Latest from Jessica Merrill
FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.
Drug manufacturers may find comfort in the appointment of former biotech CEO and entrepreneur George Tidmarsh to lead the FDA’s Center for Drug Evaluation and Research.
After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.
Stelara revenues declined 42.7% in the quarter due to biosimilars, but innovative medicines grew 4.9%, surpassing $15bn for the quarter. Although pharma tariffs could be coming, the firm said the impact continues to be hard to predict.
CEO Rob Davis said the company is in pursuit of more deals as it looks to close the revenue gap looming from the loss of Keytruda in 2028.
With the $10bn acquisition of Verona, Merck gains the marketed COPD drug Ohtuvayre, reentering respiratory, where it was once a leader with Singulair.