Ethics/Regulatory

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FDA issues draft guidance on biosimilar product development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The FDA has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the U.S.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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NICE refuses to recommend Janssen’s Zytiga for prostate cancer

Wednesday, February 8, 2012 09:58 AM

The National Institute for Health and Clinical Excellence (NICE), the U.K. healthcare guidance body, has issued new draft guidance not recommending the use of Zytiga (abiraterone), developed by Janssen, in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed on or after docetaxel-containing therapy.

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New bipartisan legislation to address prescription drug shortages

Monday, February 6, 2012 01:58 PM

U.S. Representatives John Carney (D-Del.) and Larry Bucshon (R-Ind.) introduced the Drug Shortage Prevention Act Jan. 31, which addresses the scarcity of certain pharmaceutical drugs in the marketplace.

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Pew Health urges Congress to reauthorize PDUFA

Monday, February 6, 2012 08:38 AM

Allan Coukell, director of medical programs at the Pew Health Group, issued a statement concerning a U.S. House energy and commerce subcommittee on health hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA IV), which has shortened the pharmaceutical approval process by the FDA.

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