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AlphaRx reports positive preclinical results of GAI-122 injectable nanoemulsion for Acute Ischemic Stroke

AlphaRx, Inc. announced positive preclinical results of GAI-122 injectable nanoemulsion, a Mitochondria-targeted neuroprotective drug candidate being developed for the treatment of Acute Ischemic Stroke. The results will be delivered as a podium presentation during the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon July 10 - 14, 2010.

13 Jul 2010

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Biodel Inc. today reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus® (insulin glargine).

13 Jul 2010

BioSpecifics' partner Auxilium provides update on XIAFLEX

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that its strategic partner Auxilium Pharmaceuticals, Inc. has provided an update on XIAFLEX, its injectable collagenase product currently marketed in the U.S. for the treatment of Dupuytren's contracture.

13 Jul 2010

Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

Hemispherx Biopharma, Inc., announced that it has received a report, prepared by Hideki Hasegawa, M.D. Ph.D., Director, Laboratory of Infectious Disease Pathology, National Institute of Infectious Disease, that summarizes the results of a three year Japanese government funded program to develop and test a nasally delivered H5N1 (Avian Flu) vaccine which, when coupled with Ampligen®, an experimental therapeutic, provided a robust and long lasting immune response to the vaccine.

12 Jul 2010

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Novelos Therapeutics, Inc., a biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today announced 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, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

12 Jul 2010

Reata funds second pivotal trial of bardoxolone with $78 million equity financing

Reata Pharmaceuticals, Inc. has completed a $78 million equity financing led by existing investors CPMG, Inc. and Novo A/S. This financing brings the total raised by the Company to $180 million since inception.

12 Jul 2010

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Medivir announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).

12 Jul 2010

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

KAEL-GemVax, a leading oncology vaccine company, today announced, through its subsidiary GemVax A.S, encouraging interim progress from the UK-based Phase III TeloVac study of its anti-telomerase therapeutic cancer vaccine GV1001 in pancreatic cancer. The company also strongly believes GV1001 has major "blockbuster" potential as a universal therapeutic cancer vaccine and is developing a strong pipeline for other indications, including lung and liver cancer and melanoma.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum AB today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

12 Jul 2010

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

bitop AG, a biotech company specializing in the development of Ectoin®-containing medical devices, reports that Ectoin allergy nasal spray has been shown to significantly reduce symptoms of acute allergic rhinitis in a two-week observational, randomized, comparative crossover study with 50 patients suffering from acute allergic rhinitis. Based on this study, bitop performed a clinical trial on eyes drops and nasal spray in humans using an environmental exposure chamber (EEC) model.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

AmpliMed Corporation, a cancer therapeutics company, today announced results from AMP-019, a randomized double-blind, placebo-controlled Phase II screening trial designed to determine if a Phase III trial was warranted for the combination of gemcitabine (Gemzar, Eli Lilly) plus Amplimexon (AmpliMed Corporation) in patients with advanced pancreatic ductal adenocarcinoma of the pancreas.

12 Jul 2010

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Australian regenerative medicine company, Mesoblast Limited, today announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration to discuss a proposed Phase 3 clinical trial program.

12 Jul 2010

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Results from a Phase III program evaluating imiquimod 3.75% and 2.5% creams for the treatment of EGW, applied once daily for up to 8 weeks, demonstrated that both were well-tolerated and more efficacious than placebo, according to data presented at the annual Human Papillomavirus Conference in Montreal, July 3 - 8. Investigators found that efficacy was greatest for imiquimod 3.75% with an enhanced safety profile.

9 Jul 2010

Phase II trial results of TB-402 presented at International Congress on Thrombosis

BioInvent International AB and ThromboGenics NV announce that the positive results from a Phase II trial of TB-402 (Anti-Factor VIII antibody) were presented at the 21st International Congress on Thrombosis in Milan, Italy yesterday. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism following orthopaedic surgery.

9 Jul 2010

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Phase I clinical data for BAY86-6150, a novel recombinant factor VIIa protein (rFVIIa) being developed by Bayer HealthCare, will be presented at the XXIX International Congress of the World Federation of Hemophilia (WFH) to be held in Buenos Aires, Argentina from Saturday, July 10-Wednesday, July 14.

9 Jul 2010

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate, a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.

8 Jul 2010

Advanced Life Sciences announces positive results from preclinical studies of Restanza IV

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 positive results from preclinical toxicology and pharmacokinetic studies of an intravenous (IV) formulation of its novel antibiotic, Restanza™ that support its use in a hospital setting.

8 Jul 2010

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR™ in the United States. Kiadis Pharma is currently enrolling patients in a multinational, pivotal clinical study at hospitals in Europe and Canada. With the approval of the IND, US hospitals will also participate in this study.

8 Jul 2010

Selvita, Orion collaborate to develop and commercialize SEL103 Alzheimer’s disease program

Selvita sp. z o.o., from Krakow, Poland and Orion Corporation from Espoo, Finland (ORNBV) today announced that they have entered into a global collaboration to jointly develop and commercialize SEL103, Selvita's proprietary program for the treatment of Alzheimer's disease and other cognitive disorders. Selvita will be responsible for early research on the program and Orion will take over the pre-clinical and clinical development as well as further commercialization.

8 Jul 2010

Drug Trial News

AlphaRx reports positive preclinical results of GAI-122 injectable nanoemulsion for Acute Ischemic Stroke

Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

BioSpecifics' partner Auxilium provides update on XIAFLEX

Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Reata funds second pivotal trial of bardoxolone with $78 million equity financing

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Phase II trial results of TB-402 presented at International Congress on Thrombosis

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Advanced Life Sciences announces positive results from preclinical studies of Restanza IV

Kiadis Pharma receives FDA approval for IND to start pivotal clinical study for ATIR

Selvita, Orion collaborate to develop and commercialize SEL103 Alzheimer’s disease program

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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