Replidyne faropenem NDA in 2005
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Replidyne will file an NDA for its oral antibiotic faropenem "later this year," the firm announces at the Biotechnology Industry Organization's investor conference Feb. 24. Replidyne is touting faropenem as having a broad spectrum of activity comparable to the quinolones with a safety profile similar to the beta-lactam class. The company believes the antibiotic market size will allow the drug to generate significant sales with a relatively small share. Bayer in-licensed faropenem from Daiichi Suntory but dropped it in 2002; Replidyne acquired rights in August 2004 (1Pharmaceutical Approvals Monthly September 2004, p. 16)...
You may also be interested in...
Japanese Pharma Sea Change: U.S. Development Takes Focus Over Licensing
Japanese pharma firms are changing the long-standing practice of out-licensing products in the U.S., with maturing U.S. operations now directly developing more than a dozen drugs in or near Phase III.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.