Diamyd Medical earns back rights to diabetes drug from J&J subsidiary
STOCKHOLM — Swedish drug maker Diamyd Medical has regained control of its investigational drug for Type 1 diabetes following Johnson & Johnson’s termination of a development deal between the two companies.
Diamyd and J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals signed the deal to develop the drug, also known as Diamyd, in June 2010. But last month, Diamyd Medical reported that a phase-3 trial of the drug in Europe showed that it failed to achieve the goal of improving beta cell function in newly diagnosed Type 1 diabetes patients, leading to the cancellation of a follow-up study.
Under the deal, following J&J’s termination of the agreement, all rights for Diamyd returned to Diamyd Medical.
“We have thoroughly enjoyed working with Ortho-McNeil-Janssen Pharmaceuticals and we hope to have more opportunities for cooperation in the future,” Diamyd acting president and CEO Peter Zerhouni said.
New flu vaccine will mirror this past season’s
WASHINGTON — The Centers for Disease Control and Prevention said that the Food and Drug Administration has recommended that the flu vaccine for the 2011-2012 season protect against the same strains as it did this year.
The FDA’s Vaccines and Related Biological Products Advisory Committee recommended that the vaccine will protect those immunized against H1N1, H3N2 and a type of influenza-B virus, the same formulation as this past season’s vaccine.
This past 2010-2011 flu season, outpatient visits for influenza-like illness peaked at 4.6% during the week ended Feb. 19, according to the CDC. What’s more, based on the percentage of deaths resulting from pneumonia or flu, the number of flu-associated pediatric deaths reported and the percentage of visits to outpatient clinics for ILI, the CDC reported that the 2010-2011 flu season was less severe than the 2009-2010 and 2007-2008 seasons, but more severe than the 2008-2009 flu season.
Impax confirms patent challenge for generic Detrol
HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.
Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.
Impax filed a regulatory approval application with the Food and Drug Administration for the drug that contained a Paragraph IV certification, a legal assertion that patents covering Detrol are invalid, unenforceable or won’t be infringed.
Detrol had sales of about $62 million during the 12-month period ended in March, according to Wolters Kluwer Health.