Tag:

Impax Labs

Latest Headlines

Latest Headlines

Impax gives it another go with a once-rejected Parkinson's drug

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.

Impax to get new CEO as it tries to right manufacturing issues

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.

Impax cuts 110 jobs tied to problems at plant

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.

GlaxoSmithKline throws in the towel on $186M Parkinson's pact with Impax

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 handed 12-page 483 at reevaluation

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.

FDA stiff-arms Impax on extended-release Parkinson's combo

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: Second PhIII Parkinson's drug study turns in winning data

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

Impax reveals warning letter related to drug recall

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 Labs' Parkinson's drug aces late-stage clinical trial

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

Shulman: Best biotech stocks to own

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.