Following an initial rejection in 2023, Ascendis Pharma on Tuesday said it faces another regulatory bump in the road for TransCon PTH with a three-month delay in the ongoing FDA review.
After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients.
Neuralink’s disclosure last week that tiny wires inside the brain of its first patient had pulled out of position is an issue the Elon Musk company has known about for years, according to five people familiar with the matter.
Collecting patient data through electronic PROs (ePROs) or electronic clinical outcome assessments (eCOAs) has been integral for patient centricity. These tools allow sponsors to meet patients where they are to gather real-time insights directly from the source, boosting patient retention and engagement. ePROs and eCOAs improve clinical trial outcomes with additional data points around a patient’s experience. However, the addition of consumer technologies that can collect ambient data points is poised to enhance outcomes even more, bringing treatments faster to those who need them most.
Mergers and acquisitions (M&As) in the biopharmaceutical industry have rebounded with a $76.9 billion increase in total deal value seen from 2022 to 2023. In Q1 2024 alone, biopharmaceutical M&A reached a total deal value of $43.5 billion, with a 71% year-on-year (YoY) increase of mega deals that were valued at $1 billion or more compared to Q1 2023, reveals GlobalData.
In today’s first-quarter 2024 financial results, Bayer reported a slight drop in sales amid its sweeping companywide restructuring that resulted in workforce reductions, while lowering its full-year earnings outlook.