US

Showing 15 posts of 324 posts found.

Coast first casualty in US overhaul of IRB system

May 5, 2009
Research and Development FDA, US

A US company offering institutional review board services to sponsors of clinical trials has been forced to close its doors …

Committee approves limited use of Seroquel in depression

April 9, 2009
Research and Development, Sales and Marketing AZ, Seroquel, US

An FDA advisory committee has concluded that safety concerns mean that Seroquel XR should not be used to treat anxiety, …

US prescription growth stalls in 2008

April 3, 2009
Sales and Marketing US

US prescription sales growth was just 1.3% in 2008, well down on the typical 5%-plus in recent years, according to …

Biosimilars: time for an approval pathway in the US

March 23, 2009
Research and Development, Sales and Marketing US, generics

Congress has received another bill seeking to establish a biosimilars approval pathway in the US. HR 1427 represents the latest …

Sanofi boosted by Multaq vote of approval

March 19, 2009
Research and Development, Sales and Marketing FDA, Multaq, Sanofi, US

An FDA committee has recommended Sanofi-Aventis' new atrial fibrillation treatment Multaq, the company's most important late-stage drug. The FDA cardiovascular …

Biosimilars bill offers 12 years’ marketing exclusivity

March 19, 2009
Research and Development US, generics

The US moved one step closer to creating a market for biosimilars – substitutable versions of branded biologic drugs – …

Obama ends stem cell funding ban

March 10, 2009
Research and Development US, stem cell

President Obama has lifted the US ban on federal funding for new stem cell research, signalling another marked departure in …

Obama makes ‘downpayment’ on US healthcare reform

March 5, 2009
Research and Development US, healthcare

President Barack Obama has reiterated his aim of bringing universal healthcare to the US and has put a $76.8 billion …

R&D tax credits among anticipated changes for US healthcare

February 24, 2009
Research and Development US, healthcare

With the election of Barack Obama, widespread changes are anticipated for US healthcare and ultimately for the pharmaceutical industry. Although …

FDA finalises transgenic animals guide

January 23, 2009
Research and Development, Sales and Marketing FDA, US, reg

The route map for companies wishing to sell medicines made in genetically-engineered animals has been drawn up by the FDA. …

Declaring doctor payments

December 16, 2008
Research and Development, Sales and Marketing ABPI, EFPIA, Europe, UK, US, ethics, industry relations, payments

A number of pharmaceutical companies in the US have recently announced they will declare all the payments to healthcare professionals. …

Preparing for the US generics boom

December 15, 2008
Sales and Marketing US, generics

One of Barack Obama's key goals as president is to reduce healthcare costs, particularly those related to prescription medications, by …

MedImmune’s respiratory treatment faces US approval delay

December 3, 2008
Sales and Marketing US, reg, resp

One of MedImmune's key products has hit a delay in the US, after regulators demanded further data. The FDA asked …

Hope for Obama’s healthcare IT plan

December 1, 2008
Sales and Marketing US, hc, reform

The election of Barack Obama has brought high expectations, with his "Change Can Happen" mantra signaling to many that a …

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