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 ($IPXL) is on a roll. The Hayward, CA-based developer announced Monday evening that the Parkinson's drug it in-licensed from GlaxoSmithKline last year--its second attempt at an
This morning, MarketWatch's Michael Shulman listed some of what he sees are the hottest bargain biotech stocks for this year: Cerus, Curis, Compugen, Spectrum Pharmaceuticals and Impax Laboratories.
With investigators at Impax Pharmaceuticals ($IPXL) preparing to reap a final round of late-stage data for their Parkinson's drug IPX066, GlaxoSmithKline ($GSK) has stepped up to license marketing