Roche Investigated For NOT Reporting SIDE Effects!!!

Europe’s top drug regulator announced that it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs

If Roche is found guilty the company can be fined up to 5% of the price of their sales across the European Union

European Medicines Agency (EMA) announced that it is taking measures against the pharmaceutical manufacturer Roche which has not reported side effects of 19 of their medicines.
Eight of these drugs are used to treat cancers, including breast cancer. These include Avastin, Herceptin, Tarceva and Xeloda. Tamiflu is also listed.
British authorities draw the attention of European regulators to the problem in May when they see “serious deficiencies” in the reporting of side effects.
80,000 reports of adverse events submitted by users were not analyzed correctly. These include reports of 15,000 deaths, although it is unclear whether they are caused by drugs of Roche.
From EMA are calming down the consumers that they are not at increased risk. Authorities refused to describe what the side effects are, but only said that they are concerned of that they were not timely notified of them, which is a serious flaw in the system.
If Roche is found guilty the company can be fined up to 5% of the price of their sales across the European Union for the last year. The company’s shares lost 2 percent of its value on Tuesday when the scandal was announced.
The European Commission, the executive body of the EU, asked the European Medicines Agency to initiate criminal proceedings. A statement from the agency said that it will investigate the allegations against Roche.
EMA sends the manufacturer a detailed indictment list and is currently awaiting the response of the company. The investigation could take up to 18 months, after which the Commission must decide whether to impose sanctions.
Daniel Grotzky – Roche’s spokesman, said that the company is working with EMA to clarify the case and does not want to speculate on the subject. He said that patients’ safety is “of paramount importance”.

Source : dailyhealtharticles[dot]com

FDA Is Considering Faster Clinic Trials

The regulatory agency is considering a quick way of finding treatment for obese and develop life-saving antibiotics and other socially significant drugs

The new policy will allow the makers of such drugs to conduct smaller and faster clinical trials

Spokesman of the U.S. Administration of FDA Margaret Hamburg said that the regulatory agency is considering a quick way of finding treatment for obese and develop life-saving antibiotics and other socially significant drugs.
The new policy will allow the makers of such drugs to conduct smaller and faster clinical trials and to introduce the words “special medical use”, allowing physicians to grant experimental drugs in case of critical need. According to Ms. Hamburg, FDA should consider the needs of people with deadly or debilitating diseases that may be willing to take experimental drugs.
According to Alan Kuke – Deputy Director of Medical Programs at Pew Health Group, a new way of development, which would allow the product to reach the market faster and would make use only of patients with high risk / benefit would be a significant improvement. That would be good for manufacturers, patients and public health, he said.
Currently expedited consideration of clinical documentation is only available in a limited number of cases. Furthermore, although anti-cancer drugs are considered a priority, clinical trials have a normal period and number of volunteers.
Among the few companies enjoying an accelerated review of their products is Ziopharm, which are planning to develop and commercialize new anticancer therapies. The portfolio of the company consists of five products under study. Molecule in the most advanced stage – palifosfamid should hit the market at the end of 2012.

Source : dailyhealtharticles[dot]com