The Food and Drug Administration cited “deficiencies” in Ascendis’ hypoparathyroidism drug application, potentially halting momentum for its expected approval by April. Ascendis president and CEO Jan Mikkelsen said the FDA notice could delay the agency’s approval deadline. (Endpoints News)
The Federal Trade Commission ordered Illumina to divest cancer detection test maker Grail. Judge Michael Chappell, an administrative law judge at the agency, ruled last year that the $7.1 billion acquisition would not hurt competition. The FTC staff had appealed the decision to agency leadership. (Reuters)
Life science labs and R&D sites in the U.S. grew by 50% in the last five years, according to a recent report. Life science properties may take up some 220 million square feet by 2025 as various new sites are completed. (Axios)
The Biden administration appealed a decision by a federal judge in Texas that would halt free coverage of preventive health services in the Affordable Care Act. The case, which puts certain free cancer screenings and HIV prevention care in jeopardy, is now going to the U.S. Fifth Circuit Court of Appeals. (CNBC)
Vertex Pharmaceuticals and CRISPR Therapeutics submitted the first CRISPR therapy for sickle cell disease to the FDA, beating rival Bluebird Bio in the process. If approved, Vertex and CRISPR Therapeutics’ drug, exa-cel, would become the first CRISPR therapy for the disease to hit the market. (STAT News)
