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Eli Lilly disagrees with U.S. Court of Appeals ruling on Gemzar method-of-use patent

Eli Lilly and Company today announced that the U.S. Court of Appeals for the Federal Circuit has upheld a prior ruling by the U.S. District Court for the Eastern District of Michigan that Gemzar's method-of-use patent is invalid.

29 Jul 2010

Etubics enters Phase I trials for next generation vector vaccines

Etubics Corporation, a biopharmaceutical company developing next generation vector vaccines, has entered into Phase I trials at Duke University with its ETBX-011, a therapeutic vaccine candidate that is intended to treat Carcinoembryonic Antigen expressing cancers such as colorectal cancer. Etubics dosed its first patient yesterday. Etubics was recently granted clearance by the U.S. Food and Drug Administration for its Investigational New Drug application to begin studying ETBX-011 in humans.

29 Jul 2010

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Chimerix, Inc., a biopharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of research results demonstrating the potential of CMX157 (hexadecyloxypropyl tenofovir) to effectively suppress replication of human immunodeficiency virus (HIV) that cannot be treated with currently available nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), including tenofovir disoproxil fumarate (Viread), due to the development of multi-drug resistance. Earlier this year, Chimerix initiated a dose-escalating Phase 1 clinical trial of CMX-157 to evaluate drug safety, tolerability and pharmacokinetics.

29 Jul 2010

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the second quarter and six months ended June 30, 2010. For the second quarter, AMAG reported total revenue of $18.8 million, including $16.0 million of Feraheme® (ferumoxytol) Injection for intravenous (IV) use net product revenues.

29 Jul 2010

Intercept signs CRADA with NIDDK for study of obeticholic acid in nonalcoholic steatohepatitis

Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for chronic fibrotic and metabolic diseases, today announced the signing of a cooperative research and development agreement (CRADA) with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health to conduct a double blind, multi-center, study to evaluate the effects of obeticholic acid in patients with nonalcoholic steatohepatitis (NASH).

28 Jul 2010

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

Pain Therapeutics, Inc., a biopharmaceutical company, today reported second quarter financial results. Net loss for the quarter ended June 30, 2010 was $0.8 million, or $0.02 per share, compared to net loss of $34,000, or $0.00 per share, for the second quarter of 2009. Pain Therapeutics had cash, cash equivalents and marketable securities of $176.2 million, or about $4.14 cash per share, and no debt as of June 30, 2010.

28 Jul 2010

SurModics, EGEN continue collaboration on long-term controlled release of siRNA complexes

SurModics, Inc., a leading provider of drug delivery and surface modification technologies to the healthcare industry and EGEN, Inc., a privately held biopharmaceutical company focused on developing nucleic acid (DNA and RNAi) therapeutics for the treatment of human diseases, are pleased to announce they have executed a continuation of their feasibility collaboration focused on long-term controlled release of siRNA complexes.

28 Jul 2010

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that it has enrolled the first patient in its Phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery.

27 Jul 2010

Advanced Life Sciences enters agreement with UBC to develop antimicrobial peptides

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has entered into a sponsored research and option agreement with The University of British Columbia (UBC) to develop several antimicrobial peptides.

27 Jul 2010

ProtAffin signs manufacturing contract with CMC Biologics for COPD drug PA401

ProtAffin AG, a biotechnology company developing a novel class of biopharmaceutical products that act by targeting cell-surface glycan structures, today announced it has signed a manufacturing contract with CMC Biologics' Danish operations, located in Copenhagen, Denmark for manufacture of its lead product PA401 for the treatment of chronic obstructive pulmonary disease (COPD). The contract will cover manufacture and supply of PA401 for preclinical development and early clinical development in COPD and related respiratory indications.

27 Jul 2010

Pilot program to confront major eDiscovery challenges in life sciences

eDiscovery for Pharma, Biotech and Medical Device Industries will be the key meeting of the year for eDiscovery experts in the life science space. This event will bring together leading eDiscovery experts to confront the major eDiscovery challenges specific to pharmaceutical, biotech, and medical device industries.Attendees will learn best eDiscovery practices to help prepare organizations for FDA inquiries, patent litigation, HIPAA compliance and data security issues; plus CLE credits are available.

27 Jul 2010

Study on interactions between new antitubercular drug candidates SQ109 and TMC207

Sequella, Inc., a clinical-stage biopharmaceutical company developing drugs for treatment of life-threatening infectious diseases, announced today the publication of studies in the scientific journal Antimicrobial Agents and Chemotherapy on synergy between SQ109, its lead drug candidate for the treatment of TB, and TMC207, Tibotec lead TB drug candidate:

27 Jul 2010

Idenix second-quarter total revenues decrease to $1.3 million

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2010. At June 30, 2010, Idenix's cash and cash equivalents totaled $51.0 million.

27 Jul 2010

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and other metabolic diseases, and Groupe Novasep (Novasep), a leading supplier of manufacturing solutions to the life sciences industries, announce today that they have received French Government funding through OSEO to finance the development of CER-001, a Cerenis HDL mimetic.

26 Jul 2010

Cerenis Therapeutics closes first round of series C, raises €40 million

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company specializing in the research and development of novel therapies based on the metabolism of HDL (the "good" cholesterol) to treat cardiovascular and other metabolic diseases, announced today it has raised €40 million in the first close of its series C financing. In this round €20 million came from the Fund for Strategic Investment (FSI) with an additional €20 million coming from the existing investors: Sofinnova Partners, HealthCap, Alta Partners and TVM Capital, EDF Ventures, OrbiMed and DAIWA Corporate Investment.

26 Jul 2010

Sartorius reports substantial gain in first half for 2010

Today Sartorius, a leading international process and laboratory technology provider, published its first-half results for 2010. Both the Biotechnology Division and the Mechatronics Division reported substantial gains in order intake and sales revenue. The two divisions expanded their business in all regions. Besides the continued strong development in the Biotechnology Division, the positive earnings contributed by the Mechatronics Division are especially encouraging, given that this division faced an exceptionally adverse business climate last year as a result of the global economic crisis.

From Sartorius 26 Jul 2010

L2FU reports 100% recovery of recent study's lost clinical trial patients

Recovering unnecessarily lost patient information is now a viable reality. Lost to follow up rates in clinical research trials can range from 20- 60%. As a result, patients who drop from a clinical trial and 'go missing' can impart a major set-back in pharmaceutical research. Failure to contact patients and obtain final closure data, or bring them back into the clinical trial (if the protocol allows) results in study delays, increased patient recruitment costs, compromised study data, and in some cases an insufficient amount of information to prove the safety and efficacy of a drug.

26 Jul 2010

Advanced Life Sciences enters debt for equity exchange agreement with CEO

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has entered into a debt for equity exchange agreement with its chairman and CEO Michael T. Flavin, Ph.D.

23 Jul 2010

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that a 44-year-old female patient with advanced acute promyelocytic leukemia (APL) achieved molecular complete remission with no evidence of disease in the blood cells and/or bone marrow following treatment with CytRx's oncology drug candidate tamibarotene.

23 Jul 2010

BioStata invests in KIKA's Veracity advanced EDC platform

KIKA™ Clinical Solutions, the leader in advanced EDC solutions for Clinical Asset Management™, announced that Denmark-based CRO BioStata ApS has made a seven-figure investment in KIKA technology to provide its Veracity™ advanced EDC platform to biopharmaceutical clients in Europe.

21 Jul 2010

Biopharmaceutical News and Research

Eli Lilly disagrees with U.S. Court of Appeals ruling on Gemzar method-of-use patent

Etubics enters Phase I trials for next generation vector vaccines

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

Intercept signs CRADA with NIDDK for study of obeticholic acid in nonalcoholic steatohepatitis

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

SurModics, EGEN continue collaboration on long-term controlled release of siRNA complexes

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Advanced Life Sciences enters agreement with UBC to develop antimicrobial peptides

ProtAffin signs manufacturing contract with CMC Biologics for COPD drug PA401

Pilot program to confront major eDiscovery challenges in life sciences

Study on interactions between new antitubercular drug candidates SQ109 and TMC207

Idenix second-quarter total revenues decrease to $1.3 million

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

Cerenis Therapeutics closes first round of series C, raises €40 million

Sartorius reports substantial gain in first half for 2010

L2FU reports 100% recovery of recent study's lost clinical trial patients

Advanced Life Sciences enters debt for equity exchange agreement with CEO

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

BioStata invests in KIKA's Veracity advanced EDC platform

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