Blog
RSS FeedPosted 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
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 05 Jan 2018
Made in China: new and potentially lifesaving drugs
3 January 2018 - One new drug promises to stop cancer from spreading to other organs. Another would treat blood ...
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
VenatoRx Pharmaceuticals receives FDA’s QIDP and fast track designations for development of its lead antibiotic program
3 January 2018 - VenatoRx Pharmaceuticals, a private clinical-stage pharmaceutical company, announced today that the FDA has granted the company's ...
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. ...
Posted by Michael Wonder on 04 Jan 2018
Landmark schizophrenia data that bring hope in breaking the cycle of hospitalisation and incarceration receive FDA approval for inclusion in Invega Sustenna (paliperidone palmitate) label
3 January 2017 - Invega Sustenna is the first and only antipsychotic to demonstrate superior effectiveness in delaying time to ...
Posted by Michael Wonder on 04 Jan 2018
Novartis receives FDA breakthrough therapy designation for first-line use in severe aplastic anaemia
4 January 2018 - Regulatory filings of the first-line indication in US and EU expected in 2018. ...
Posted by Michael Wonder on 04 Jan 2018
VistaGen Therapeutics receives FDA fast track designation for AV-101 for the treatment of major depressive disorder
3 January 2018 - VistaGen Therapeutics announced today that the U.S. FDA has granted fast track designation to AV-101 for ...
Posted by Michael Wonder on 03 Jan 2018
Gene therapy for inherited blindness sets precedent: 850,000 dollar price tag
3 January 2018 - A landmark gene therapy to treat a rare, inherited form of blindness will cost $850,000 — ...
Posted by Michael Wonder on 03 Jan 2018
Statement from FDA Commissioner on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
3 January 2018 - The FDA today announced additional steps to encourage generic competition as part of our continued implementation of ...