ICPT Unveils New Data, BIO Opens Wallet, COV Recalls Devices, IPXL Resubmits NDA

(RTTNews) - Bio-Rad Laboratories, Inc (BIO) has acquired privately-held GnuBIO, a life sciences company that has developed a droplet-based DNA sequencing technology. The terms of the deal are not known. The acquisition will help Bio-Rad to expand its Digital Biology Center and establish a research and development site in Cambridge, Massachusetts.

BIO closed Friday's trading at $120.08, down 2.14%.

Covidien plc (COV)is recalling certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene coating applied to the delivery wire could delaminate and detach from the devices.

The Pipeline Embolization Device is indicated for the endovascular treatment of adults aged 22 years and older with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator Retrieval Device is intended for use in the peripheral and neuro-vasculature for foreign body retrieval.

The company noted that a total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices, manufactured and distributed from May 2013 to March 2014, are affected by this recall. The products were sold in the U.S., Australia, France, Germany and United Kingdom, and the Alligator Retrieval Device, which is sold in the U.S., Australia, Canada, Europe and Latin America.

COV closed Friday's trading at $69.03, down 1.65%.

Intercept Pharmaceuticals Inc.'s (ICPT) phase III trial of its lead product candidate, OCA, for the treatment of primary biliary cirrhosis, dubbed POISE, has demonstrated notable improvements on key endpoints - achieving a highly statistically significant reduction in alkaline phosphatase - as early as two weeks, with a peak effect achieved by six months.

Last month, the company announced that the POISE trial met the primary endpoint with high statistical significance.

The company plans to make regulatory filings for OCA, seeking approval of the product in the U.S. and Europe by the end of this year.

ICPT closed Friday's trading at $266.01, up 0.50%.

Impax Laboratories Inc. (IPXL) has resubmitted its New Drug Application for RYTARY, an investigational drug for the symptomatic treatment of Parkinson's disease, to FDA.

RYTARY was issued a complete response letter last January and the FDA had sought for a satisfactory re-inspection of the company's Hayward facility as a result of the warning letter issued in May 2011.

The FDA has designated the NDA filing for RYTARY as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.

Impax had a collaboration with GlaxoSmithKline for RYTARY that was signed in 2010, under which GSK had the right to develop and commercialize the product outside the U.S. and Taiwan. But this collaboration was terminated by GSK in April 2013 due to delays in the anticipated regulatory approval and launch dates in countries in which the pharma giant had rights to commercialize RYTARY.

IPXL closed Friday's trading 0.70% higher at $24.55.