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RSS FeedPosted by Michael Wonder on 29 Oct 2019
FDA issues new recommendations to combat drug shortages, but can it really fix the problem?
29 October 2019 - The growing number of drug shortages plaguing the U.S. health care system is due to what ...
Posted by Michael Wonder on 29 Oct 2019
Statement on FDA’s new report regarding root causes and potential solutions to drug shortages
29 October 2019 - One of the U.S. FDA’s top priorities is to ensure that Americans have access to safe ...
Posted by Michael Wonder on 29 Oct 2019
Omeros Corporation initiates BLA submission for narsoplimab for the treatment of HSCT-TMA
28 October 2019 - Rolling submission of the remaining BLA sections continues on track for scheduled completion 1H 2020. ...
Posted by Michael Wonder on 29 Oct 2019
Blueprint Medicines announces FDA intent to split avapritinib new drug application into separate submissions for PDGFRA exon 18 mutant GIST and fourth-line GIST
28 October 2019 - Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA ...
Posted by Michael Wonder on 28 Oct 2019
Mirum Pharmaceuticals announces breakthrough therapy designation for maralixibat for the treatment of pruritus associated with Alagille syndrome
28 October 2019 - Mirum Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for maralixibat for the ...
Posted by Michael Wonder on 28 Oct 2019
CARsgen announces investigational CAR-T therapy CT053 granted RMAT designation by the U.S. FDA for relapsed/refractory multiple myeloma
28 October 2019 - CARsgen Therapeutics today announced that the United States FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 28 Oct 2019
U.S. FDA grants fast track designation to Astellas for the development of ASP1128 for patients at risk for acute kidney injury
28 October 2019 - Astellas Pharma today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
Posted by Michael Wonder on 28 Oct 2019
FDA approves Medicines360’s Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to six years, the longest approved duration of use of any hormonal IUDs
28 October 2019 - Medicines360 announced that the U.S. FDA approved Medicines360’s Supplemental new drug application to extend the duration of ...
Posted by Michael Wonder on 28 Oct 2019
Heron Therapeutics announces FDA acceptance of new drug application resubmission for HTX-011 for management of post-operative pain
28 October 2019 - FDA sets prescription drug user fee act goal date of 26 March 2020. ...
Posted by Michael Wonder on 28 Oct 2019
European Commission approves Bavencio (avelumab) plus axitinib combination for first-line treatment of patients with advanced renal cell carcinoma
28 October 2019 - EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with Bavencio ...
Posted by Michael Wonder on 28 Oct 2019
Where next for randomised controlled trials in global health?
26 October 2019 - The 2019 Nobel Memorial Prize in Economic Sciences was awarded to three economists—Esther Duflo, Abhijit Bannerjee, and ...
Posted by Michael Wonder on 27 Oct 2019
Making life-saving medical treatments more affordable
25 October 2019 - Recent years have brought significant innovation in potentially curative therapies for several diseases. To expedite patient ...
Posted by Michael Wonder on 27 Oct 2019
Spectrum Pharmaceuticals announces submission to the U.S. FDA of updated biologics license application for Rolontis
24 October 2019 - Rolontis filing is based on two large pivotal randomised controlled studies that met all primary and secondary ...
Posted by Michael Wonder on 26 Oct 2019
Public sector financial support for late stage discovery of new drugs in the United States: cohort study
23 October 2019 - This study determined the extent to which late stage development of new drugs relies on support from ...
Posted by Michael Wonder on 26 Oct 2019
Melinta Therapeutics announces U.S. FDA approval of supplemental new drug application for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia
25 October 2019 - Approval based on positive phase III trial results of Baxdela for treatment of CABP in Adults. ...