We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized last week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
Indian generics maker Dr. Reddy’s Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. Read More
The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More
Indian generics makers have hired a U.S.-based lobbyist to head off the threat of a trade downgrade and polish an image that has been tarnished by FDA import bans and warning letters for manufacturing practice violations. Read More
Alabama’s Supreme Court Aug. 15 reaffirmed its ruling that a brand drugmaker can be held liable for damages caused by a generic version of its product if the generic carries warning labels that are drafted by the brand company. Read More
1.7 million treatments will be sent to Burkina Faso, the Democratic Republic of Congo, Burundi, Nigeria, Liberia and Niger in the coming months. Read More
Actavis has launched a generic challenge against UCB’s Parkinson’s disease drug Neupro, and is facing a patent infringement lawsuit as a result. Read More
Argentina recently agreed to open its borders to finished drug products from India, a policy change applauded by Indian manufacturers who now have access to the multi-billion-dollar market. Read More
Generic versions of Ferring Pharmaceutical’s menstrual bleeding drug Lysteda can move forward after the brandmaker lost a pair of appeals in patent infringement lawsuits seeking to block ANDAs against the product. Read More
Drugmaker ViiV Healthcare is set to launch its triple combination HIV therapy Triumeq in the U.S., after receiving a green light from the FDA. Read More
Swiss pharmaceutical company Roche said yesterday it will acquire California-based biotechnology firm InterMune for $8.3 billion, in a deal that allows Roche to strengthen its respiratory therapy portfolio. Read More