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Oncolytics presents REO 013 clinical trial data for colorectal cancer at International Symposium in Spain

Oncolytics Biotech Inc. announced today that interim data from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases was presented at the International Symposium on Cytotoxic T-lymphocytes (CTL) and Immunostimulation being held in Pamplona, Spain.

27 Oct 2010

PPD and VirtualScopics partner to provide medical imaging services

PPD, Inc. and VirtualScopics, Inc. today announced a strategic alliance to deliver a comprehensive set of clinical and medical imaging services that will enable biopharmaceutical companies to make faster, more confident decisions on the development of their oncology compounds, creating time and cost efficiencies.

26 Oct 2010

Keryx completes randomization of last patient in Zerenex Phase 3 study for hyperphosphatemia

Keryx Biopharmaceuticals reported today the randomization of the last patient in its short-term study component of its Phase 3 registration program of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

26 Oct 2010

India's Trade Minister says EU will take steps to prevent seizure of generic medicines

"India believes a row with the European Union over seizures of generic drugs will be settled without litigation, Trade Minister Anand Sharma said on Wednesday," Reuters reports (Lynn, 10/20).

26 Oct 2010

Pfizer's Sutent stands as first-line setting for treating renal cell carcinoma: Survey

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of renal cell carcinoma (RCC), the majority of surveyed European oncologists who favor Pfizer's Sutent indicate that they would switch to an emerging therapy only if it extended progression-free survival (PFS) by at least an additional two to three months, assuming the agent's safety and tolerability profile was comparable to that of Sutent.

26 Oct 2010

Tengion presents data on Neo-Kidney Augment at Transplantation's Annual Scientific Exchange

Tengion, Inc. a leader in regenerative medicine, presented new data on Saturday, October 23, 2010 in a podium presentation at the American Society for Transplantation's Annual Scientific Exchange in Orlando, FL. The presentation highlighted new early data from Tengion's Neo-Kidney Augment development program demonstrating promising improvements in kidney function with an autologous cellular therapy approach to kidney regeneration in a canine model of chronic kidney disease.

26 Oct 2010

Karo Bio reports MSEK 0.0 (5.9) net sales for January-September 2010

Karo Bio Secures Funding of Approx. MSEK 530 to Enable Clinical Phase III Studies of Eprotirome.

26 Oct 2010

Phase II data from resminostat SAPHIRE study to be presented at International Hodgkin Lymphoma Symposium

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, announces the presentation of Phase II data from Hodgkin Lymphoma patients treated in the 1st Simon Stage cohort of the ongoing SAPHIRE study with resminostat (4SC-201), an oral pan-histone deacetylase (HDAC) inhibitor, at the 8th International Symposium on Hodgkin Lymphoma in Cologne, Germany.

26 Oct 2010

Celtic, Resolvyx enter option agreement for RX-10045 to treat dry eye syndrome

Celtic Therapeutics Holdings L.P. a successor firm to Celtic Pharma, and Resolvyx Pharmaceuticals, Inc. (Resolvyx) announced today that they have entered into an option agreement relating to Resolvyx's RX-10045, a late-stage program for the treatment of dry eye syndrome and other ophthalmic conditions.

26 Oct 2010

Sanofi-aventis commences teriflunomide Phase III study in RMS patients treated with interferon beta

Sanofi-aventis announced today the initiation of a multinational Phase III study evaluating the efficacy and safety of two doses of once daily teriflunomide (7mg or 14mg) versus placebo in patients with relapsing multiple sclerosis (RMS) treated with interferon beta (IFN beta).

26 Oct 2010

LigoCyte presents Phase I/II study results of NoV vaccine for gastroenteritis at IDSA Meeting

LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company developing innovative vaccine products, today announced positive results from a Phase I/II challenge study of its norovirus virus-like particle (VLP) vaccine candidate.

26 Oct 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

S.A.N.E. Vax requests temporary suspension of Gardasil sales as cervical cancer preventive

In a letter addressed to Dr. Margaret Hamburg, the FDA commissioner, Ms. Norma Erickson, president of S.A.N.E. Vax, Inc. stated her research team has revealed the fact that in November 2001 the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed the vaccine manufacturer to use "CIN 2/3, AIS, or cervical cancer; i.e. CIN 2/3 or worse by histology- with virology to determine the associated HPV type- as the primary endpoint in the evaluation of a vaccine to prevent cervical cancer."

25 Oct 2010

Repros commences randomization in Androxal Phase II study in T2DM men with low testosterone

Repros Therapeutics Inc. today announced it has commenced randomization of subjects into its Phase II Androxal® study in the treatment of type 2 diabetes (T2DM) in men with low testosterone. Low testosterone and T2DM are co-morbid conditions in a significant number of men. The study is being conducted at nine sites across the US including both academic and private practices and will enroll up to 150 patients.

25 Oct 2010

First implantation of Neo-Urinary Conduit in bladder cancer patient performed at University of Chicago

Tengion, Inc., a leader in regenerative medicine, announced today that surgeons at the University of Chicago have implanted its Neo-Urinary Conduit™ in the first patient as part of the ongoing clinical trial evaluating the Company's lead product candidate in bladder cancer patients requiring a urinary diversion following bladder removal.

25 Oct 2010

GSN initiates trial of microarray PGD on pregnancy and implantation rates in IVF

Gene Security Network (GSN) announced today that it has initiated enrollment for a prospective randomized trial in collaboration with Ferring Pharmaceuticals to evaluate the impact of GSN's advanced preimplantation genetic diagnosis (PGD) with Parental Support™ on pregnancy and implantation rates in IVF.

25 Oct 2010

New Canadian Cardiovascular Society guidelines support clinicians in practicing evidence-based medicine

Summaries of a number of new Canadian Cardiovascular Society guidelines and position statements offering the most up to date information to support clinicians in practicing evidence-based medicine were released at the Canadian Cardiovascular Congress 2010 this week.

25 Oct 2010

NovaBay delivers two poster presentations on Aganocide compounds at IDSA Annual Meeting

NovaBay Pharmaceuticals, Inc. a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, delivered two poster presentations on its compounds at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Vancouver, Canada.

25 Oct 2010

Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides

Essentialis, Inc. announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 efficacy study required for product registration for its product candidate, Diazoxide Choline Controlled Release Tablet (DCCR), for the treatment of patients with very high triglycerides.

25 Oct 2010

FDA warns about risk of Hyland's Teething Tablets to children

The U.S. Food and Drug Administration today is warning consumers that Hyland's Teething Tablets may pose a risk to children. The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product.

25 Oct 2010

Efficacy News and Research

Oncolytics presents REO 013 clinical trial data for colorectal cancer at International Symposium in Spain

PPD and VirtualScopics partner to provide medical imaging services

Keryx completes randomization of last patient in Zerenex Phase 3 study for hyperphosphatemia

India's Trade Minister says EU will take steps to prevent seizure of generic medicines

Pfizer's Sutent stands as first-line setting for treating renal cell carcinoma: Survey

Tengion presents data on Neo-Kidney Augment at Transplantation's Annual Scientific Exchange

Karo Bio reports MSEK 0.0 (5.9) net sales for January-September 2010

Phase II data from resminostat SAPHIRE study to be presented at International Hodgkin Lymphoma Symposium

Celtic, Resolvyx enter option agreement for RX-10045 to treat dry eye syndrome

Sanofi-aventis commences teriflunomide Phase III study in RMS patients treated with interferon beta

LigoCyte presents Phase I/II study results of NoV vaccine for gastroenteritis at IDSA Meeting

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

S.A.N.E. Vax requests temporary suspension of Gardasil sales as cervical cancer preventive

Repros commences randomization in Androxal Phase II study in T2DM men with low testosterone

First implantation of Neo-Urinary Conduit in bladder cancer patient performed at University of Chicago

GSN initiates trial of microarray PGD on pregnancy and implantation rates in IVF

New Canadian Cardiovascular Society guidelines support clinicians in practicing evidence-based medicine

NovaBay delivers two poster presentations on Aganocide compounds at IDSA Annual Meeting

Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides

FDA warns about risk of Hyland's Teething Tablets to children

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