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While the FDA stayed true to its previous advice in the three draft biosimilars guidances released earlier this month, experts appear in conflict over how “abbreviated” the approval pathway is.

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

FDA Reviewer Recommends Against Chelsea Hypotension Drug Approval

Chelsea Therapeutics’ low blood pressure drug Northera should not be approved as it has failed to show long-term benefit and is fraught with safety concerns, an agency reviewer says in the run up to the drug’s Thursday advisory panel meeting.

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

Guidance Details Mandatory, Voluntary Reporting Requirements for Drug Shortages

Drugmakers should voluntarily notify the FDA of product quality problems, manufacturing interruptions and delays in acquiring raw materials to help prevent drug shortages, the agency says in draft guidance issued Tuesday.

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

Industry Appeals to CMS for a More Streamlined Sunshine Act

A proposed Sunshine Act reporting rule for drugmakers and group purchasing organizations (GPOs) is overly burdensome, contravenes congressional intent and may result in corporate reports that further cloud industry relationships with doctors and hospitals, Big Pharma says.

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

Sandoz’s Canadian Plant Pauses Production After FDA Finger Wag

Three months after the FDA flagged three manufacturing plants operated by Sandoz for quality control issues, the Novartis subsidiary has temporarily suspended generic drug production and discontinued some products at its Boucherville, Quebec, facility to address the agency’s concerns.

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

Novartis Jumps on Hep C Bandwagon With Enanta Collaboration

Novartis is staking a claim in an increasingly competitive and crowded hepatitis C field, acquiring Enanta’s HCV drug EDP-239 for $34 million.

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

Florida company aims to spend $300 million for physician practices

Mednax is making plans for a major buying spree after a slowdown in 2011.

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Last Updated (Tuesday, 30 November 1999 00:00) 21 February 2012

Roche Melanoma Drug Zelboraf Wins EU Approval

Six months after receiving a stateside nod, Roche has secured EU approval for its metastatic melanoma treatment Zelboraf, and analysts say it is emerging as the dominant therapy in patients with the BRAF V600E mutation.

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Last Updated (Tuesday, 30 November 1999 00:00) 20 February 2012

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Last Updated (Tuesday, 30 November 1999 00:00) 20 February 2012

Teva Withholds NDA for MS Drug Laquinimod Following FDA Talks

After recent discussions with the FDA, Teva Pharmaceuticals has decided not to file an NDA for relapsing remitting multiple sclerosis (RRMS) treatment laquinimod but plans to keep developing and studying the drug.

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Last Updated (Tuesday, 30 November 1999 00:00) 20 February 2012

Final Guidance: Include More than 100 Geriatric Patients in Late-Stage Trials

Drugmakers should consider including more than 100 geriatric patients in Phase II and III databases for new drugs to account for the increasing prevalence and complexity of the elderly patient population, according to a final International Conference on Harmonisation (ICH) guidance adopted by the FDA.

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Last Updated (Tuesday, 30 November 1999 00:00) 20 February 2012

Cushing’s Syndrome Drug Korlym Nabs Disease’s First FDA Approval

The FDA has approved Corcept Therapeutics’ orphan drug Korlym to control high blood sugar in Cushing’s syndrome patients — the first agency-accepted treatment for the rare disease.

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Last Updated (Tuesday, 30 November 1999 00:00) 20 February 2012