Renal

Purespring has just raised $105m from an investor syndicate who are betting it can develop the first gene therapy for kidney disease and learn from setbacks experienced in the space.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Gazyva could add the autoimmune condition to its label following a Phase III hit, but it might struggle to differentiate itself from Benlysta and Lupkynis.    

Following the pivotal data on Alnylam’s Amvuttra, all eyes turn to the next amyloidosis readout – that of AstraZeneca and Ionis’ Wainua. And the UK major’s ambitions do not stop there.    

Vadadustat's review overlapped with two other oral HIF-PH class drugs. Safety issues with FibroGen/AstraZeneca’s roxadustat drew attention during vadadustat's first-cycle review, while GSK’s Jesduvroq labeling and postmarketing requirements informed the second-cycle approval.

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.

Following the pivotal data on Alnylam’s Amvuttra, all eyes turn to the next amyloidosis readout – that of AstraZeneca and Ionis’ Wainua. And the UK major’s ambitions do not stop there.    

During a tour of Truvian’s San Diego headquarters, Medtech Insight spoke with the company’s top executives about their unique three-in-one blood-testing benchtop system, plans for FDA regulatory filing, and marketing strategy.

The big pharma’s second selection in the alliance shows novel cardiovascular therapies are high on its priority list