Friday, May 17, 11:23 AM
Impax Laboratories (IPXL -1.2%) says its Generic Division, Global Pharmaceuticals, has begun shipping its generic drug Zomig, which is used for the treatment of migraines in adults, as part of a licensing and distribution agreement with AstraZeneca (AZN).
Comment![Healthcare, Global & FX]
Monday, April 29, 10:30 AM
GlaxoSmithKline (GSK +0.1%) breaks off its relationship with Impax Laboratories (IPXL -1.1%) regarding the experimental Parkinson's drug Rytary due to "delays in the anticipated regulatory approval and launch dates in the countries in which GSK has rights to commercialize the product." GSK was working to develop and market Rytary outside of the U.S. and Taiwan. IPXL shares have yet to fully recover from a steep decline in March stemming from FDA concerns about the testing and evaluation process for Rytary. (PR)
Monday, March 4, 6:30 PM
Impax Laboratories (IPXL) gets hammered after FDA inspectors say they've found continuing problems at the company's Hayward, California manufacturing facility that may affect new and pending drug applications. Issues the agency found include problems related to the testing and evaluation processes for its Parkinson's drug candidate Rytary, as well as other products. Inspectors also said the company failed to identify the cause of broken tablets of its anti-inflammatory drug Carprofen. Shares -18.8% AH.
2 Comments[Healthcare, On the Move]
Monday, January 14, 2:32 PM
Investors interested in the prospects of young biotech companies might want to take a look at this Seeking Alpha article. It's a list of the upcoming FDA approval decision dates for Q1 2013, and with many of these developing firms having a good portion of their businesses riding on FDA approval decisions for their newly developed drugs, the stocks are likely to be sensitive to any positive or negative news over the near term.
Comment![Healthcare, Quick Ideas]
Tuesday, December 4, 2012, 10:11 AM
The patent cliff has been good for generic-drugs companies this year, with over 40 brand-name treatments with $35B of annual sales losing their IP protection. However, the sector faces its own patent cliff over the next couple of years, due to fewer drugs losing that protection. In response, the generic companies are specializing in treatments that are hard to make, selling their own branded medicines, or making big acquisitions.