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RSS FeedPosted by Michael Wonder on 09 Jan 2018
pSivida submits new drug application for Durasert three year treatment for posterior segment uveitis to the U.S. FDA
8 January 2018 - Proven Durasert technology has to date received FDA approval for three of the four sustained release drug ...
Posted by Michael Wonder on 08 Jan 2018
Plans to slash medical costs in America run into generic drug concerns
6 January 2018 - FDA generics push comes amid quality enforcement woes in India. ...
Posted by Michael Wonder on 08 Jan 2018
HHS nominee Azar needs to come clean on Obamacare, Medicare in Senate hearings
8 January 2018 - Alex Azar, who has been nominated to replace Tom Price as Health and Human Services Secretary is ...
Posted by Michael Wonder on 08 Jan 2018
Ionis' inotersen NDA accepted for priority review by the FDA
8 January 2018 - Ionis Pharmaceuticals announced today that its new drug application for inotersen has been accepted for priority review ...
Posted by Michael Wonder on 08 Jan 2018
AbbVie's upadacitinib granted breakthrough therapy designation from the U.S. FDA for atopic dermatitis
8 January 2018 - Phase 3 clinical program for upadacitinib in atopic dermatitis, the most common type of eczema, is planned ...
Posted by Michael Wonder on 07 Jan 2018
Medical research? Congress cheers. Medical care? Congress brawls.
6 January 2018 - They cannot agree on subsidies for low-income people under the Affordable Care Act or even how ...
Posted by Michael Wonder on 07 Jan 2018
Humira’s best-selling drug formula: start at a high price. Go higher.
6 January 2018 - Humira is the best-selling prescription drug in the world. You may have seen the commercials. ...
Posted by Michael Wonder on 06 Jan 2018
FDA acceptance of NDA filing for Baremsis for the management of post-operative nausea & vomiting
4 January 2018 - If approved, Baremsis would be the first antiemetic with an indication for rescue treatment of post-operative ...
Posted by Michael Wonder on 06 Jan 2018
Mallinckrodt completes stannsoporfin new drug application filing
4 January 2018 - Mallinckrodt today announced it has successfully completed the rolling submission of a new drug application to ...
Posted by Michael Wonder on 06 Jan 2018
Patient-centered decision making: lessons from multi-criteria decision analysis for quantifying patient preferences
26 December 2018 - Patient preferences should be a central consideration in healthcare decision making. ...
Posted by Michael Wonder on 06 Jan 2018
Kala Pharmaceuticals announces new drug application for Inveltys (KPI-121 1%) has been accepted for review by the U.S. FDA
5 January 2018 - PDUFA target action date of 24 August 2018. ...
Posted by Michael Wonder on 06 Jan 2018
Association of immunotherapy with durable survival as defined by value frameworks for cancer care
28 December 2017 - Modern immuno-oncology agents have generated great excitement because of their potential to provide durable survival for some ...
Posted by Michael Wonder on 06 Jan 2018
FDA approves Xgeva (denosumab) for the prevention of skeletal-related events in patients with multiple myeloma
5 January 2018 - Approval based on safety and efficacy data from the largest international multiple myeloma clinical trial ever conducted. ...
Posted by Michael Wonder on 04 Jan 2018
Shire receives FDA breakthrough therapy designation for maribavir, an investigational treatment for cytomegalovirus infection in transplant patients
4 January 2018 - Shire today announced that the U.S. FDA) has granted breakthrough therapy designation for maribavir (SHP620), a Phase ...
Posted by Michael Wonder on 04 Jan 2018
Paratek provides update on pipeline progress
3 January 2018 - Rolling NDA submission underway for omadacycline in pneumonia and skin infections. ...