Regulation & Policy

Algeta cancer treatment approved by FDA

A new radiopharmaceutical developed by Algeta ASA of Norway to treat men with prostate cancer that has spread to the bones has been approved by the US Food and Drug Administration. The product (radium-223) is an alpha-emitting nuclide.

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Location

United States

European Medicines Agency to reorganise

The European Medicines Agency has announced plans to change its structure from August in order to respond to public demands for more pharmaceutical data and to give stronger support to industry in the research and development of new drugs.

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Location

United Kingdom

European court puts stay on EMA disclosure

The European Medicines Agency has been ordered not to release documents relating to marketing authorisation applications from AbbVie Inc and InterMune Inc pending a final judgement. This follows a legal challenge by the two US companies to the agency’s transparency policy.

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Location

United Kingdom

FDA approves new pooled plasma

The US Food and Drug Administration has approved a new drug from CSL Behring in Germany to reverse anticoagulation in adults with acute major bleeding. To date, plasma has been the only other approved treatment in the US for this condition.

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Location

United States

EMA recommends new ATMP product

The European Medicines Agency is recommending approval of a new advanced therapy medicinal product which is intended for the repair of cartilage defects. The product had been available in some EU countries, but now it will be widely traded.

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Location

United Kingdom

SME applications to EMA on the rise

The workload of the European Medicines Agency increased in many areas during 2012 but notable was an increase in services to small and medium-sized enterprises (SME’s).

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Location

United Kingdom

EMA investigates diabetes drugs

The European Medicines Agency has announced an investigation into academic findings that suggest an increased risk of pancreatitis and pancreatic duct metaplasia in patients with Type 2 diabetes who take GLP-1 agonists and DPP-4 inhibitors.

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Location

United Kingdom

Complete response letter for GSK vaccine

GlaxoSmithKline Plc has had its application for a new influenza treatment turned back by the US Food and Drug Administration owing to an administrative matter. Announcing receipt of a ‘complete response letter,’ GSK said the matter has recently been resolved.

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Location

United Kingdom

Trajenta won’t be launched in Germany - BI

The Type-2 diabetes drug Trajenta (linagliptin) won’t be launched in Germany following a decision by the county’s reimbursement authority that it doesn’t provide any additional benefit compared with medicines already on the market.

Location

Germany

FDA approves T-DM1 for breast cancer

The US Food and Drug Administration has approved the Roche group’s antibody-drug conjugate, trastuzumab emtansine, for HER2-positive metastatic breast cancer, ushering in a new drug class linking an antibody with a cytotoxic drug.

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Location

United States

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