Ethics/Regulatory

AstraZeneca files lawsuit against FDA regarding quetiapine

Wednesday, March 14, 2012 09:56 AM

AstraZeneca has filed a lawsuit against the FDA in district court to overturn the FDA’s denial on March 7, 2012, of citizen petitions filed by AstraZeneca with regard to Seroquel tablets and Seroquel XR extended release tablets (quetiapine fumarate).

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IOM report identifies ways to further improve pediatric studies

Friday, March 2, 2012 03:07 PM

Federal laws that motivate or require drug and biologic developers to conduct pediatric studies have yielded beneficial information to guide the use of medications in children, according to a new report by the Institute of Medicine (IOM).  Still, studies involving children continue to be limited, especially in certain areas such as medication use in newborns and long-term safety and effectiveness in children. 

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Arsenal Capital Partners acquires Western Institutional Review Board

Thursday, March 1, 2012 02:00 PM

Olympia, Wash.-based Western Institutional Review Board (WIRB), a privately held IRB, has been acquired by Arsenal Capital Partners, a New York-based private equity firm that invests in middle-market healthcare, specialty industrial and financial services companies.

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European Medicines Agency to start publishing info on drug applications

Wednesday, February 22, 2012 03:30 PM

Starting March 1, 2012, the European Medicines Agency will regularly publish information on applications for centralized marketing authorization for human medicines that it has received for evaluation.

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FDA to bolster supply of critically needed cancer drugs

Wednesday, February 22, 2012 02:03 PM

The FDA has announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. 

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Sen. Kay Hagan introduces TREAT Act to accelerate patient access to certain medicines

Friday, February 17, 2012 02:36 PM

Senator Kay R. Hagan (D-N.C.) has introduced the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, to get targeted treatments to patients with serious or life-threatening diseases in a quick and safe manner.

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Intellect Neurosciences to appeal in European patent proceedings

Wednesday, February 15, 2012 03:30 PM

Intellect Neurosciences, a biopharmaceutical company focused on disease-modifying therapeutic agents for Alzheimer's disease, submitted a statement setting out its grounds for appealing the European Patent Office's (EPO) preliminary decision to revoke the company's Antisenilin (bapineuzumab) patents.

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FDA seeks $4.5 billion FY 2013 budget

Tuesday, February 14, 2012 11:56 AM

The FDA is requesting a budget of $4.5 billion to protect and promote the public health as part of the president’s fiscal year 2013 budget—a 17% increase over the FDA enacted budget for FY 2012.

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FDA issues draft guidance on biosimilar product development

Thursday, February 9, 2012 01:58 PM

The FDA has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the U.S.

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European Commission and Mario Monti seek to increase patient access to generic medicines

Wednesday, February 8, 2012 10:06 AM

The European Generic Medicines Association (EGA) and Assogenerici, the Italian association for generic medicines, welcome the European Commission’s formal call on Italy to comply with European Union rules on the marketing authorization of generic medicines.

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