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Anthera initiates PEARL-SC Phase 2b study of A-623 for lupus

Anthera Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has initiated PEARL-SC, the Phase 2b study of A-623, a novel inhibitor of B-Cell Activating Factor, or BAFF, for the treatment of Systemic Lupus Erythematosus (lupus). Lupus patients suffer from a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain, major organ complications, and cardiovascular disease.

30 Jul 2010

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos Therapeutics, Inc. today announced topline results from the Company's randomized Phase 2b investigational trial of FOLOTYN® (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) who had received one or two prior systemic treatments including at least one prior platinum-based regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival.

28 Jul 2010

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

Healthcare Labor Update 2010: A year of critical opportunity for employers

When labor unions, particularly the Service Employee International Union (SEIU), spent hundreds of millions during the last presidential election cycle - resulting in a labor-friendly Democratic Administration and Congressional majority for the first time in a decade - it appeared the labor movement was poised to make a swift resurgence.

26 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Preventative measures to avoid Lyme disease

Research on the population of black-legged ticks, which can transmit Lyme disease from host animals to humans, reinforces that it is important to take preventative measures when spending time outdoors.

21 Jul 2010

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Medivir announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).

12 Jul 2010

Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

7 Jul 2010

Clemizole can yield high-level synergy with protease inhibitor class: Research

Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced today the publication of research from the lab of Stanford scientist and Eiger Founder, Dr. Jeffrey Glenn, M.D., Ph.D. and colleagues entitled, "The Hepatitis C Virus (HCV) NS4B RNA Binding Inhibitor Clemizole is Highly Synergistic with HCV Protease Inhibitors".

2 Jul 2010

Combination MMRV vaccine associated with increased risk of febrile seizures

The combination vaccine for measles, mumps, rubella and chickenpox (MMRV) is associated with double the risk of febrile seizures for 1- to 2-year-old children compared with same-day administration of the separate vaccine for MMR (measles, mumps, rubella) and the varicella (V) vaccine for chicken pox, according to a Kaiser Permanente Division of Research study appearing online in the journal Pediatrics. A febrile seizure is a brief, fever-related convulsion but it does not lead to epilepsy or seizure disorders, researchers explained.

28 Jun 2010

NanoViricides' anti-Dengue drug candidates demonstrate potential against severe virus infection

NanoViricides, Inc. reports that its anti-Dengue drug candidates demonstrated significant protection in the initial animal survival studies of Dengue virus infection. The studies were performed in the laboratory of Dr. Eva Harris, Professor of Infectious Diseases at the University of California, Berkeley.

21 Jun 2010

Effects of SLE may differ based on patient's genealogical heritage: Study

The effects of Systemic Lupus Erythematosus may differ based on the individual patient's genealogical heritage, according to results of a new study presented today at EULAR 2010, the Annual Congress of the European League Against Rheumatism in Rome, Italy. In particular, the study reinforced differences in SLE phenotype found between Northern and Southern European subpopulations.

18 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

FDA grants orphan drug designation for ICT-107

ImmunoCellular Therapeutics announced today that the U.S. Food and Drug Administration has granted orphan drug designation for ICT-107, the company's dendritic cell-based cancer vaccine candidate which targets glioblastoma multiforme. As a result of the orphan drug status, ImmunoCellular will be eligible to receive a number of benefits, including access to grant funding for clinical trials, tax credits, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of up to seven years.

11 Jun 2010

Interim results from PROPEL study of RG7128 submitted as abstract to AASLD for Annual Liver Meeting

Pharmasset, Inc. announced today that the interim results from the PROPEL study conducted by its partner Roche demonstrate that RG7128 triple combination therapy was safe and well tolerated. In that study, the safety profile of RG7128 (1000mg BID or 500mg BID), when administered for 8 or 12 weeks with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), the standard of care, was similar to the safety profile of SOC alone.

9 Jun 2010

Clinical trials of four investigational compounds in solid tumors presented at ASCO Annual Meeting

Millennium: The Takeda Oncology Company today announced data from clinical trials of four investigational compounds in solid tumors presented at the Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois, June 4-8, 2010. These data include an oral presentation on MLN8237, the Company's selective Aurora A kinase inhibitor.

9 Jun 2010

Vandetanib extends Progression Free Survival in ZETA phase III study for advanced medullary thyroid cancer

Results from ZETA, a phase III study in patients with advanced medullary thyroid cancer (MTC), showed that treatment with the investigational drug vandetanib significantly extended Progression Free Survival (PFS), the primary endpoint of the study, by demonstrating a 54% reduction in the rate of progression compared to placebo.

8 Jun 2010

Interim data from multiple ongoing trials of XL147 PI3K inhibitor to be presented at ASCO 2010

Exelixis, Inc. today reported updated interim data from three ongoing trials of XL147 (SAR245408), a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K). Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy.