Blog
RSS FeedPosted by Michael Wonder on 09 Jan 2018
Eisai and Merck receive breakthrough therapy designation from U.S. FDA for Lenvima (lenvatinib mesylate) and Keytruda (pembrolizumab) as combination therapy for advanced and/or metastatic renal cell carcinoma
9 January 2018 - Eisai and Merck announced today that they received breakthrough therapy designation from the U.S. FDA for Eisai’s ...
Posted by Michael Wonder on 09 Jan 2018
GBT receives FDA breakthrough therapy designation for voxelotor for treatment of sickle cell disease
9 January 2018 - Voxelotor is first investigational treatment for sickle cell disease to receive breakthrough therapy designation. ...
Posted by Michael Wonder on 09 Jan 2018
How Allergan continues to make drug prices insane
9 January 2018 - The company kept a promise to limit increases to the single digits. But it didn't stop abusing ...
Posted by Michael Wonder on 09 Jan 2018
Trump health pick wary of government drug price negotiations
9 January 2018 - Empowering Medicare to negotiate drug prices could leave patients with reduced access to medications, President Donald ...
Posted by Michael Wonder on 09 Jan 2018
Reflections on a landmark year for medical product innovation and public health advances and looking ahead to policy in 2018
9 January 2018 - As we look ahead to 2018, I’d like to take a moment to reflect on an ...
Posted by Michael Wonder on 09 Jan 2018
FY 2017 Report from the Director
8 January 2018 - The Center for Biologics Evaluation and Research worked diligently during Fiscal Year 2017 to fulfil its ...
Posted 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 ...