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.
Alkermes spinout Civitas Therapeutics today reported positive topline results from a Phase II clinical trial of its Parkinson's drug CVT-301, which uses a respiratory delivery system to provide quick relief to patients experiencing motor fluctuations common to long-term treatment of the disease.
Alkermes has a shot at offering a new option for treating depression in patients who don't respond to existing drugs. The company revealed positive preliminary data from a Phase II study of ALKS 5461, an opioid-receptor targeting drug, which the biotech player now aims to march into pivotal development.
Analysts at GlobalData took a quarterly snapshot of the R&D expenses for a big batch of mid-cap biotechs and concluded that rising research costs were eroding corporate profitability. And they pinned the blame squarely on the pricey hunt for new cancer drugs.
In the biotech arena, some people have become well-known by their Twitter handles that include the "@" symbol and some combination of numbers, letters and characters.
Lundbeck and its partner Otsuka have put their bid for an approval of their long-acting version of the antipsychotic drug Abilify back on the regulatory track. The partners on aripiprazole say that the FDA has accepted their resubmission for the treatment and set a PDUFA deadline for the end of February in 2013.