BIOLASE Inc. (BIOL: Quote), a biomedical company that markets lasers, dental imaging equipment and other products for use in dentistry and medicine, has hit a new milestone – the sale of its 25,000th laser into the dental market.
Since receiving clearance for its revolutionary WaterLase technology from the FDA in October 1998, over 10,000 WaterLase and 15,000 diode lasers have been sold, according to the company.
BIOL closed Monday’s trading 10.16% higher at $3.36.
Bristol-Myers Squibb Co.’s (BMY: Quote) investigational DCV Dual Regimen for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection has been granted Breakthrough Therapy Designation by FDA.
A phase III trial of an all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin is currently underway.
BMY closed Monday’s trading at $54.31, up 0.31%.
Cellular Biomedicine Group Inc.’s (CBMG.OB) phase I/IIa clinical trial for ReJoin, a human adipose-derived mesenchymal precursor cell therapy for Knee Osteoarthritis, has demonstrated statistically significant improvement in Knee Osteoarthritis scores, as can be seen by significantly reduced knee pain, improved knee mobility, and prolonged walking distance.
A pase IIb clinical trial of ReJoin for treatment of Knee Osteoarthritis is currently underway.
CBMG.OB closed Monday’s trading at $5.02, down 8.73%.
Cesca Therapeutics Inc. (KOOL: Quote), formerly known as ThermoGenesis Corp., has chosen Cook Medical as the supplier for select delivery device products for its AMIRST (Acute Myocardial Infarction Rapid Stem cell Therapy) phase Ib trial set to begin later this calendar year.
The clinical trial is for targeted marketing approval in the United States, European Union Community and India.
KOOL closed Monday’s trading at $2.37, down 1.25%.
Celsion Corp. (CLSN: Quote) has received the go-ahead from FDA for its planned pivotal, double-blind, placebo-controlled phase III trial of ThermoDox in primary liver cancer, dubbed OPTIMA. The company expects to launch the study in the first half of 2014.
The OPTIMA Study is expected to enroll 550 patients globally, with up to 100 sites in the United States, Europe, China and Asia Pacific and will evaluate ThermoDox in combination with radio frequency ablation.
CLSN rose 3.59% to close Monday’s trading at $3.75. In extended trading, the stock gained 0.80% to $3.78.
Endocyte Inc. (ECYT: Quote) is scheduled to report top-line data from a phase IIb trial of investigational diagnostic imaging agent Etarfolatide and investigational cancer candidate Vintafolide in non-small cell lung cancer, dubbed TARGET, in March.
In a phase III registration trial of Vintafolide and Etarfolatide in ovarian cancer, known as PROCEED, patient enrollment remains on track, and the enrollment of the 250th patient is expected in the second quarter.
ECYT rose 4.75% on Monday to close the day’s trading at $15.65.
Regeneron Pharmaceuticals Inc. (REGN: Quote) touched an all-time high of $348.25 on Monday before closing at $347.62, following positive regulatory news.
The company’s supplemental Biologics License Application for EYLEA Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion has been accepted for standard review by FDA, with a decision slated for October 23, 2014.
EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has also been approved in the European Union (EU) and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in the U.S. and the EU for EYLEA for the treatment of Diabetic Macular Edema.
EYLEA raked in net sales of $1.409 billion in the U.S. in 2013, compared to $838 million in 2012. The net sales of EYLEA outside of the United States were $472 million in 2013, up from $19 million in 2012.
RTI Surgical Inc. (RTIX: Quote) has launched 2 systems – MaxFuse Vertebral Body Replacement System and Aspect Anterior Cervical Plate System – for use in spine fusion in the U.S.
MaxFuse VBR System received FDA clearance in December of 2013 while the Aspect system got the regulatory clearance in June 2013.
RTIX dropped 3.12% to close Monday’s trading at $3.72.
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