Alkermes has taken another step toward the market with its long-acting version of the schizophrenia drug Abilify, filing for an approval with the FDA as it lays the foundation for a hoped-for launch in 2015.
Alkermes has its sights set on Biogen Idec's blockbuster multiple sclerosis treatment, advancing a me-better candidate of its own into Phase I study.
Startup Alkeus is being sued by Irish drugmaker Alkermes for trademark infringement. According to the Boston Business Journal, the 25-year-old Alkermes filed the lawsuit on May 27, alleging that the smaller company's name could easily be mistaken for that of the more established developer of central nervous system disorder drugs.
Alkermes has crossed the finish line in a Phase III schizophrenia study of a long-acting version of Abilify, picking up the statistically significant results needed to back a new drug application later in the year.
J&J wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J as well as Alkermes, which provided their NanoCrystal delivery tech for the new-and-improved therapy.
Pharma naysayers have been known to accuse the industry of making drugs that cause side effects--and then making more drugs to treat those side effects. Now, a group of critics is taking aim at Zohydro, the new painkiller approved by FDA last month.
Ireland's Alkermes has hit a key milestone in its quest to develop a long-acting version of Abilify for schizophrenia. The biotech, which has R&D operations in Waltham, MA, says it has completed enrollment in the pivotal Phase III study, putting the research team on track to report top-line data in the first half of next year.
For some pharma dealmakers, corporate domiciles in Ireland have become hot commodities. The Irish tax code figured prominently in two recent biopharma buyout deals, and, as Bloomberg reports, this makes the biotech group Alkermes and Jazz Pharmaceuticals potential targets.
Alkermes built its reputation around drug delivery and formulation technology, contributing its know-how to develop new-and-improved therapeutics. Now it wants to use that knowledge to whip up a new slate of next-gen therapeutics that can outperform some blockbuster drugs on the market for chronic diseases.
Civitas Therapeutics heralded a successful Phase II trial result for its inhaled Parkinson's drug CVT-301, the novel delivery of which promises to make the disease more manageable for patients on an everyday basis, the company says.