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FDA approves SUTENT for treatment of pancreatic NET

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SUTENT® (sunitinib malate) as the first anti-VEGF therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide.

21 May 2011

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Salix Pharmaceuticals, Ltd. today announced findings from two analyses of a Phase 3 open-label study of RELISTOR (methylnaltrexone bromide) presented at the 30th Annual Scientific Meeting of the American Pain Society. The meeting is being held in Austin, TX, on May 19-21, 2011.

21 May 2011

FDA approves Sutent for patients with progressive neuroendocrine cancerous tumors in pancreas

The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

21 May 2011

EMA CHMP recommends conditional marketing authorization of FAMPYRA

The Committee for Medicinal Products for Human Use of the European Medicine Agency has recommended conditional marketing authorization of FAMPYRA (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability.

20 May 2011

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

20 May 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

20 May 2011

Jennerex presents positive preliminary data from JX-594 Phase 2 trial for advanced liver cancer

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the design, development and commercialization of first-in-class targeted oncolytic products for cancer, today presented preliminary data from a randomized dose-ranging Phase 2 trial of JX-594 in patients with advanced liver cancer showing a benefit in overall survival for the high dose group.

20 May 2011

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced results from the ASPIRE phase 2b study that evaluates the addition of once daily TMC435 to pegylated interferon and ribavirin in patients with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon (PegIFN) and ribavirin (RBV) was unsuccessful either because they relapsed, had a partial response or had a null response.

20 May 2011

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced results from a Phase 2b trial evaluating Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic breast cancer previously treated with a bevacizumab-containing regimen, which showed that Nexavar was associated with statistically significant improvements in progression-free survival and time-to-progression.

20 May 2011

Naltrexone improves clinical, inflammatory activity in Crohn's disease patients

Naltrexone reduced inflammation in Crohn's patients in a research study at Penn State College of Medicine.

20 May 2011

$Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma$

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced updated results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. Carfilzomib achieved a clinical benefit rate (CBR) (minimal response or greater) in the study population of 37 percent with a duration of response (DOR) of 8.3 months.

20 May 2011

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

ViroPharma Incorporated today announced initiation of a Phase 2 dose-ranging clinical study to evaluate the safety, tolerability, and efficacy of VP 20621 for prevention of recurrence of Clostridium difficile infection (CDI) in adults previously treated for CDI.

20 May 2011

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced that it has initiated a Phase 2 clinical trial of arhalofenate (MBX-102), its product candidate for the management of hyperuricemia in patients with gout.

19 May 2011

Omeros advances OMS103HP and OMS302 into Phase 3 clinical programs

Omeros Corporation today announced that it is advancing two of its product candidates from its PharmacoSurgery platform – OMS103HP for arthroscopic meniscectomy and OMS302 for intra-ocular lens replacement surgery – into Phase 3 clinical development programs.

19 May 2011

AstraZeneca announces encouraging results from olaparib phase II study in serous ovarian cancer

AstraZeneca announced today encouraging results from a phase II study in patients with platinum-sensitive relapsed serous ovarian cancer (SOC) who had received maintenance treatment with the investigational drug olaparib, after the completion of chemotherapy.

19 May 2011

TissueGene commences enrollment in TG-C Phase II trial for severe knee osteoarthritis

TissueGene, Inc. announced today that it has initiated patient enrollment for a U.S. Phase II clinical trial of its lead product candidate TG-C. TG-C involves human allogeneic chondrocytes developed to produce the therapeutic protein TGF-beta1 for the regeneration of cartilage in patients suffering from severe osteoarthritis of the knee.

19 May 2011

Aspirin, simvastatin not effective in combating pulmonary artery hypertension

Despite their beneficial effects in treating heart disease, neither aspirin nor simvastatin appear to offer benefit to patients suffering from pulmonary artery hypertension (PAH), according to a National Institutes of Health (NIH)-funded study conducted at four U.S. medical centers. This was the first NIH-funded randomized clinical trial (RCT) in PAH.

19 May 2011

Synergy expands GC-C agonist technology to lower cholesterol

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, announced today that it has successfully completed preclinical in vitro research demonstrating the inhibition of bile acid uptake by GC-C agonists and that it plans to commence animal studies shortly. Synergy believes this is the first time that GC-C agonists have been shown to potentially lower cholesterol.

18 May 2011

New data on personalized approaches for skin, ovarian and lung cancer to be presented at ASCO meeting

Genentech, a member of the Roche Group, today announced that data showing new personalized approaches for people with skin and lung cancer, plus new data with Avastin in ovarian cancer, will be presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

18 May 2011

Silodosin helps reduce chronic prostatitis in men

New findings show that treatment with a specific alpha blocker helps reduce symptoms and improve quality of life for men with chronic prostatitis/chronic pelvic pain syndrome.

18 May 2011

Placebo News and Research

FDA approves SUTENT for treatment of pancreatic NET

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

FDA approves Sutent for patients with progressive neuroendocrine cancerous tumors in pancreas

EMA CHMP recommends conditional marketing authorization of FAMPYRA

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Jennerex presents positive preliminary data from JX-594 Phase 2 trial for advanced liver cancer

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Naltrexone improves clinical, inflammatory activity in Crohn's disease patients

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

Omeros advances OMS103HP and OMS302 into Phase 3 clinical programs

AstraZeneca announces encouraging results from olaparib phase II study in serous ovarian cancer

TissueGene commences enrollment in TG-C Phase II trial for severe knee osteoarthritis

Aspirin, simvastatin not effective in combating pulmonary artery hypertension

Synergy expands GC-C agonist technology to lower cholesterol

New data on personalized approaches for skin, ovarian and lung cancer to be presented at ASCO meeting

Silodosin helps reduce chronic prostatitis in men

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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