatment if they signed onto a ....
The GVK BIO Clinical Pharmacology Unit Granted Major Accreditations
(Top News, 15 Jan 2008 )The Clinical Pharmacology Unit (CPU) of GVK Biosciences (GVK BIO) received approvals from all major regulatory bodies globally including USFDA, AFSAAPS, WHO and ANVISA. The approvals open global markets ....
FDA Clears First Test Designed To Detect And Identify 12 Respiratory Viruses From Single Sample
(Top News, 08 Jan 2008 )The US Food and Drug Administration has cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses. The test, called the xTAG Respiratory Viral Panel, is the ....
FDA Receives New Data On Risks Of Anemia Drugs
(Business News, 07 Jan 2008 )The US Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies ....
Managing A Triangle Relationship
(Drug Manufacturing, Jan 2008 )In a Marcus Evans conference in Singapore entitled Managing R&D Outsourcing and Partnering held in August 2007, Ho Cheng Huat, executive vice president of the Intellectual Property Management Division ....
Innovative Packaging Receives Award from World Packaging Organization
(Global News, Jan 2008 )Bosch Sigpack Systems, a Bosch packaging technology company, received the prestigious Packaging Award WorldStar 2007 from the World Packaging Organization for its packaging concept Burgopak. A total of ....
Stem Rotavirus Through Wider Vaccination
(Editor's Note, Jan 2008 )Prevailing rotavirus disease among children is uniting global institutions and organizations to push for greater incidence of rotavirus vaccination. This was clearly seen at the 5th World Congress of ....
Regulation of Pharma Excipients in Europe: Implications for Manufacturers and Suppliers
(Policy & Projections, Jan 2008 )Pharmaceutical manufacturers and their excipient suppliers are facing an uncertain future with the formal introduction of Good Manufacturing Practice (GMP) requirements in the European Union. However, ....
PATH Study: $2-10B Needed For Vaccine Access For Influenza Pandemic Preparedness
(Top News, 21 Dec 2007 )If an influenza pandemic occurred in 2007, fewer than one-fifth of the approximately 13 billion vaccine doses needed to fully vaccinate the global population would be available within six months in a ....
