Ethics/Regulatory

EMA restricts former chief’s activities

Wednesday, March 23, 2011 12:03 PM

Former EMA executive director Thomas Lonngren is facing regulatory issues regarding his plans to consult for pharma companies.

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Bayer Healthcare's Stephen Klincewicz speaks on global pharmacovigilance regulations

Friday, March 18, 2011 01:03 PM

Conference producing company marcus evans has interviewed Stephen L. Klincewicz, global head of drug safety for Bayer Consumer Care, in advance of its upcoming Global Pharmacovigilance and Adverse Event Reporting Forum, May 11-13^th in Philadelphia. Klincewicz will be speaking at the conference, which brings together industry executives to examine how to develop innovative methods of signal detection and mitigating adverse events. http://bit.ly/gu9L5E

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Lilly CEO confident in FDA approval

Monday, March 14, 2011 01:31 PM

Eli Lilly CEO John Lechleiter said he's confident of gaining U.S. regulatory approval for a drug to help identify plaque in the brain associated with Alzheimer's disease, according to a Bloomberg News report.

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Study: Current regulations give IRBs insufficient guidance to protect trial subjects with dementia

Monday, March 7, 2011 08:05 AM

Since dementia patients and others with limited decision-making capabilities cannot defend their own interests when participating in a clinical trial, researchers and ethicists have called for policy-makers and stakeholders to develop concrete ethical and legal guidelines to protect this population.

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Ohio may require drugmakers to disclose gifts to doctors

Wednesday, March 2, 2011 01:46 PM

Ohio may become the next state to require drugmakers to report gifts they give to doctors, according to Pharmalot. However, the bill, which was introduced in the state Senate, effectively mirrors a provision of health care reform that is scheduled to go into effect in 2013. The Ohio legislation does not pertain to device makers.

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Former EMA director's new position raises conflict of interest questions

Wednesday, March 2, 2011 08:14 AM

The European Medicines Agency (EMA)’s decision to allow its former executive director, Thomas Lonngren, to take up an advisory role within the private pharmaceutical sector—just weeks after leaving his position at EMA—risks conflicts of interest, campaigners have claimed.

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FDA approves Promacta

Tuesday, March 1, 2011 01:10 PM

GlaxoSmithKline said the FDA has granted full approval for Promacta (eltrombopag), an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

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Daiichi Sankyo acquires Plexxikon

Tuesday, March 1, 2011 12:35 PM

In another sign that biotechnology companies with promising pipelines are able to forge rich buyout deals, Japanese pharmaceutical company Daiichi Sankyo has announced it will pay $805 million upfront and up to $130 million in near-term milestones for Plexxikon, a tiny oncology developer, according to Fierce Biotech.

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FDA issues warning letter to Sanofi-aventis

Tuesday, March 1, 2011 08:00 AM

The FDA has warned Sanofi-Aventis’ U.S. unit for failing to submit reports of possible serious drug side effects in a timely manner. In a Jan. 28 letter made public last week, the FDA said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

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Technology companies adapt interactive video concepts for clinical trial informed consent

Monday, February 14, 2011 10:15 AM

Interactive videos, complete with soothing voices, explain hospital surgeries step-by-step, along with the risks and benefits, to enable patients to make informed decisions. Now, producers of these videos are adapting them for the clinical trials space, which for decades has relied on paper documents that often fail to adequately inform prospective volunteers.

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