The FDA has fueled a pharmaceutical arms race in the painkiller market with the agency's decision last month to bar the sale and production of generic OxyContin, which has become one of the most widely abused opioids among Americans.
Endo Health Solutions in 2010 forked over $1.2 billion for generic drugmaker Qualitest Pharmaceuticals as part of its strategy to prepare for patent losses, but manufacturing problems at Qualitest have been taking a financial toll on Endo and forced it to make investments into plants where the FDA has found issues.
Endo Health Solutions has been mired in investor malaise over the past year, stemming from a $2.9 billion acquisition of American Medical Systems that never paid off. Now shareholders are pleading for a sale, and analysts say device giant Covidien could be a perfect suitor.
Indian CRO GVK Biosciences has pulled in another pharma partner, teaming with Endo Pharmaceuticals to discover novel small molecules targeting pain and inflammation.
Mylan has gotten caught up in manufacturing problems at the generics operation of Endo Health Solutions, forcing it to recall three lots of generic Vicodin.
The drug companies say it's a safety issue. The generic competition, though, says it's about economics.
Raleigh, NC-based BioDelivery Sciences International has pieced together a $40 million raise from investors, providing the cash needed to wrap a critical late-stage pain therapy program on its way to a planned date with the FDA.
Based on positive results of a pharmacokinetic study, BioDelivery Sciences is planning a second-quarter 2013 submission for marketing approval of its BioErodible MucoAdhesive (BEMA) formulation of buprenorphine and naloxone for the treatment of opioid dependence.
The generics subsidiary of Endo Health Solutions is voluntarily recalling one lot of both hydrocodone bitartrate (generic Vicodin), and acetaminophen.
Allergan is looking to develop a needle-free formulation of Botox, and it has signed a co-development deal with American Medical Systems to use that company's JetTouch platform.