Ethics/Regulatory

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The National Institute for Health and Clinical Excellence (NICE), the U.K. healthcare guidance body, has issued new draft guidance not recommending the use of Zytiga (abiraterone), developed by Janssen, in combination with prednisone or prednisolone for the treatment of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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FDA approves Erivedge to treat skin cancer

Monday, January 30, 2012 04:02 PM

Genentech’s Erivedge (vismodegib) has been approved by the FDA to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

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FDA’s CDRH sets goals for personalized medicine

Tuesday, January 24, 2012 02:51 PM

The FDA's Center for Devices and Radiological Health has set personalized medicine as one of its priorities for the current year, aiming for draft guidance on co-development of drugs and diagnostics by year's end.

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FDA includes social media in advertising guidance

Tuesday, January 24, 2012 02:45 PM

The FDA has issued a final guidance for industry product name placement, size and prominence in advertising and promotional labeling, including juxtaposition of proprietary and established product names.

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FDA approves label change for Tysabri

Tuesday, January 24, 2012 10:48 AM

The FDA has approved a product label change for Biogen Idec/Elan’s Tysabri that will help enable individual benefit-risk assessment for patients with multiple sclerosis (MS).

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Irish-based pharma firms now have stricter marketing code

Friday, January 20, 2012 10:46 AM

Pharmaceutical companies in Ireland may no longer use well-known entertainment or other leisure activity venues to promote their products to health professionals, new guidelines have stated.

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FDA completes recommendations for three user fee programs

Wednesday, January 18, 2012 12:18 PM

The FDA completed its recommendations Jan. 17 for three user fee programs to help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients.

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FDA holds J&J under magnifying glass

Friday, January 13, 2012 01:34 PM

The FDA has trained a watchful eye on Johnson & Johnson as delayed reports, recalls and court trials pile up.

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