Blog
RSS FeedPosted by Michael Wonder on 18 Mar 2020
DBV Technologies provides update on Viaskin Peanut BLA for children ages 4-11 years
16 March 2020 - DBV Technologies today announced that the U.S. FDA has informed the Company that during its ongoing review ...
Posted by Michael Wonder on 18 Mar 2020
Medicines Australia welcomes Government’s COVID-19 package
18 March 2020 - Medicines Australia welcomes the $2.4 billion COVID-19 health package announced by the Prime Minister Scott Morrison ...
Posted by Michael Wonder on 17 Mar 2020
Mallinckrodt completes rolling submission of new drug application to the U.S. FDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1
17 March 2020 - Terlipressin would be the first FDA approved treatment option in the United States for adult patients with ...
Posted by Michael Wonder on 17 Mar 2020
Explaining health state utility assessment
17 March 2020 - Health state utilities are used to provide quantitative measures of how strongly a person values a certain ...
Posted by Michael Wonder on 17 Mar 2020
Mass shipment of testing kits arrives as government pleads for supplies
17 March 2020 - The first shipment among 100,000 new coronavirus testing kits were due to arrive in Australia on ...
Posted by Michael Wonder on 17 Mar 2020
Generic ‘identity’ gets lost when companies juggle both generic and brand drugs
17 March 2020 - We think we know generic drug companies. They challenge patents held by brand firms. They litigate ...
Posted by Michael Wonder on 17 Mar 2020
FDA provides more regulatory relief during outbreak, continues to help expedite availability of diagnostics
16 March 2020 - Today, as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated ...
Posted by Michael Wonder on 17 Mar 2020
Making a new vaccine is not a race, it is a lottery
17 March 2020 - The COVID-19 novel coronavirus outbreak has challenged global researchers to find a vaccine. ...
Posted by Michael Wonder on 17 Mar 2020
Teva and Celltrion Healthcare announce U.S. availability of Herzuma (trastuzumab-pkrb) for injection
16 March 2020 - Teva Pharmaceuticals USA and Celltrion Healthcare today announced that Herzuma (trastuzumab-pkrb) for Injection, a biosimilar to Herceptin, ...
Posted by Michael Wonder on 16 Mar 2020
Aurinia Pharmaceuticals initiates rolling submission of a new drug application to the U.S. Food and Drug Administration for voclosporin in the treatment of lupus nephritis
16 March 2020 - Company remains on track to complete submission by the end of the second quarter 2020. ...
Posted by Michael Wonder on 16 Mar 2020
Paratek Pharmaceuticals announces the submission of the pre-emergency use authorisation application to the FDA for Nuzyra (omadacycline)
10 March 2020 - Purchase of the first 2,500 treatment courses of Nuzyra expected in the first half of 2020. ...
Posted by Michael Wonder on 16 Mar 2020
Shortcomings in the US pharmaceutical supply chain: potential risks associated with international manufacturing and trade-related tariffs
16 March 2020 - In 2016, an explosion at a factory of the Chinese industrial giant Qilu Pharmaceutical resulted in suspension ...
Posted by Michael Wonder on 16 Mar 2020
Chinese official warns against U.S. effort to limit foreign medicine supplies
17 March 2020 - A Chinese official on Monday warned that a push by the White House to reduce U.S. ...
Posted by Michael Wonder on 16 Mar 2020
Lilly receives FDA breakthrough therapy designation for baricitinib for the treatment of alopecia areata
16 March 2020 - Recognition reinforces baricitinib's potential to be the first FDA approved medicine for individuals living with alopecia areata. ...
Posted by Michael Wonder on 16 Mar 2020
2020 seasonal influenza vaccines
13 March 2020 - The Australian Influenza Vaccine Committee has reviewed data related to epidemiology, antigenic and genetic characteristics of ...