The News Review:
- Ethics & Clinical Trials: Debate hots up again
- Takeda Responds to the FDA Advisory Committee Recommendation.
- Jobs boost in life science sector
Ethics & Clinical Trials: Debate hots up again
Economic Times – Jul 30, 2007
Although Indian firmsdon?t pin their hopes on core discovery research at least for the timebeing many of them do realise that doing clinical trials for MNCs is aprofitable business. This is what really prompts them to pressure the governmentto further relax the clinical trial regulations. Pharma companies who have setup their own clinical research centres and a few number of stand-alone contractresearch organisations do a thriving business in India. For them the bar onconcurrent Phase I trial is often anirritant. n the issue ofsafety of clinical trials the risk persists more in relation to thesurreptitious trials done by doctors without informed consent of the patientthan the formal approved and regulated clinical trials. These unauthorisedtrials pose a grave threat to the people in a country like India where adherenceto medical ethics is a rarity. ?Even for approved clinical trials theinstitutional ethical committees are not regulated and made responsible for anywrongdoing? said CJ Shishoo an Ahmedabad-based medicinal chemist.
Takeda Responds to the FDA Advisory Committee Recommendation.
Free with registration – Business Wire – AccessMyLibrary.com – Jul 30, 2007
– Following a joint meeting today of the U. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Takeda Global Research & Development (TGRD) underscores its position that ACTS([R]) (pioglitazone HCl) offers a proven safety profile regarding the risk of cardiovascular disease. “The breadth and depth of ACTS data – encompassing more than 16000 patients over the past 10 years–is consistent: Short- and long-term studies both prospective and observational studies in both humans and animals all have shown no evidence that ACTS is associated with an increased risk of heart attack or stroke” said Mehmood Khan M. “Critical in this body of data is the PRactive (PRspective PioglitAzone Clinical Trial In MacroVascular Events) study.
Jobs boost in life science sector
BBC News – Jul 30, 2007
The expansion is being supported by a business grant from the Scottish Executive of £4. Fred Eshelman chief executive officer of PPD said: “Scotland offers both intellectual and technical resources that make it an important hub for our global clinical research operations. Enterprise Minister Jim Mather who was at the offices of PPD said he was delighted at the news. ‘Global player’He added: “The economic benefits of 390 jobs and a new facility not only impact on the local community but also make a very positive step towards increasing sustainable economic growth in Scotland. Jack Perry chief executive of Scottish Enterprise the economic development agency welcomed the “vote of confidence” in Scotland. He said: “This project represents a highly valuable and very welcome development for the life sciences sector in Scotland.
