Blog
RSS FeedPosted by Michael Wonder on 12 Apr 2019
FDA approves expanded monotherapy label for Merck’s Keytruda (pembrolizumab)
11 April 2019 - Keytruda now approved for first-line treatment of patients with Stage III NSCLC who are not candidates for ...
Posted by Michael Wonder on 11 Apr 2019
On rising insulin prices, law maker tells pharma execs: 'Your days are numbered'
10 April 2019 - Lawmakers tensed with frustration, some clenching their jaws, while grilling a panel of pharmacy and pharmaceutical ...
Posted by Michael Wonder on 11 Apr 2019
Cosmo Pharmaceuticals announces submission of remimazolam NDA TO FDA
9 April 2019 - Cosmo Pharmaceuticals today informed that the Remimazolam NDA has been submitted to FDA. ...
Posted by Michael Wonder on 10 Apr 2019
FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...
Posted by Michael Wonder on 10 Apr 2019
The evolving uses of “real world” data
9 April 2019 - The terms real world data and real-world evidence have entered the medical lexicon to refer to ...
Posted by Michael Wonder on 09 Apr 2019
FDA approves new treatment for osteoporosis in post-menopausal women at high risk of fracture
9 April 2019 - The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women ...
Posted by Michael Wonder on 09 Apr 2019
Biosimilars are a distraction
8 April 2019 - Biopharmaceutical products (also known as biologics) are among the most expensive pharmaceutical products on the market, and ...
Posted by Michael Wonder on 09 Apr 2019
PhaseBio receives FDA breakthrough therapy designation for PB2452 for the reversal of the anti-platelet activity of ticagrelor
8 April 2019 - In Phase 1 clinical trial, PB2452 provided immediate and sustained reversal of ticagrelor anti-platelet effects. ...
Posted by Michael Wonder on 09 Apr 2019
uniQure receives FDA fast track designation for AMT-130 gene therapy for the treatment of Huntington’s disease
8 April 2019 - On track to treat first patient in Phase I/II study of AMT-130 in 2H19. ...
Posted by Michael Wonder on 08 Apr 2019
Pazdur on pandemonium: calls for collaboration, competition on PD-1 drugs
8 April 2019 - Pazdur chastises PD-1/PD-L1 pharmas for losing sight of patients. ...
Posted by Michael Wonder on 08 Apr 2019
Zogenix receives refusal to file letter from U.S. FDA for Fintepla new drug application
8 April 2019 - Zogenix today announced that it received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 08 Apr 2019
FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
8 April 2019 - The U.S. FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of ...
Posted by Michael Wonder on 07 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept biologics license application to U.S. FDA
5 April 2019 - Submission includes both myelodysplastic syndromes and beta-thalassemia indications. ...
Posted by Michael Wonder on 07 Apr 2019
Gilead submits supplemental new drug application to U.S. FDA for once daily Descovy for HIV pre-exposure prophylaxis
5 April 2019 - Filing supported by data demonstrating non-inferiority compared to Truvada coupled with bone and renal safety advantages in ...
Posted by Michael Wonder on 07 Apr 2019
Kyowa Kirin announces FDA acceptance of istradefylline (KW-6002) new drug application resubmission in the US
4 April 2019 - Kyowa Hakko Kirin announced that the U.S. FDA has accepted for review the resubmitted new drug ...