Industry News

FDA – GDUFA Accomplishments

As the Generic Drug User Fee Amendments of 2012 (GDUFA) approaches the first anniversary of its enactment, the program has achieved a number of significant milestones. The program, designed to speed access to safe and effective generic drugs by supplementing federal funds with industry user fees, has: Made significant strides in reducing the backlog of … Continued

Industry News

Remicade knockoff delivers pioneering antibody biosimilar OK for Hospira, Celltrion

The antibody knockoffs are coming–gradually. Today the European Commission made healthcare history with its first approval of a biosimilar antibody–Inflectra (infliximab)–which was developed by Korea’s Celltrion and will be sold by generics powerhouse Hospira ($HSP). But the companies don’t expect to file for U.S. approval until 2015 as they wait for the FDA to finalize … Continued

Industry News

Biosimilar bill passed by California Assembly

The biosimilar market is a rapidly-growing segment of the pharmaceutical industry, but the US is still in the early stages of developing biosimilar regulation. In recent months, several US states have been contemplating passing bills on biosimilar drug use, and the California Assembly is thelatest to pass such a bill. The Californian legislation would require … Continued

Industry News

Statement On U.S. Supreme Court Review Of Isolated DNA Patents

Washington, D.C. (June 13, 2013) Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), today issued the following statement on the U.S. Supreme Court’s decision regarding Myriad Genetics’ patent claims on isolated DNA molecules: “The Supreme Court today summarily ruled that so-called cDNA remains eligible for patenting. cDNA is the commercially most important … Continued

GeneriCo News

GeneriCo, LLC announced today the formation of the company and launched its website at www.genericopharma.com

St. Louis, MO – June 1, 2013 GeneriCo is a technology driven pharmaceutical company dedicated to the development of specialty generic drugs. The company is founded by industry veterans with over 100 years of combined experience in the development, manufacturing, and sales/marketing of both branded and generic pharmaceutical products. The founding team has serial successes … Continued

GeneriCo News

GeneriCo $2.5 million funding round

Original posting date – May 22, 2013 – St. Louis, MO St. Louis-based GeneriCo LLC is in the middle of a $2.5 million fundraising round, according to a recent filing with the U.S. Securities and Exchange Commission (SEC). Generico develops and markets generic pharmaceuticals. It focuses on generics that have been neglected by mid and … Continued