Pharmaceuticals News and Research

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Syndax reports promising results from entinostat preclinical studies in breast cancer

Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announces results from two preclinical studies on entinostat, an orally bioavailable, highly selective, class I histone deacetylase (HDAC) inhibitor, in animal models of breast cancer. The data are being presented as oral poster discussions at the San Antonio Breast Cancer Symposium December 8 through December 12 in San Antonio Texas.

13 Dec 2010

Research programs embody the promise of anti-aging medicine.

Sometimes the value of research lies as much in exposing false remedies as in discovering true breakthroughs. Scientists at the country's first school of gerontology and in laboratories around the University of Southern California do both, mindful of their responsibility to a society focused on healthful aging.

13 Dec 2010

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Boehringer Ingelheim Pharmaceuticals, Inc. announced that new data from a subgroup analysis of the phase IIb/III LUX-Lung 1 trial show that afatinib (BIBW 2992) reached a four-fold extension (4.4 months vs. 1.0 month for placebo) in progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients most likely to have an epidermal growth factor receptor (EGFR) mutation. The updated LUX-Lung 1 data will be presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

13 Dec 2010

Novelos NOV-002 demonstrates positive results in Phase 2 neoadjuvant breast cancer trial

Novelos Therapeutics, Inc., a biopharmaceutical company developing therapeutics to treat cancer, announced that today a poster highlighting positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer is being presented by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine at the AACR Breast Cancer Symposium in San Antonio, TX.

13 Dec 2010

Access announces $6.0 million registered direct offering

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, has entered into definitive agreements with existing and new accredited investors to sell, in a registered direct offering, an aggregate of approximately 2.3 million shares of its common stock at a price of $2.55 per share for aggregate gross proceeds of $6.0 million.

10 Dec 2010

Positive preliminary results from tivozanib-paclitaxel combination Phase 1b trial in metastatic breast cancer

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced preliminary results from an ongoing Phase 1b clinical trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with paclitaxel (Taxol®), a standard chemotherapy regimen, in patients with metastatic breast cancer.

10 Dec 2010

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

Arena Pharmaceuticals, Inc. announced today the initiation of dosing in a Phase 1 clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin receptor for the treatment of pulmonary arterial hypertension, or PAH.

10 Dec 2010

FDA approves Mylan's generic Adalat CC Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Bayer's Adalat® CC Tablets, a treatment for hypertension.

10 Dec 2010

PLD/carboplatin to replace paclitaxel/carboplatin as gold-standard treatment for platinum-sensitive ovarian cancer

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that although platinum-based treatment will continue to be the standard of care for first- and second-line treatment of platinum-sensitive ovarian cancer, pegylated liposomal doxorubicin (PLD)/carboplatin will replace paclitaxel/carboplatin as the standard second-line treatment for patients who remain platinum sensitive.

10 Dec 2010

Pisgah's technology imparts abuse deterrence to commonly abused prescription drugs

Pisgah Labs announced today the findings from a proof of concept study confirming Pisgah's technology imparts abuse deterrence to commonly abused prescription drugs, particularly narcotics. The controlled study, conducted in dogs, was performed with the un-formulated active ingredient, hydrocodone, as modified according to a host of patent applications filed by Pisgah Labs with the United States Patent and Trademark Office (http://www.uspto.gov).

10 Dec 2010

Serodus licenses selective serotonin-4 antagonist for potential heart failure treatment from Roche

Serodus AS today announced that it has entered into a license agreement with Roche for a selective serotonin-4 (5-HT4) antagonist for the potential treatment of heart failure (RO1160367).

10 Dec 2010

Spherix Phase 2 diabetes clinical trial determines minimum D-tagatose dose capable of reducing HbA1c

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its Phase 2 diabetes clinical trial, designed to determine the minimum dose of D-tagatose capable of reducing HbA1c, found that the minimum dose capable of affecting HbA1c (7.5 g three-times daily, or TID) was within the range of doses tested

10 Dec 2010

Everolimus plus tamoxifen delays disease progression in HR+/HER2- metastatic breast cancer

A new study shows that the addition of everolimus (Afinitor® tablets) to the hormonal therapy tamoxifen in patients with hormone-receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who have been previously treated with an aromatase inhibitor (AI) delays disease progression compared to tamoxifen alone. These results were presented today at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium in San Antonio, Texas.

10 Dec 2010

Accovion establishes two additional subsidiaries in the Czech Republic and in Russia

Accovion is a premier full service European CRO known for its expertise in managing and conducting international clinical trials. Accovion supports local and global projects of all types and phases for the pharmaceutical, biotechnology and medical device industries. Its services include study planning and management, clinical monitoring, pharmacovigilance including post-marketing safety, data management, biostatistics, statistical programming, medical writing and electronic publishing.

10 Dec 2010

Prometheus, UCLA collaborate to identify biological markers of mucosal healing in IBD

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, and The Regents of the University of California, Los Angeles campus, today announced the execution of an exclusive research agreement that will focus on the identification of biological markers of mucosal healing in patients with Inflammatory Bowel Disease (IBD). The research will be led by Dr. Jonathan Braun, Chair of the Department of Pathology and Laboratory Medicine and a professor of molecular and medical pharmacology, UCLA David Geffen School of Medicine.

10 Dec 2010

Entinostat plus erlotinib improves survival in NSCLC patients with elevated E-cadherin

Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announces clinical results from ENCORE 401, a double-blind, placebo-controlled phase 2 trial, in patients with advanced non-small cell lung cancer (NSCLC). The results show that there was a survival advantage in the subset of patients with elevated E-cadherin (a molecular marker of epithelial tumors) receiving entinostat in combination with erlotinib (Tarceva®).

10 Dec 2010

Horizon Discovery licenses new human isogenic cell models from Case Western Reserve

With the goal of developing new, more effective and personalized cancer treatments, Horizon Discovery, based in Cambridge, England, has secured from Case Western Reserve University exclusive rights to a panel of new human isogenic cell models developed by the laboratory of Zhenghe Wang, assistant professor of genetics at the university's School of Medicine.

10 Dec 2010

Three-day meeting on eliminating river blindness kicks off in Nigeria

A three-day meeting of the WHO African Program for Onchocerciasis (River blindness) Control (WHO/APOC) opened in Abuja, Nigeria, on Tuesday, PANA/Afrique en ligne reports (12/8).

10 Dec 2010

Celulas Genetica to submit international patent application for Rutherford Procedure

Emerging Healthcare Solutions, Inc. announced today that its newly acquired biotechnology division Celulas Genetica will submit an international patent application for the Rutherford Procedure, a revolutionary new stem-cell treatment for liver disease.

10 Dec 2010

Caliper to acquire CRi for $20.0 million

Caliper Life Sciences, Inc., a leading provider of products and services for drug discovery research, today announced that it has entered into a definitive agreement to acquire privately-held Cambridge Research & Instrumentation, Inc. (CRi) for approximately $20.0 million, including net debt. CRi's patented preclinical and tissue-based multiplexed analysis systems will expand Caliper's life sciences tools portfolio, particularly as it bridges into clinical research, pathology and clinical market applications.

10 Dec 2010

Pharmaceuticals News and Research

Syndax reports promising results from entinostat preclinical studies in breast cancer

Research programs embody the promise of anti-aging medicine.

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Novelos NOV-002 demonstrates positive results in Phase 2 neoadjuvant breast cancer trial

Access announces $6.0 million registered direct offering

Positive preliminary results from tivozanib-paclitaxel combination Phase 1b trial in metastatic breast cancer

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

FDA approves Mylan's generic Adalat CC Tablets ANDA

PLD/carboplatin to replace paclitaxel/carboplatin as gold-standard treatment for platinum-sensitive ovarian cancer

Pisgah's technology imparts abuse deterrence to commonly abused prescription drugs

Serodus licenses selective serotonin-4 antagonist for potential heart failure treatment from Roche

Spherix Phase 2 diabetes clinical trial determines minimum D-tagatose dose capable of reducing HbA1c

Everolimus plus tamoxifen delays disease progression in HR+/HER2- metastatic breast cancer

Accovion establishes two additional subsidiaries in the Czech Republic and in Russia

Prometheus, UCLA collaborate to identify biological markers of mucosal healing in IBD

Entinostat plus erlotinib improves survival in NSCLC patients with elevated E-cadherin

Horizon Discovery licenses new human isogenic cell models from Case Western Reserve

Three-day meeting on eliminating river blindness kicks off in Nigeria

Celulas Genetica to submit international patent application for Rutherford Procedure

Caliper to acquire CRi for $20.0 million

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