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Agendia to participate in groundbreaking clinical trial for breast cancer

Agendia, a world leader in molecular cancer diagnostics, announced today it will participate in the highly anticipated I-SPY 2 TRIAL for breast cancer, set to launch at the first of nearly twenty research sites.

18 Mar 2010

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CPEX Pharmaceuticals Inc. today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with basal insulin and oral anti-diabetes agents.

18 Mar 2010

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

Nabi Biopharmaceuticals announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol.

17 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Alkermes, Inc. today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in approximately 24 healthy volunteers.

17 Mar 2010

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Zogenix, Inc., a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.

17 Mar 2010

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were presented today at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Tel Aviv, Israel.

17 Mar 2010

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD).

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Protalix BioTherapeutics, Inc. announced today that it has initiated a phase I clinical trial of PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase product candidate in development for biodefense indications. The trial is designed to study the safety of PRX-105 by administering a bolus intravenous injection of PRX-105 in healthy volunteers.

17 Mar 2010

Human Genome Sciences announces Phase 2 results of mapatumumab combination therapy for NSCLC

Human Genome Sciences, Inc. today announced the results of its randomized Phase 2 trial of mapatumumab (HGS-ETR1) in combination with the chemotherapy agents paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC).

17 Mar 2010

TRITON-TIMI 38 study evaluates response rates in patients with common genetic variant in ABCB1 gene

A new analysis of the TRITON-TIMI 38 study evaluated response rates in patients with a common genetic variant in the ABCB1 gene. Patients enrolled in the TRITON-TIMI 38 study were treated with dual antiplatelet therapy with either Plavix® (clopidogrel) plus aspirin or Effient® (prasugrel) plus aspirin and managed with percutaneous coronary intervention (PCI) following an acute coronary syndrome (ACS) event.

17 Mar 2010

Human Genome Sciences to deploy Aegis Analytical's Discoverant manufacturing intelligence solution

Aegis Analytical Corp., the leading provider of Enterprise Manufacturing Intelligence software, announced today that Human Genome Sciences, Inc. will deploy Aegis’ Discoverant® as its data management, analytics and reporting solution in the scale-up and production of BENLYSTA™ (belimumab), an investigational drug for the treatment of systemic lupus that has successfully completed Phase 3 trials.

17 Mar 2010

Booster shot appears to improve TB resistance in previously vaccinated adults

A booster shot appears to improve tuberculosis (TB) resistance in previously vaccinated adults, according to new research in South Africa.

17 Mar 2010

Vertex Pharmaceuticals' telaprevir and VX-222 HCV inhibitor abstracts accepted for presentation at 45th EASL meeting

Vertex Pharmaceuticals Incorporated today announced that multiple abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir and the HCV polymerase inhibitor VX-222 were accepted for presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010.

17 Mar 2010

PCI Biotech completes treatment of third dose group in phase I/II study of Amphinex in cancer patients

PCI Biotech reported today that it has completed the treatment of the third dose group in the phase I/II study of its proprietary photosensitiser Amphinex® used in combination with the cytotoxic agent bleomycin in cancer patients.

16 Mar 2010

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Tolerx, Inc., today announced the publication in Diabetologia, the journal of the European Association for the Study of Diabetes, of the four-year follow-up clinical data from new onset type 1 diabetes (T1DM) patients (age 12-39) who received a single short course of therapy with otelixizumab (ChAglyCD3).

16 Mar 2010

Lantheus Medical Imaging announces preliminary data on flurpiridaz F 18 PET MPI agent

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced preliminary data on flurpiridaz F 18 (formerly known as BMS747158), its novel compound in development as a Positron Emission Tomography (PET) myocardial perfusion imaging (MPI) agent. The study of nine patients compared rest-stress flurpiridaz F 18 PET MPI, with rest-stress technetium-99m (Tc-99m) labeled single photon emission computed tomography (SPECT) for the detection and evaluation of coronary artery disease (CAD).

16 Mar 2010

Iverson Genetic Diagnostics to conduct WARFARIN clinical study

Iverson Genetic Diagnostics, Inc. today announced that they will conduct a WARFARIN clinical study to assess the efficacy of gene-based testing prior to initiating warfarin anticoagulation therapy to reduce the incidence of bleeding and thromboembolic events.

16 Mar 2010

Promedior raises $12M in Series C financing

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat inflammatory and fibrotic diseases, today announced that it has raised $12 million in a Series C financing round. Forbion Capital Partners led the round, with participation from existing investors Morgenthaler Ventures, HealthCare Ventures, Polaris Venture Partners, and Easton Capital. The Series C financing brings the total capital raised by Promedior over the past year to $27 million.

16 Mar 2010

Drug Trial News

Agendia to participate in groundbreaking clinical trial for breast cancer

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

ONGLYZA-metformin combination: FDA accepts NDA for review

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Human Genome Sciences announces Phase 2 results of mapatumumab combination therapy for NSCLC

TRITON-TIMI 38 study evaluates response rates in patients with common genetic variant in ABCB1 gene

Human Genome Sciences to deploy Aegis Analytical's Discoverant manufacturing intelligence solution

Booster shot appears to improve TB resistance in previously vaccinated adults

Vertex Pharmaceuticals' telaprevir and VX-222 HCV inhibitor abstracts accepted for presentation at 45th EASL meeting

PCI Biotech completes treatment of third dose group in phase I/II study of Amphinex in cancer patients

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Lantheus Medical Imaging announces preliminary data on flurpiridaz F 18 PET MPI agent

Iverson Genetic Diagnostics to conduct WARFARIN clinical study

Promedior raises $12M in Series C financing

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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