New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 8, 2013
08:01 EDTSHPG, IPXLImpax, Shire settle litigation on supply of authorized generic Adderall XR
Impax Laboratories (IPXL) announced that it has settled all pending litigation with Shire LLC (SHPG) and Shire Laboratories, Inc.relating to supply of its authorized generic Adderall XR under the partiesí License and Distribution Agreement that was signed in January 2006. As part of the settlement, the parties will submit a stipulation of dismissal for entry by the Court. Shire has agreed to make a one-time cash payment to Impax of $48M upon the courtís order of dismissal. The parties have entered into an amended License and Distribution Agreement which will govern the future supply of authorized generic Adderall XR from Shire to Impax. Following the end of the supply term on September 30, 2014, Impax will continue to have the right to sell its products on hand or owed to it under the agreement until depleted and will continue to pay a profit share to Shire on sales of such products. Impax will continue to pursue approval of its pending Abbreviated New Drug Application for generic Adderall XR which was filed with the U.S. Food and Drug Administration in September 2003.
News For IPXL;SHPG From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
February 4, 2016
16:00 EDTSHPGShire's NDA for lifitegrast for dry eye resubmssion acknowledged by FDA
Shire announced that the FDA has acknowledged receipt of the resubmission of the New Drug Application for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act goal date of July 22.
February 3, 2016
08:07 EDTSHPGMedgenics names Brian Piper to succeed John Leaman as CFO
Subscribe for More Information
February 2, 2016
09:46 EDTSHPGIntercept rumored to draw interest from many suitors, Daily Mail says
Subscribe for More Information
07:36 EDTIPXLImpax receives tentative FDA approval for generic Vytorin ANDA
Impax Laboratories announced that Impax has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for the generic version of the ezetimibe and simvastatin containing tablets, in 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg and 10 mg / 80 mg strengths. "We are pleased to receive tentative approval from the FDA for our generic version of Vytorin tablets," said Fred Wilkinson, President and CEO. "We will continue to work with the FDA to gain final approval upon the expiration of the U.S. patents and associated pediatric exclusivity on April 25, 2017, and are currently planning to be among the first generic products to market."
January 28, 2016
10:05 EDTSHPGHigh option volume stocks
Subscribe for More Information
January 25, 2016
07:02 EDTSHPGShire resubmits NDA for lifitegrast to FDA
Subscribe for More Information
January 22, 2016
09:20 EDTSHPGShire completes acquisition of Dyax for $5.9B
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use