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RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Apr 2019
Abeona Therapeutics receives FDA fast track designation for ABO-101 for treatment of Sanfilippo syndrome type B
4 April 2019 - Ongoing Phase 1/2 study of ABO-101 enrolling eligible patients with MPS IIIB. ...
Posted by Michael Wonder on 04 Apr 2019
The importance of predefined rules and pre-specified statistical analyses: do not abandon significance
4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance. ...
Posted by Michael Wonder on 04 Apr 2019
FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...
Posted by Michael Wonder on 04 Apr 2019
Daiichi Sankyo provides update on ongoing FDA review for quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
4 April 2019 - Daiichi Sankyo today announced that the U.S. FDA has extended the review period for the new ...
Posted by Michael Wonder on 04 Apr 2019
FDA expands approved use of metastatic breast cancer treatment to include male patients
4 April 2019 - The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination ...