BioDelivery Sciences (BDSI) U.S. Re-Launch of ONSOLIS Postponed Mar 12, 2012 08:00AM

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) has announced that the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two appearance issues raised by the U.S. Food and Drug Administration (FDA) following a recent inspection of the Aveva manufacturing facility where ONSOLIS is produced.

The discussion with FDA centered on the formation of microscopic crystals and a slight fading of the color during the 24-month shelf life of the product. While these changes do not affect the product's underlying integrity or safety, the FDA believes that the fading of the color in particular may potentially confuse patients, necessitating a modification of the product and product specification before additional product can be manufactured and distributed.

An analysis by BDSI points to these changes being related to a specific excipient used in the manufacturing process that can be removed to resolve the problem. Importantly, the excipient in question is specific to the manufacture of ONSOLIS in the U.S. and is not used in the manufacturing process for BDSI's other products, BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX), where such developments have never been noted. In addition, it is not expected to impact the launch of BREAKYL (brand name for ONSOLIS in E.U.) later this year. BDSI intends to provide further guidance related to timing of resolution of this matter as discussions continue with FDA and additional information becomes available.


Clearwire (CLWR) Announces Senior Debt Offering Jan 24, 2012 08:38AM

Clearwire Corporation (Nasdaq: CLWR) today announced that its operating subsidiary, Clearwire Communications LLC ("Clearwire Communications"), intends to offer $300 million aggregate principal amount of first-priority senior secured notes (the "Notes"). The Notes will be senior secured obligations of the Company and will be guaranteed on a first-priority lien basis by certain of the Company's domestic subsidiaries.


Radisys (RSYS) Issues HSPA+ Enhancements to Trillium Femtotality Solution Dec 5, 2011 04:08PM

Radisys Corporation (Nasdaq: RSYS), announced Evolved High-Speed Packet Access (HSPA+) performance enhancements to its award-winning Trillium Femtotality solution, a complete and portable application and protocol software suite for 3G small cells. Radisys’ Trillium Femtotality with HSPA+ is the first small cell solution enabling mobile operators increased performance and throughput, delivering speeds up to 21Mbps downlink and 5.76Mbps uplink.


Hynix Semi Renews License Agreement with Tessera (TSRA) Nov 23, 2011 06:34AM

Tessera Technologies, Inc. (Nasdaq: TSRA) reports Hynix Semiconductor Inc. exercised the renewal option in its March 31, 2005 license agreement with Tessera, Inc. to extend the term of that license to May 22, 2017.


Lockheed Martin Corp. (LMT) Tops Q3 EPS by 18c; Boosts FY11 EPS Outlook Oct 26, 2011 07:32AM

Lockheed Martin Corp. (NYSE: LMT) reported Q3 EPS of $1.99, $0.18 better than the analyst estimate of $1.81. Revenue for the quarter came in at $12.1 billion versus the consensus estimate of $11.73 billion.

Lockheed Martin Corp. sees FY2011 EPS of $7.40-$7.60, versus prior guidance of $7.35-$7.55 and the consensus of $7.52.


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