After a manufacturing problem irked the FDA and scared off partner GlaxoSmithKline, Impax Laboratories is resubmitting its investigational drug for Parkinson's disease, hoping it can clear an agency inspection and finally get its treatment on the market.
A team of outside experts has been taking steps to help Impax Laboratories get back on track after manufacturing issues sidetracked a key drug application and a key partnership with GlaxoSmithKline.
Manufacturing problems at Impax Laboratories' California plant first cost the company a drug approval, then a $186 million partnership with GlaxoSmithKline. Now, it is costing 110 workers their jobs.
A little more than two years after signing up GlaxoSmithKline as its Big Pharma partner on an extended-release version of a carbidopa-levodopa combo for Parkinson's disease, Impax Laboratories is headed back to the bargaining table. The FDA rejected the drug based on manufacturing issues a few months ago, and a frustrated Glaxo has now decided to drop out of the game.
Impax Laboratories' struggles to get its manufacturing practices down at a plant in California where it intends to produce Rytary, an extended-release Parkinson drug, persist, the company has confessed. In fact, after reinspection of the plant, Impax received a Form 483 with a dozen observations, three of them repeats.
The FDA has thrown up a roadblock for Impax Laboratories' ($IPXL) extended-release version of a carbidopa-levodopa combo for Parkinson's disease now dubbed Rytary.
GlaxoSmithKline says that the second of three planned Phase III studies for a reformulated Parkinson's treatment partnered with Impax Laboratories turned in positive numbers, with patients in the
Inadequate sampling and testing has garnered Impax Labs a warning letter from the FDA for manufacturing violations. The Hayward, CA, drugmaker announced yesterday--prior to its posting on the FDA
Impax Laboratories ($IPXL) is on a roll. The Hayward, CA-based developer announced Monday evening that the Parkinson's drug it in-licensed from GlaxoSmithKline last year--its second attempt at an
This morning, MarketWatch's Michael Shulman listed some of what he sees are the hottest bargain biotech stocks for this year: Cerus, Curis, Compugen, Spectrum Pharmaceuticals and Impax Laboratories.