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RSS FeedPosted 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
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 15 Mar 2020
FDA finalises guidance for industry on applications for drugs with inadequate generic competition
13 March 2020 - Today, the U.S. FDA finalised guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that ...
Posted by Michael Wonder on 15 Mar 2020
For second time, FDA rejects Intarcia's diabetes implant
11 March 2020 - Boston-based Intarcia continues to run into a regulatory roadblock concerning its implanted diabetic pump ITCA 650. ...
Posted by Michael Wonder on 14 Mar 2020
Why test for proportional hazards?
13 March 2020 - The Cox proportional hazards model, introduced in 1972, has become the default approach for survival analysis in ...
Posted by Michael Wonder on 13 Mar 2020
Agenus receives fast track designation for balstilimab & zalifrelimab in advanced cervical cancer
12 March 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab ...
Posted by Michael Wonder on 12 Mar 2020
Coronavirus spurs U.S. efforts to end China’s chokehold on drugs
11 March 2020 - The Trump administration says the U.S. is too dependent on China for vital drugs. But it’s unclear ...