Derek Lowe writes at In the Pipeline that Novartis and Roche are so displeased with the government's approach to drug pricing and
regulations on clinical trials that they are threatening to pull their R&D out of the country.
Not exact matches
Constantly changing and often inconsistent
regulations, chaotic reimbursement policies, lack of insurance coverage of routine care associated with
clinical trials, increasing demands
on physician time, and scientific advances demonstrating the complex differences between individual patients, all complicate
clinical research in both benign and malignant hematology.
These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and
clinical development of pharmaceutical products, including the identification of compounds and the completion of
clinical trials, the effect of government
regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence
on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report
on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports
on Form 10 - Q or Current Reports
on Form 8 - K.
The human tissue act, all the animal
regulations, especially concerning transgenic mice and the colossal amount of
regulations and paperwork in
clinical trials, all of these have had a chilling effect
on research and more and more human and animal research has moved to less regulated environments.
These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and
clinical development of pharmaceutical products, including the identification of compounds and the completion of
clinical trials, our ability to form collaborative relationships, the effect of government
regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence
on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report
on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports
on Form 10 - Q or Current Reports
on Form 8 - K.
These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, the outcome of the review of the continued listing of our common stock
on The Nasdaq Stock Market, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and
clinical development of pharmaceutical products, including the identification of compounds and the completion of
clinical trials, our ability to form collaborative relationships, the effect of government
regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence
on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report
on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports
on Form 10 - Q or Current Reports
on Form 8 - K.
In China, where
regulations on gene editing are less tightly controlled, there are already several CRISPR
clinical trials underway.
The UK has been leading conversations
on clinical trial transparency and can not afford to be left behind when it comes to
regulation.
That would be a health claim — and a flagrant violation of Food and Drug Administration
regulations forbidding health claims
on products that haven't been proven with clear - cut scientific evidence, meaning research and
clinical trials conducted according to strict protocols.
Clinical Project Managers usually work for pharmaceutical companies where they coordinate assigned clinical trials and complete tasks such as ensuring that projects are completed on time and within budget, creating timelines for each project, preparing documents, reviewing project tasks, handling budgets, and ensuring compliance with industry procedures and regu
Clinical Project Managers usually work for pharmaceutical companies where they coordinate assigned
clinical trials and complete tasks such as ensuring that projects are completed on time and within budget, creating timelines for each project, preparing documents, reviewing project tasks, handling budgets, and ensuring compliance with industry procedures and regu
clinical trials and complete tasks such as ensuring that projects are completed
on time and within budget, creating timelines for each project, preparing documents, reviewing project tasks, handling budgets, and ensuring compliance with industry procedures and
regulations.