CORAL SPRINGS, Florida, July 15, 2013 /PRNewswire/ --
FinancialNewsMedia.com issues market news updates for today's active healthcare companies Pharmacyclics, Inc. (Nasdaq: PCYC), Celldex Therapeutics, Inc. (Nasdaq:CLDX), Pfizer Inc. (NYSE: PFE) and Nu Skin Enterprises, Inc. (NYSE: NUS)
Pharmacyclics, Inc. (Nasdaq: PCYC) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The submission was based on data from Phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. With this submission, Pharmacyclics is also requesting Priority Review. Pharmacyclics is jointly developing ibrutinib with Janssen.
Read the entire press release at http://finance.yahoo.com/news/drug-application-ibrutinib-submitted-u-103000849.html
Celldex Therapeutics, Inc. (Nasdaq: CLDX) announced that the United States Patent and Trademark Office (USPTO) has issued US Patent No: 8,481,029 entitled "Human immune therapies using a CD27 agonist alone or in combination with other immune modulators" which broadly supports the Company's product candidate CDX-1127. CD27, a signaling molecule expressed on T lymphocytes, can be effectively manipulated with activating antibodies to induce potent anti-tumor responses and, due to the restricted expression and regulation of CD27, may result in less toxicity--overcoming a key barrier that other targets in this class have faced. CDX-1127 is a fully human monoclonal antibody (mAb) that targets CD27 and is currently in Phase 1 clinical development for the treatment of solid tumors and hematologic malignancies.
Read the entire press release at http://finance.yahoo.com/news/celldex-therapeutics-announces-issuance-seminal-110000546.html
Pfizer Inc. (NYSE: PFE) announced the company's pneumococcal conjugate vaccine, Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), received European approval for an expanded indication to include adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae (S. pneumoniae).(1) Previously approved in the European Union (EU) for use in infants, young children and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older, Prevenar 13 is now the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood.(1) The European Commission is the first to approve Prevenar 13 to offer protection against invasive disease at all stages of life.
Read the entire press release at http://finance.yahoo.com/news/pfizer-receives-european-approval-expand-100000517.html
Nu Skin Enterprises, Inc. (NYSE: NUS) announced a significant increase to estimated revenue and earnings per share for the second quarter of 2013. Revenue is now estimated to be about $680 million, with estimated earnings per share of approximately $1.20. Foreign currency fluctuations negatively impacted second-quarter revenue by approximately 3 percent. Prior revenue guidance was $570 to $580 million, with earnings per share guidance of $0.91 to $0.95. Additionally, the company announced that it is increasing its full-year 2013 revenue guidance by $320 million to $2.83 to $2.86 billion, including a negative 5 percent impact from foreign currency fluctuations. The company now expects 2013 earnings to be $4.85 to $5.00 per share.
Read the entire press release at http://finance.yahoo.com/news/nu-skin-enterprises-updates-second-205600657.html
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