Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2022
Digital Therapeutics should be regulated with gold standard evidence
28 February 2022 - There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive ...
Posted by Michael Wonder on 03 Mar 2022
AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease
1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...
Posted by Michael Wonder on 03 Mar 2022
Harpoon Therapeutics receives FDA fast track designation for HPN217
2 March 2022 - Harpoon Therapeutics today announced that the U.S. FDA has granted fast track designation to HPN217, a BCMA ...
Posted by Michael Wonder on 03 Mar 2022
Amneal enters U.S. biosimilars market with approval of Releuko (filgrastim-ayow)
1 March 2022 - First of three Amneal biosimilars expected for U.S. approval and launch in 2022. ...
Posted by Michael Wonder on 03 Mar 2022
FDA accepts Alvotech’s BLA supporting interchangeability for ATV02, a high concentration, citrate-free biosimilar candidate for Humira
28 February 2022 - Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and ...
Posted by Michael Wonder on 03 Mar 2022
FDA approves Kaléo’s naloxone auto-injector 10 mg for the treatment of known or potential exposure to ultra-potent weaponised opioids
2 March 2022 - Product received fast-track designation for military personnel facing the potential threat of exposure to synthetic opioids ...
Posted by Michael Wonder on 02 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women
2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...
Posted by Michael Wonder on 02 Mar 2022
Advanced Innovative Partners announces designation for rare paediatric disease drug
1 March 2022 - AIP is pleased to announce that the U.S Food and Drug Administration (FDA) has granted Orphan Drug ...
Posted by Michael Wonder on 02 Mar 2022
Progression-free survival: it is time for a new name
1 March 2022 - Progression-free survival refers to the time from randomisation or initiation of treatment to the occurrence of disease ...
Posted by Michael Wonder on 02 Mar 2022
Assessing unexpected circumstances that lead to modifications in clinical trial design, conduct, or analysis application of the CONSERVE Reporting Guideline
1 March 2022 - In the COVID-19 Dexamethasone (CoDEX) randomised clinical trial, which studied a sample of critically ill patients with ...
Posted by Michael Wonder on 02 Mar 2022
Cormedix announces resubmission of new drug application for Defencath
28 February 2022 - CorMedix today announced that it has resubmitted the new drug application for DefenCath to address the ...
Posted by Michael Wonder on 02 Mar 2022
DynamiCare Health digital therapeutic receives FDA breakthrough device designation for treatment of smoking during pregnancy
23 February 2022 - If approved, DynamiCare’s DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe ...
Posted by Michael Wonder on 01 Mar 2022
Gilead receives complete response letter from U.S. FDA for investigational lenacapavir due to vial compatability issues
1 March 2022 - Complete response letter cites issues related to compatibility of vials and lenacapavir solution. ...
Posted by Michael Wonder on 01 Mar 2022
Carvykti (ciltacabtagene autoleucel), BCMA directed CAR-T therapy, receives U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma
28 February 2022 - Approval is primarily based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 01 Mar 2022
CTI BioPharma announces FDA accelerated approval of Vonjo (pacritinib) for the treatment of adult patients with myelofibrosis and thrombocytopenia
28 February 2022 - New drug application approved under priority review. ...