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March 4, 2013
08:06 EDTITMNInterMune reaches agreement with AIFA on Esbriet
On March 1, InterMune reported that it had concluded pricing and reimbursement discussions with the Pricing and Reimbursement Commission of the Italian Medicines Agency, or AIFA, the national authority responsible for drug regulation in Italy. Specifically, InterMune and the CPR of the AIFA have reached an agreement regarding the pricing and reimbursement conditions of Esbriet for the treatment of adult patients with mild to moderate idiopathic pulmonary fibrosis. The terms and conditions of the agreement on pricing and reimbursement are consistent with InterMuneís expectations. At the initiation of treatment with Esbriet therapy, patients with mild to moderate IPF will be recorded in a registry maintained by the AIFA. Registries are common in Italy for specialty medicines. Reimbursement for Esbriet will be subject to a risk sharing agreement, an approach which is common in Italy for specialty and cancer medicines. These agreements typically involve refunding of the cost of a patientís medicine if certain performance metrics of that patient are not met over a predefined period of time. InterMune projects that the costs of Esbriet therapy for approximately 10% of new patients may be subject to refund in the form of a credit note as a result of the risk sharing agreement.
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July 21, 2014
11:19 EDTITMNInterMune July weekly volatility elevated
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July 17, 2014
12:42 EDTITMNInterMune receives FDA Breakthrough Therapy Designation for pirfenidone
InterMune announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. FDA. This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Pirfenidone is an investigational treatment for adult patients with idiopathic pulmonary fibrosis.

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