AbbVie Inc.'s (ABBV) investigational direct-acting antiviral combination regimen with and without Ribavirin for the treatment of genotype 1 hepatitis C virus infection has been designated as a Breakthrough Therapy by the FDA. The all-oral, direct-acting antivirals in the investigational HCV regimen are ABT-450, ABT-267 and ABT-333. ABT-450 is Enanta Pharmaceuticals Inc.'s (ENTA) lead HCV protease inhibitor identified in its ongoing collaboration with AbbVie.
According to the FDA, Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
ABBV closed Monday's trading at $44.59, down 0.20%.
Alnylam Pharmaceuticals Inc. (ALNY) has a couple of events lined up over the coming months. The company plans to file an Investigational New Drug application for ALN-AT3 for the treatment of hemophilia and other rare bleeding disorders in mid-2013.
The company also remains on track to start a phase III pivotal trial for ALN-TTR02 in familial amyloidotic polyneuropathy patients, and a phase II study of ALN-TTRsc in ATTR (amyloidogenic transthyretin) patients with familial amyloidotic cardiomyopathy by the end of 2013.
ALNY closed Monday's trading at $23.70, up 0.47%.
Array BioPharma Inc. (ARRY) said it will be initiating a global phase III trial of MEK162 in patients with recurrent low-grade serous ovarian cancer during the summer of 2013. MEK162 is also expected to advance into phase III studies in NRAS and BRAF melanoma this year.
ARRY closed Monday's trading at $5.80, down 2.36%.
Hill-Rom Holdings Inc.'s (HRC) latest advancement in airway clearance technology for enhanced patient care in the hospital, MetaNeb 4.0 System, has been given FDA clearance. According to the company, MetaNeb 4.0 System helps enhance normal mucus clearance from the lungs, delivers lung expansion therapy, and assists in the treatment and prevention of pulmonary atelectasis, a complete or partial collapse of the lung.
HRC gained 0.09% to close Monday's trading at $34.60.
CytRx Corp. (CYTR) has received recommendation from Data Safety Monitoring Committee to complete its international phase 2b clinical trial with Aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma. Data from the phase 2b trial is expected in the second half of 2013.
CYTR closed Monday's trading at $2.64, down 1.49%.
CEL-SCI Corp. (CVM) said that its LEAPS Vaccine has proved to be successful in reducing rheumatoid arthritis index score in a second animal model. According to the company, the LEAPS vaccine's effect was studied in the Proteoglycan induced arthritis, or PGIA, model of rheumatoid arthritis with a dominant T helper 1 cytokine profile.
CVM closed Monday's trading 1.23% higher at $0.28.
Masimo Corp. (MASI) on Monday said that its device rainbow Acoustic Monitoring sensor has received FDA clearance for continuous, noninvasive monitoring of acoustic respiration rate in pediatric patients. The device has already won FDA clearance for adult use.
MASI closed Monday's trading at $21.32, down 0.09%.
Merck & Co. Inc. (MRK) announced Monday its drug LIPTRUZET has been approved by FDA for the treatment of elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. LIPTRUZET is expected to be available for wholesalers to order the week of May 6.
MRK closed Monday's trading at $44.98, down 1.51%.
NuVasive Inc. (NUVA) has acquired ANC LLC, a spine implant manufacturer based in Dayton, Ohio for approximately $4.5 million. The transaction is expected to be neutral to earnings in fiscal year 2013.
NUVA closed Monday's trading 0.40% higher at $22.51.
Sagent Pharmaceuticals Inc. (SGNT) has agreed to acquire 50% interest of its joint venture partner, Chengdu Kanghong Pharmaceuticals Co. Ltd., in the Kanghong Sagent Pharmaceutical Corp. Ltd. joint venture, for $25 million, payable in installments through September 2015.
Upon completion of the acquisition, Kanghong Sagent Pharmaceutical Corp. Ltd. will become a wholly-owned subsidiary of Sagent, and the consolidated income statement is said to result in an incremental annual cost of $6 to $8 million through 2015.
SGNT shed 2.42% to close Monday's trading at $16.12.
Transgenomic Inc. (TBIO.OB) has entered into a collaboration with Amgen Inc. (AMGN) for developing CE-IVD CRC RAScan mutation detection tests for patients with metastatic colorectal cancer. Financial terms of the agreement were not revealed.
TBIO.OB closed Monday's trading at $0.38, up 1.35%.
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