Over £220 million to boost innovation in the NHS
Filed in Fund raising, business, April 29, 2009, 9:07 amA £220 million fund will be made available to encourage innovation within the NHS, Health Minister Lord Darzi announced today, during an event at the Science Museum in London to mark the launch of ‘Innovation for a Healthier Future’, a series of initiatives to nurture and reward innovation within the NHS.
Free Strategy Consultation
Filed in sidenotes, April 28, 2009, 9:05 amFree Strategic Consultancy – Biotechnology Pharmaceutical regulatory development
New Draft FDA Guidance on Somatic Cell Therapy for Cardiac Disease
Filed in biotechnology, clinical, manufacturing, pre-clinical, regulatory, , 8:32 amThe FDA CBER (Centre for Biologics Evaluation and Research) has released some draft guidance for industry. it is intended to provide sponsors who are developing cellular therapies for the treatment of cardiac disease,
PhRMA Issues Revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results
Filed in clinical, regulatory, April 27, 2009, 8:58 amOn april the 20th the Pharmaceutical Research and Manufactures of Americal (PhRMA) issued a revised “Prinicples on Conduct of Clinical Trials and Communication of Clinical Trial Resutls”
Nonresponder phenomenon – a huge oportunity
Filed in Uncategorized, April 17, 2009, 4:19 pmMolecular diversity is part of life and as you know this impact in drug effectiveness considerable especially in the area of cancer, we all know that many oncology drugs will just not work in many patients but in those where they do work the effects are profound
Glaxo and Pfizer to Merge HIV Drug Units in New Company – Breaking News
Filed in business, April 16, 2009, 1:10 pmThis has just surfaced today, GlaxoSmithKlineplc and Pfizer inc plan to combine their HIV-drug units into a new company that will control almost 20 percent of hte market for anti-HIV drugs.
FDA go Mystery Shopping
Filed in clinical, regulatory, April 15, 2009, 9:07 amThe FDA has decide to monitor the quality of the decisions being made by some IRB’s in commercial research institutes, in what appears to be a break from the normal methods of Audit, where they review past decisions, in the case of Coast, a for profit Independent review board, the FDA submitted a bogusclinical trial protocol
Expertise Recognised
Filed in sidenotes, April 14, 2009, 10:25 amwww.damienbove.com is now published on EzineArticles where we are recognised as Expert Authors in the Area of Pharmaceutical Development Consultants.
Priority Review Vouchers – and there off
Filed in clinical, regulatory, April 9, 2009, 9:16 amYesterday the FDA announced the approval of Norvartis’ combination drug product Coartem (artemether, lumefanterine) for the treatment of acute uncompliacted malaria infections in adults and children weighing at least five killigrams, and the FDA has awarded them a priority review voucher
Pediatric Exclusivity After Product Approval; FDA Interpriations About Which You Might Not Be Aware
Filed in clinical, regulatory, April 8, 2009, 9:18 amthe FDA grants an additional period of exclusivity for a licensed product for a period of 6 months, if the sponsor submits requested information relating to the use of the active moiety in the paediatric population. There are a number of rules and regulations involved in obtaining this exclusivity
