The clinical trial failure of Theravance Biopharma’s most advanced internal program, a drug for a rare blood pressure disorder, is leading to a companywide restructuring. Going forward, the biotech will focus on developing drugs for respiratory disorders.
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.
Mallinckrodt Pharmaceuticals received FDA approval for its engineered skin product, StrataGraft, a treatment for serious thermal burns. The product is the latest to be reviewed under a new designation for regenerative medicines.
The at-home testing startup plans to launch a broader virtual care offering after raising $150 million in funding. It plans to roll out virtual visits and offer prescription medications, in addition to building out its array of tests.
Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage.
Medtronic suffered a shocking setback back in 2014 when its Symplicity 3 pivotal trial failed to meet its primary endpoint of reducing blood pressure meaningfully. Now it is gearing up to present new data to the FDA.