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Study finds antibiotic safe for treatment of stroke and good companion therapy for tPA

An antibiotic appears to be a safe treatment for stroke and a good companion therapy for tPA, the clot buster that is currently the only FDA-approved drug therapy, researchers report.

13 Sep 2010

Provectus's PV-10 Phase 2 data to be presented at 7th International Melanoma Research Congress

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announces that data from its Phase 2 PV-10 metastatic melanoma study will be presented at the 7th International Melanoma Research Congress in Sydney, Australia, on November 4, 2010 at 4:30 p.m., as part of the 4th Interdisciplinary Melanoma & Skin Cancer Centres Meeting,

13 Sep 2010

Relypsa completes $70M Series B financing

Relypsa, Inc., a biopharmaceutical company developing non-absorbed polymeric drugs, today announced the completion of a Series B financing totaling $70 million. OrbiMed Advisors, LLC, led the financing with participation from existing Relypsa investors New Leaf Venture Partners, 5AM Ventures, Delphi Ventures, Sprout Group and Mediphase Venture Partners.

13 Sep 2010

FDA updates Shire's ProAmatine medicine for symptomatic orthostatic hypotension treatment

Shire, the global specialty biopharmaceutical company, announces that the United States Food and Drug Administration today posted an update on its website related to ProAmatine (known generically as midodrine), a medicine approved for the treatment of symptomatic orthostatic hypotension.

13 Sep 2010

Jennerex reports positive interim data from trial of JX-594 and sorafenib for liver cancer

Jennerex, Inc., a clinical-stage biotherapeutics company focused on the development of first-in-class, targeted oncolytic products for cancer, today reported positive interim data from a pilot trial using JX-594 followed by sorafenib (Nexavar®) to treat liver cancer patients. The data were presented today at the Fourth Annual International Liver Cancer Association Conference in Montreal, Canada.

13 Sep 2010

AB SCIEX, University of Melbourne join to develop drug metabolism studies of biopharmaceuticals

AB SCIEX, a global leader in life science analytical technologies, and the University of Melbourne today announced a joint technology development project to improve drug metabolism studies of biopharmaceuticals.

13 Sep 2010

Tetraphase Pharmaceuticals presents TP-434 drug candidate clinical data

Tetraphase Pharmaceuticals, Inc., yesterday presented new clinical and preclinical data for its lead drug candidate, TP-434, which demonstrated the novel antibiotic as a once daily intravenous (I.V.) monotherapy capable of treating multidrug-resistant gram-negative pathogens while also having potency and broad spectrum coverage of other serious and multidrug resistant gram-positive pathogens.

13 Sep 2010

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Incyte Corporation announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).

13 Sep 2010

XenoPort intends to initiate Phase 3 XP19986 trial for multiple sclerosis

XenoPort, Inc. announced today that it plans to move arbaclofen placarbil (AP), also known as XP19986, into Phase 3 development as a potential treatment of spasticity in multiple sclerosis (MS) patients.

13 Sep 2010

Vical's TransVax CMV vaccine achieves key endpoints in Phase 2 trial in immunocompromised HCT recipients

Vical Incorporated announced today the achievement of key efficacy, immunogenicity and safety results in a Phase 2 trial, establishing its TransVax™ cytomegalovirus (CMV) vaccine as the first to provide evidence of protection in immunocompromised hematopoietic cell transplant (HCT) recipients, and defining a potential pathway for further development.

13 Sep 2010

Inovio Pharmaceuticals achieves promising results in VGX-3100 Phase I study

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has achieved best-in-class immune responses in its Phase I dose escalation study of VGX-3100, its DNA vaccine to treat pre-cancerous cervical dysplasias and cervical cancers caused by human papillomavirus (HPV) types 16 and 18.

13 Sep 2010

Researchers develop KU-32 drug to prevent diabetic peripheral neuropathy

A drug developed at the University of Kansas has the potential to stop a debilitating condition of diabetes that often leads to pain in the extremities and even amputations, KU researchers have found.

13 Sep 2010

FDA approves CorMatrix ECM for Pericardial Closure

CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.

13 Sep 2010

NanoBio Corporation to present Nanoemulsion Phase I clinical trial data at ICAAC Conference

NanoBio Corporation today announced it will present data from two separate Phase 1 clinical trials at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), taking place in Boston, Mass. from Sept. 12-15.

13 Sep 2010

Genmab announces Phase II ofatumumab study results in RRMS patients

Genmab A/S announced today encouraging results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS).

13 Sep 2010

More men than women discontinue medications due to side effects

Men are more likely than women to discontinue a medication due to side effects. More and more men are diagnosed with age-related issues like enlarged prostate and men are being prescribed medications that have side effects. These side effects often cause men to say "NO." In the U.S. and Canada, Prostate prescriptions dominate the treatment of enlarged prostate.

10 Sep 2010

Instem announces Centrus Solution Suite for enterprise information integration in early drug development

Instem, a leading provider of early drug development software solutions, announced today details of their newest product line, Centrus™, for enterprise information integration in early drug development. Centrus provides a single, secure environment to access, harmonize and use early drug development information from a variety of sources, including current data acquisition systems, legacy systems, warehouses, partner and contract research applications, to meet the rapidly-expanding needs of life science organizations for data-driven decision making.

10 Sep 2010

Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., today announced that it has unblinded the Phase 3 study of abiraterone acetate plus prednisone for the treatment of patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer) whose disease has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel.

10 Sep 2010

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors

We applaud the U.S. Food and Drug Administration for taking appropriate enforcement action today against five distributors of electronic cigarettes for various violations of the Federal Food, Drug and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices.

10 Sep 2010

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010

Efficacy News and Research

Study finds antibiotic safe for treatment of stroke and good companion therapy for tPA

Provectus's PV-10 Phase 2 data to be presented at 7th International Melanoma Research Congress

Relypsa completes $70M Series B financing

FDA updates Shire's ProAmatine medicine for symptomatic orthostatic hypotension treatment

Jennerex reports positive interim data from trial of JX-594 and sorafenib for liver cancer

AB SCIEX, University of Melbourne join to develop drug metabolism studies of biopharmaceuticals

Tetraphase Pharmaceuticals presents TP-434 drug candidate clinical data

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

XenoPort intends to initiate Phase 3 XP19986 trial for multiple sclerosis

Vical's TransVax CMV vaccine achieves key endpoints in Phase 2 trial in immunocompromised HCT recipients

Inovio Pharmaceuticals achieves promising results in VGX-3100 Phase I study

Researchers develop KU-32 drug to prevent diabetic peripheral neuropathy

FDA approves CorMatrix ECM for Pericardial Closure

NanoBio Corporation to present Nanoemulsion Phase I clinical trial data at ICAAC Conference

Genmab announces Phase II ofatumumab study results in RRMS patients

More men than women discontinue medications due to side effects

Instem announces Centrus Solution Suite for enterprise information integration in early drug development

Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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