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Immunomedics product candidates, technologies receive recognition from QTDP program

Immunomedics, Inc. a biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that all 12 applications from the Company were certified by the Internal Revenue Service of the Department of Treasury as qualified investments in accordance with the Qualifying Therapeutic Discovery Project (QTDP) program under section 48D of the Internal Revenue Code. As a result, the Company will receive an aggregate cash award of $2.9 million.

3 Nov 2010

Avila presents results of AVL-192 preclinical studies for HCV infection at AASLD Meeting

Avila Therapeutics, Inc., a biotechnology company developing novel targeted covalent drugs, presented results today of preclinical studies that demonstrate its orally-available targeted covalent drug candidate, AVL-192, achieves superior potency against drug-resistant mutations of the Hepatitis C Virus (HCV). These new data were presented today at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) international meeting in Boston, Massachusetts.

3 Nov 2010

Enzon receives $1.2 million in funding under IRS Qualifying Therapeutic Discovery Project program

Enzon Pharmaceuticals, Inc. today announced that it has been awarded $1.2 million in funding under the IRS Qualifying Therapeutic Discovery Project (QTDP) program, which was created by Congress as part of the Patient Protection and Affordable Care Act of 2010.

3 Nov 2010

ImmunoGen to present clinical data of lead compounds at EORTC-NCI-AACR Symposium

ImmunoGen, Inc. a biotechnology company that develops targeted antibody-based anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced that several ImmunoGen poster presentations will be made at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics to be held in Berlin, Germany, November 16-19, 2010.

3 Nov 2010

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

Hyperion Therapeutics, Inc. today announced that the Company's phase III pivotal study of glycerol phenylbutyrate (HPN-100), an investigational drug for the treatment of urea cycle disorders (UCDs), met its primary endpoint. The non-inferiority study, conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA) in June 2009, evaluated the ammonia control of glycerol phenylbutyrate as compared to sodium phenylbutyrate (BUPHENYL®).

3 Nov 2010

BioCancell reports results of BC-819 Phase I/IIa clinical trial for pancreatic cancer

Tikcro Technologies Ltd. today announced that BioCancell reported results from a Phase I/IIa clinical trial to establish the safety, optimal dose and preliminary efficacy of BioCancell's lead drug-candidate, BC-819, as a treatment for pancreatic cancer.

3 Nov 2010

Bristol-Myers extends time to review BLA for ipilimumab in melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has determined that additional time is required to complete the review of the biologics license application (BLA) for ipilimumab in pre-treated advanced melanoma, and has moved its decision date from December 25, 2010 to March 26, 2011.

3 Nov 2010

NeurogesX initiates NGX-1998 Phase 2 study in postherpetic neuralgia

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced dosing of the first patient in its Phase 2 clinical study of NGX-1998, a liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).

3 Nov 2010

CytRx receives nontaxable grant under Qualifying Therapeutic Discovery Project Program

CytRx Corporation a biopharmaceutical company specializing in oncology, today announced that it has been awarded a nontaxable grant of approximately $735,000 related to its INNO-206, tamibarotene and bafetinib programs under the Qualifying Therapeutic Discovery Project Program included in the Patient Protection and Affordable Care Act, H.R. 3590, signed into law in March 2010.

3 Nov 2010

Nile announces results of CD-NP Phase 2 study in renally compromised ADHF patients

Nile Therapeutics, Inc. a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced results of its Phase 2 study evaluating its lead compound CD-NP in patients with acute decompensated heart failure (ADHF) and mild to moderate renal insufficiency. Study results demonstrated that multiple doses were characterized as well tolerated with favorable drug activity in this acute patient population.

3 Nov 2010

Combining telaprevir regimen with standard therapy improves SVR rate in hepatitis C

For patients with the most common form of hepatitis C being treated for the first time, the addition of an investigational hepatitis C-specific protease inhibitor called telaprevir to the current standard therapy markedly improved their sustained viral response (SVR or viral cure) rate.

3 Nov 2010

Asthmatx presents 2-year results from AIR2 Trial of bronchial thermoplasty in severe asthma

Boston Scientific Corporation today announced that its newly acquired subsidiary, Asthmatx, Inc., presented two-year results from the Asthma Intervention Research 2 (AIR2) Trial demonstrating the long-term safety and effectiveness of bronchial thermoplasty (BT) in adult patients with severe asthma.

2 Nov 2010

NPS third quarter net loss increases to $15.7 million

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported its results for the third quarter 2010.

2 Nov 2010

RegeneRx announces positive results from RGN-259 non-clinical study for Dry Eye Syndrome

RegeneRx Biopharmaceuticals, Inc. today announced the results of its first non-clinical dry eye study using RGN-259, RegeneRx's ophthalmic, preservative-free eye drop for the treatment of Dry Eye Syndrome (DES). In the study, animals were treated with RGN-259, a vehicle control and a positive control, doxycycline.

2 Nov 2010

Inhibitex to present INX-189 data for HCV infections at AASLD Meeting

Inhibitex, Inc. announced today that three posters describing preclinical data on INX-189, the Company's nucleotide polymerase inhibitor in clinical development for the treatment of chronic hepatitis C (HCV) infections, will be presented by various scientists from the Company at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA.

2 Nov 2010

TriRima shows positive result in food-induced cardiovascular effects associated with MAO inhibitors

CeNeRx BioPharma, Inc., today announced that a new formulation of TriRima, its lead agent for treatment resistant depression, showed excellent safety in a study designed to test whether it is free of the food-induced cardiovascular effects associated with conventional MAO inhibitors.

2 Nov 2010

Soligenix completes enrollment in RiVax Phase 1B ricin toxin clinical trial

Soligenix, Inc., a late-stage biopharmaceutical company, reported today that it has completed enrollment of its Phase 1B clinical trial of RiVax™, a ricin subunit vaccine, in healthy volunteers. Preliminary results indicate that RiVax™ appears safe at all doses tested in volunteers. This trial is designed to assess the duration of immune responses using an adjuvant formulation of RiVax™ over a period of more than one year after vaccination.

2 Nov 2010

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

Protalix BioTherapeutics, Inc., announced today positive preliminary data from the first 15 patients that completed the Company's nine month, worldwide, multi-center, open-label, switchover trial of taliglucerase alfa for the treatment of Gaucher disease under a protocol cleared by the U.S. Food and Drug Administration (FDA). The data indicate that patients can safely be switched to taliglucerase alfa from imiglucerase (Cerezyme®).

2 Nov 2010

ADVANCE Phase 3 study confirms clinical benefits of telaprevir regimen in patients with HCV infection

The Phase 3 results from the ADVANCE study confirm the clinical benefits of telaprevir-based combination therapy regimens. The study reports an improvement in treatment discontinuation rates due to adverse events compared to Phase 2 studies, and demonstrates an increase in sustained viral response (SVR) in patients with hepatitis C virus (HCV). The primary endpoint for this study was SVR 24 weeks after last treatment.

2 Nov 2010

Boceprevir combinational therapy improves SVR rate in patients with HCV genotype 1

The final results of the RESPOND-2 trial demonstrated that combination therapy with Boceprevir yields higher sustained virologic response (SVR) rates for patients with hepatitis C virus (HCV) genotype 1 who did not respond to or relapsed after treatment with peginterferon alpha 2b and Ribavirin.

2 Nov 2010

Drug Trial News

Immunomedics product candidates, technologies receive recognition from QTDP program

Avila presents results of AVL-192 preclinical studies for HCV infection at AASLD Meeting

Enzon receives $1.2 million in funding under IRS Qualifying Therapeutic Discovery Project program

ImmunoGen to present clinical data of lead compounds at EORTC-NCI-AACR Symposium

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

BioCancell reports results of BC-819 Phase I/IIa clinical trial for pancreatic cancer

Bristol-Myers extends time to review BLA for ipilimumab in melanoma

NeurogesX initiates NGX-1998 Phase 2 study in postherpetic neuralgia

CytRx receives nontaxable grant under Qualifying Therapeutic Discovery Project Program

Nile announces results of CD-NP Phase 2 study in renally compromised ADHF patients

Combining telaprevir regimen with standard therapy improves SVR rate in hepatitis C

Asthmatx presents 2-year results from AIR2 Trial of bronchial thermoplasty in severe asthma

NPS third quarter net loss increases to $15.7 million

RegeneRx announces positive results from RGN-259 non-clinical study for Dry Eye Syndrome

Inhibitex to present INX-189 data for HCV infections at AASLD Meeting

TriRima shows positive result in food-induced cardiovascular effects associated with MAO inhibitors

Soligenix completes enrollment in RiVax Phase 1B ricin toxin clinical trial

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

ADVANCE Phase 3 study confirms clinical benefits of telaprevir regimen in patients with HCV infection

Boceprevir combinational therapy improves SVR rate in patients with HCV genotype 1

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