AstraZeneca Seroquel for depression setback

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AstraZeneca in treatment setback

http://www.google.com/hostednews/ukpress/article/ALeqM5gmUl6w2MgU_OuDNAxIM85r4fOiPQ

2 hours ago

Drugs giant AstraZeneca saw shares come under pressure after fears of potential delays in an application to US regulators over its Seroquel treatment.

The US Food and Drug Administration (FDA) has asked for further information over the firm's supplemental application for Seroquel to be approved as a treatment for major depressive disorder (MDD) in adults.

Seroquel already has FDA approval for schizophrenia and bi-polar disorder, but analysts said the request for information could lead to a two-year delay. Shares in the firm fell 2%.

Panmure Gordon's Tom Kemp said the FDA's decision "represents another setback for the company's pipeline" although Seroquel still represented a "major opportunity" for AstraZeneca.

But he added: "We hope the company will be able to provide the answers the regulator requires without the need for new trials. If new trials are required then this setback could be a two year delay."

[Guest guest]

AstraZeneca in treatment setback

http://www.google.com/hostednews/ukpress/article/ALeqM5gmUl6w2MgU_OuDNAxIM85r4fOiPQ

2 hours ago

Drugs giant AstraZeneca saw shares come under pressure after fears of potential delays in an application to US regulators over its Seroquel treatment.

The US Food and Drug Administration (FDA) has asked for further information over the firm's supplemental application for Seroquel to be approved as a treatment for major depressive disorder (MDD) in adults.

Seroquel already has FDA approval for schizophrenia and bi-polar disorder, but analysts said the request for information could lead to a two-year delay. Shares in the firm fell 2%.

Panmure Gordon's Tom Kemp said the FDA's decision "represents another setback for the company's pipeline" although Seroquel still represented a "major opportunity" for AstraZeneca.

But he added: "We hope the company will be able to provide the answers the regulator requires without the need for new trials. If new trials are required then this setback could be a two year delay."

[Guest guest]

AstraZeneca in treatment setback

http://www.google.com/hostednews/ukpress/article/ALeqM5gmUl6w2MgU_OuDNAxIM85r4fOiPQ

2 hours ago

Drugs giant AstraZeneca saw shares come under pressure after fears of potential delays in an application to US regulators over its Seroquel treatment.

The US Food and Drug Administration (FDA) has asked for further information over the firm's supplemental application for Seroquel to be approved as a treatment for major depressive disorder (MDD) in adults.

Seroquel already has FDA approval for schizophrenia and bi-polar disorder, but analysts said the request for information could lead to a two-year delay. Shares in the firm fell 2%.

Panmure Gordon's Tom Kemp said the FDA's decision "represents another setback for the company's pipeline" although Seroquel still represented a "major opportunity" for AstraZeneca.

But he added: "We hope the company will be able to provide the answers the regulator requires without the need for new trials. If new trials are required then this setback could be a two year delay."

[Guest guest]

AstraZeneca in treatment setback

http://www.google.com/hostednews/ukpress/article/ALeqM5gmUl6w2MgU_OuDNAxIM85r4fOiPQ

2 hours ago

Drugs giant AstraZeneca saw shares come under pressure after fears of potential delays in an application to US regulators over its Seroquel treatment.

The US Food and Drug Administration (FDA) has asked for further information over the firm's supplemental application for Seroquel to be approved as a treatment for major depressive disorder (MDD) in adults.

Seroquel already has FDA approval for schizophrenia and bi-polar disorder, but analysts said the request for information could lead to a two-year delay. Shares in the firm fell 2%.

Panmure Gordon's Tom Kemp said the FDA's decision "represents another setback for the company's pipeline" although Seroquel still represented a "major opportunity" for AstraZeneca.

But he added: "We hope the company will be able to provide the answers the regulator requires without the need for new trials. If new trials are required then this setback could be a two year delay."