Blog
RSS FeedPosted by Michael Wonder on 13 Jul 2018
FDA budget matters: investing in advanced domestic manufacturing
13 July 2018 - There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring ...
Posted by Michael Wonder on 13 Jul 2018
Amgen and UCB resubmit biologics license application for Evenity (romosozumab) to the US FDA
12 July 2018 - Application includes data from pivotal Phase 3 studies of more than 11,000 patients. ...
Posted by Michael Wonder on 13 Jul 2018
TGA calls on drug company to improve warnings over children's asthma drug after suicide
13 July 2018 - The TGA has called on manufacturers of the asthma medication Singulair to add warnings inside the ...
Posted by Michael Wonder on 13 Jul 2018
FDA approves the first drug with an indication for treatment of smallpox
13 July 2018 - The U.S. FDA today approved Tpoxx (tecovirimat), the first drug with an indication for treatment of smallpox. ...
Posted by Michael Wonder on 13 Jul 2018
PhRMA statement on efforts to support real world evidence
12 July 2018 - PhRMA spokesperson Andrew Powaleny issued the following statement on comments made by U.S. FDA Commissioner Scott Gottlieb. ...
Posted by Michael Wonder on 13 Jul 2018
Gilead receives approval in Canada for Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection
12 July 2018 - Gilead Sciences Canada today announced that Health Canada has granted a notice of compliance for Biktarvy (bictegravir ...
Posted by Michael Wonder on 13 Jul 2018
Health Canada approves Tagrisso (osimertinib) as first-line treatment for EGFR-mutated non-small cell lung cancer
12 July 2018 - Pivotal FLAURA study demonstrated 18.9 months median progression-free survival for patients receiving Tagrisso versus 10.2 months compared ...
Posted by Michael Wonder on 12 Jul 2018
Two boys, one horrific disease, different wonder drug funding
12 July 2018 - A young boy dying of a rare and horrifying genetic disease faces losing access to a ...
Posted by Michael Wonder on 12 Jul 2018
Statement by FDA Commissioner on the formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages
12 July 2018 - We’ve seen the number of new drug shortages steadily decline since a peak in 2011 owing to ...
Posted by Michael Wonder on 12 Jul 2018
Opdivo + Yervoy: first combination immunotherapy for advanced renal cell carcinoma (kidney cancer) receives TGA approval
11 July 2018 - Opdivo now approved in Australia for ten indications across six cancer types. ...
Posted by Michael Wonder on 12 Jul 2018
AbbVie announces submission of supplemental new drug application to US FDA for venetoclax in newly diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
12 July 2018 - The US FDA has granted venetoclax two breakthrough therapy designations in acute myeloid leukaemia, which are ...
Posted by Michael Wonder on 12 Jul 2018
Advaxis provides update on MAA filing
10 July 2018 - Advaxis today announced a clinical update. ...
Posted by Michael Wonder on 12 Jul 2018
Akcea and Ionis announce approval of Tegsedi (inotersen) in the European Union
11 July 2018 - Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, and Ionis Pharmaceuticals, announced today that Tegsedi (inotersen) has received ...
Posted by Michael Wonder on 11 Jul 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of patients with advanced hepatocellular carcinoma
11 July 2018 - Application based on monotherapy data from phase 2 KEYNOTE-224 trial. ...
Posted by Michael Wonder on 11 Jul 2018
FDA accepts biologics license application for subcutaneous formulation of Herceptin
11 July 2018 - Halozyme Therapeutics today announced that the US FDA has accepted a biologics license application from Genentech, a ...