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RSS FeedPosted by Michael Wonder on 19 Jul 2024
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the relief of heartburn associated with non-erosive GERD in adults
18 July 2024 - Voquenza met its primary endpoint in its Phase 3 pivotal trial by demonstrating a significant and rapid ...
Posted by Michael Wonder on 19 Jul 2024
Lexicon Pharmaceuticals receives 20 December 2024 PDUFA goal date for sotagliflozin type 1 diabetes NDA resubmission
16 July 2024 - Launch preparations actively underway; launch planned for early 2025. ...
Posted by Michael Wonder on 19 Jul 2024
Johnson & Johnson, BMS fight US drug price plan at Third Circuit
16 July 2024 - Pharmaceutical giants Johnson & Johnson, BMS and AstraZeneca are rejecting federal district court decisions that rule ...
Posted by Michael Wonder on 19 Jul 2024
Diamyd Medical receives second US FDA fast track designation for Diamyd - for the prevention of type 1 diabetes
18 July 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) to ...
Posted by Michael Wonder on 19 Jul 2024
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
17 July 2024 - PDUFA target action date of 15 January 2025. ...
Posted by Michael Wonder on 18 Jul 2024
Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-Surrogate and CONSORT-Surrogate extensions
11 July 2024 - Randomised trials are resource-intensive studies that provide robust evidence for evaluating the effectiveness of interventions. ...
Posted by Michael Wonder on 18 Jul 2024
Teclistamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments (review of previous guidance)
16 July 2024 - The Department of Health and Social Care has asked the NICE to review the guidance on ...
Posted by Michael Wonder on 18 Jul 2024
Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine
15 July 2024 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the company’s unique ...
Posted by Michael Wonder on 18 Jul 2024
Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute myeloid leukaemia
16 July 2024 - Opened enrollment for paediatric AML patients in on-going Phase 2 clinical trial. ...
Posted by Michael Wonder on 17 Jul 2024
ICER releases draft evidence report on treatments for transthyretin amyloid cardiomyopathy
17 July 2024 - Public comment period now open until 13 August 2024; requests to make oral comment during public ...
Posted by Michael Wonder on 17 Jul 2024
Longeveron announces US FDA grants fast track designation for Lomecel-B for the treatment of mild Alzheimer’s disease
17 July 2024 - Second designation received for Lomecel-B for the treatment of mild Alzheimer’s disease after regenerative medicine advanced therapeutics ...
Posted by Michael Wonder on 17 Jul 2024
The Biden-Harris Administration releases final Part Two guidance to help people with Medicare prescription drug coverage manage prescription drug costs
16 July 2024 - The Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), continues ...
Posted by Michael Wonder on 16 Jul 2024
ICER publishes final evidence report on treatment for chronic obstructive pulmonary disease
16 July 2024 - Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ...
Posted by Michael Wonder on 16 Jul 2024
Arrivo announces FDA fast track designation for RABI-767 for patients with acute pancreatitis predicted to progress to severe disease
15 July 2024 - RABI-767 is a novel lipase inhibitor currently in a Phase 2a clinical trial. ...
Posted by Michael Wonder on 16 Jul 2024
Sumitomo Pharma announces that DSP-5336 has received FDA fast track designation for the treatment of relapsed or refractory acute myeloid leukaemia
15 July 2024 - -- Sumitomo Pharma today announced that the US FDA granted fast track designation to DSP-5336 for ...