Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
During Q1FY26, the company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D
Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date
Phosphate-based excipients provide higher bulk densities and enable the reduction of the tablet sizes
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
Enables additional US manufacturing capacity to serve increased demand for pharma/biotech customers
The transaction, approved by both companies' boards of directors, is expected to close by the end of the first quarter of 2026
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
The global TCIM market is expected to reach nearly US$ 600 billion by 2025
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