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Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Osiris Therapeutics, Inc. today announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for completing enrollment in a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell (MSC) therapy, as a treatment for patients recently diagnosed with type 1 diabetes. The milestone is the fourth in a series of payments resulting from JDRF’s partnership with Osiris for the development of a therapy for type 1 diabetes.

27 Jan 2010

Dynavax Technologies to present data on its SD-101 Phase 1b trial for chronic HCV infection

Dynavax Technologies Corporation announced today data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist is well tolerated and safe and induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.

27 Jan 2010

Curemark commences CM-AT Phase III autism clinical trial enrollment at ten sites

Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced that the company is now enrolling patients in Phase III clinical trials for CM-AT, its autism treatment, at ten sites across the country.

27 Jan 2010

YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

YM BioSciences Inc., announced that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively and the other in patients with brain metastases from NSCLC. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone.

27 Jan 2010

Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies’ long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.

25 Jan 2010

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients.

24 Jan 2010

Pfizer reports final results from randomized Phase 3 trial of Sutent

Pfizer Inc. today announced final results from a randomized Phase 3 trial of Sutent (sunitinib malate) in patients with advanced pancreatic neuroendocrine tumors, a type of cancer which originates in the hormone-producing area of the pancreas.

23 Jan 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

Progress in Anadys Pharmaceuticals' Phase II study of ANA598 announced

Anadys Pharmaceuticals, Inc. today announced that ANA598 dosing has been completed in the first dose cohort, 200 mg bid, in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients.

22 Jan 2010

CMO to manufacture Gaia BioPharma's GAI-122 Mitochondria-targeted neuroprotective agent

AlphaRx Inc. announced today that its licensee, Gaia BioPharma Limited, has signed an agreement with a contract manufacturing organization (CMO), to manufacture GAI-122 for use in the planned Phase I and II clinical trials of that product candidate. GAI-122 is being developed as I.V. administered formulation of an intracellular neuroprotectant that employs AlphaRx's proprietary nano-emulsion formulation technology.

22 Jan 2010

Ipsen and Inspiration Biopharmaceuticals form strategic partnership

Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today announced the formation of a strategic partnership between Ipsen and Inspiration Biopharmaceuticals ("Inspiration") to create a world leading hemophilia franchise, an important milestone for the Celtic Pharma portfolio.

21 Jan 2010

Amgen announces results of two Phase 3 studies evaluating Vectibix for mCRC

Amgen today announced that detailed results from two pivotal Phase 3 studies evaluating Vectibix® (panitumumab) in combination with chemotherapy for the first and second-line treatment of metastatic colorectal cancer (mCRC) (the PRIME '203' and '181' trials, respectively) will be presented at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in Orlando, Florida from Jan. 22-24, 2010.

21 Jan 2010

China Pharma Holdings announces completion of clinical trials for Candesartan

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA.

21 Jan 2010

Elevation Pharmaceuticals closes $30M tranched Series A financing

Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today the closing of a $30 million tranched Series A financing.

21 Jan 2010

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Pharmasset, Inc. today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

21 Jan 2010

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

BioNumerik Pharmaceuticals, Inc. today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer.

21 Jan 2010

Results of two pivotal Phase III clinical trials with oral FTY720 published

Results of the TRANSFORMS and FREEDOMS studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety profile of this first-in-class therapy for multiple sclerosis (MS).

21 Jan 2010

Phase 3 clinical trial results of Inspire Pharmaceuticals' PROLACRIA announced

Inspire Pharmaceuticals, Inc. announced today that its Phase 3 clinical trial (Trial 03-113) of PROLACRIA™ (diquafosol tetrasodium ophthalmic solution) 2% for the treatment of dry eye disease did not meet its primary endpoint (p = 0.526) or its secondary endpoint (p = 0.368).

21 Jan 2010

IMUC’s ICT-107 vaccine product candidate targets cancer stem cells

ImmunoCellular Therapeutics today announced the results of a study in which it was shown that certain specific antigens are highly expressed on cancer stem cells (CSCs). This suggests that IMUC’s lead cancer vaccine product candidate ICT-107, which targets those antigens, may effectively target not only the cells that make up the bulk of certain cancerous tumors, but also the CSCs that are widely believed to give rise to them and cause their recurrence.

21 Jan 2010

EMD Serono announces results from CLARITY Phase III trial in MS patients

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today the online publication of the results from the CLARITY Phase III trial using Cladribine Tablets (EMD Serono's proprietary investigational oral formulation of cladribine) in The New England Journal of Medicine. The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in 1,326 people with relapsing-remitting multiple sclerosis (MS).

21 Jan 2010

Drug Trial News

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Dynavax Technologies to present data on its SD-101 Phase 1b trial for chronic HCV infection

Curemark commences CM-AT Phase III autism clinical trial enrollment at ten sites

YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Pfizer reports final results from randomized Phase 3 trial of Sutent

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Progress in Anadys Pharmaceuticals' Phase II study of ANA598 announced

CMO to manufacture Gaia BioPharma's GAI-122 Mitochondria-targeted neuroprotective agent

Ipsen and Inspiration Biopharmaceuticals form strategic partnership

Amgen announces results of two Phase 3 studies evaluating Vectibix for mCRC

China Pharma Holdings announces completion of clinical trials for Candesartan

Elevation Pharmaceuticals closes $30M tranched Series A financing

Pharmasset commences PSI-7977 Phase 2a trial for HCV

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

Results of two pivotal Phase III clinical trials with oral FTY720 published

Phase 3 clinical trial results of Inspire Pharmaceuticals' PROLACRIA announced

IMUC’s ICT-107 vaccine product candidate targets cancer stem cells

EMD Serono announces results from CLARITY Phase III trial in MS patients

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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