|Bristol's BRISK-FL Study Did Not Meet Survival Primary Endpoint; Amarin Responds to Erroneous Website Posting|
|By Staff and Wire Reports|
|Thursday, 19 July 2012 18:56|
Bristol-Myers Squibb Company (NYSE: BMY) reported results of the phase III BRISK-FL clinical trial of the investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma (HCC; liver cancer).
The study did not meet its primary overall survival objective based upon a non-inferiority statistical design. BRISK-FL is a randomized, double-blind, multi-center phase III study of the investigational agent brivanib versus sorafenib in patients with advanced HCC who have not received prior systemic treatment. Bristol-Myers Squibb and the lead investigators plan to present the findings of the study at an upcoming scientific meeting.
On July 19, 2012, information related to AMR101, Amarin Corporation (NASDAQ: AMRN) plc's lead product candidate, and its pending regulatory review with the U.S. FDA was inadvertently published through a draft website that is under design by third parties on behalf of Amarin. The information was outdated and should not be relied upon as accurate. AMR101 review at FDA is still pending. No determinations have been made by FDA on its review of the AMR101 New Drug Application.
Amarin plans to announce news related to a final determination by FDA on the pending AMR101 NDA when appropriate. As previously announced, the FDA has assigned a Prescription Drug User Fee Act date of July 26, 2012 as the target date for the completion of FDA review of the pending AMR101 NDA. Please refer to Amarin's other filings with the U.S. Securities and Exchange Commission for a complete discussion regarding the risks and uncertainties regarding the pending AMR101 NDA.
Allezoe Medical Holdings (OTCBB:ALZM) today announced that it has entered into an agreement for the merger of HealthWatch Systems, Inc., a Florida corporation, with and into HWS Acquisition Corp., a Florida corporation and wholly-owned acquisition subsidiary of ALZM.
DoMark International Inc. (OTCBB:DOMK), through its wholly owned subsidiary, MuscleFoot Inc., is pleased to announce that Nick Symmonds, five-time reigning American 800 meter Champion, two-time World Championship 800 meter finalist, and 2012 Olympic team USA member, has agreed to an endorsement contract with the Company.
EncounterCare Solutions, Inc. (PINKSHEETS: ECSL) announced today that Authentidate Holding Corporation, a non-exclusive licensee of its Electronic House Call Technology, has obtained approval from the Department of Veterans Affairs for national implementation of the EHC in its system.
Hologic, Inc. (NASDAQ: HOLX) announced today the pricing of its private placement of $1.0 billion in aggregate principal amount of its 6.25% Senior Notes due 2020 (the "Notes").
Life Technologies Corporation (NASDAQ: LIFE) today announced it has signed a collaborative partnership with the Structural Genomics Consortium (SGC), and several groups of leading expert scientists in antibody technology at the Universities of Chicago and Toronto, to generate a first-ever master set of quality epigenetic recombinant antibodies for use in disease-related research.
NeoGenomics, Inc. (NASD OTC QB: NGNM), a leading provider of cancer-focused genetic testing services today reported its results for the second quarter 2012.
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced it is the first contract research organization (CRO) chosen by the Korea Drug Development Fund (KDDF) to help Korean companies develop and commercialize healthcare products for the global market.
PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced that the Company will release its second quarter financial results for the period ended June 30, 2012, on Thursday, August 2, 2012, after the market close.
United Therapeutics Corporation (NASDAQ: UTHR) announced today that it will release its second quarter 2012 financial results before market open on Thursday, July 26, 2012.