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.
U.S. regulators have delayed the potential launch of a once-monthly version of the blockbuster antipsychotic Abilify. Otsuka Pharmaceutical and partner H. Lundbeck broke the bad news today that the FDA handed the companies a complete response letter (CRL), saying deficiencies were uncovered in an inspection of a third-party supplier of sterile water for making the drug.
In the aftermath of a failed Phase III trial for Elan's Alzheimer's drug, the Irish pharma group appears better suited as a takeover target for biotech powerhouse Biogen Idec, analysts from Jefferies Group and RBC argue.
Nathan Sadeghi-Nejad writes that the company needs to build on its success in drug delivery, perhaps through timely acquisitions of smaller firms.
In anticipation of the U.S. approval of Bydureon, San Diego's Amylin Pharmaceuticals ( $AMLN ) was already amping up production of the diabetes drug at its West Chester Township, OH, plant where...