Amgen Inc. made history on Oct. 27 by gaining the FDA's approval for the first oncolytic virus therapy – Imlygic (talimogene laherparepvec), which is indicated as a local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.
Amgen Inc. made history on Oct. 27 by gaining the FDA's approval for the first oncolytic virus therapy – Imlygic (talimogene laherparepvec), which is indicated as a local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.
Shares of Amgen got a 1.5% boost, or a gain of $2.52, in after-hours trading on Oct. 27.
In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.
The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.
PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.
Merck’s newly approved Enflonsia for RSV is one of the products that was expected to be recommended for use by the CDC advisory committee in June.
