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Merck's initiation of IMO-2055 Phase 1b clinical trial in SCCHN triggers €3.0M milestone payment to Idera

Idera Pharmaceuticals, Inc., today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon Merck KGaA's initiation of a Phase 1b clinical trial of IMO-2055 (EMD 1201081), an agonist of Toll-like Receptor 9 (TLR9), in combination with cisplatin, fluorouracil and cetuximab (Erbitux®) in first-line treatment of patients with squamous cell carcinoma of the head and neck (SCCHN).

27 Aug 2010

Experimental drug PLX4032 holds promise against cancers with faulty BRAF gene

An experimental drug designed to treat cancers with a particular genetic fault has shown promising results in a small clinical trial.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

Vanda Pharmaceuticals initiates tasimelteon Phase III clinical trial for Non-24-Hour Sleep Wake Disorder

Vanda Pharmaceuticals Inc., today announced it has initiated a Phase III clinical trial to evaluate tasimelteon in patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness.

26 Aug 2010

Lotus Pharmaceuticals initiates R-Bambuterol Clinical Trial I on-schedule

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China, announced today that it has entered R-Bambuterol Clinical Trial I on-schedule and is on-track to complete in six months. The studies will evaluate the safety and tolerability of the new drug as well as the biological activity by measuring responses in healthy volunteers.

26 Aug 2010

NeoPharm second-quarter net loss decreases to $0.8 million

NeoPharm, Inc., a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for various forms of cancer and other diseases, today announced its second quarter 2010 financial results.

26 Aug 2010

Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, today announced that it has initiated a dose-defining Phase IIa trial of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure.

26 Aug 2010

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency.

26 Aug 2010

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Plexxikon today announced publication of data from the Phase 1 clinical trial of PLX4032 (RG7204), confirming that treatment of metastatic melanoma patients with the BRAF V600E mutation resulted in significant tumor shrinkage in the majority of patients. Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81 percent of patients had tumor shrinkage of at least 30 percent.

26 Aug 2010

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced that results of a Phase 1 clinical study of CRLX101 (formerly IT-101), Cerulean's lead clinical development candidate, and pre-clinical data on Cerulean's development candidate, CRLX288, were presented at the American Chemical Society National Meeting & Exposition, ongoing in Boston, Massachusetts.

26 Aug 2010

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.

26 Aug 2010

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management.

26 Aug 2010

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Nabi Biopharmaceuticals announced the receipt of a patent for treating and preventing nicotine addiction with NicVAX® and related nicotine conjugate vaccines. The United States Patent and Trademark office issued U.S. Patent No. 7,776,620 entitled "Hapten-carrier conjugates for treating and preventing nicotine addiction" for the exclusive use of methods for treating and preventing nicotine addiction with NicVAX and related nicotine vaccines. This patent runs through December 2018.

26 Aug 2010

Afferent Pharmaceuticals' P2X3 receptor antagonist reduces bladder hyperactivity

Afferent Pharmaceuticals, a clinical-stage biopharmaceutical company developing first-in-class, small molecule compounds that target P2X3 receptors, today announced preclinical in vivo results demonstrating that an investigational P2X3 receptor antagonist reduced experimentally induced bladder hyperactivity.

26 Aug 2010

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

CHX Technologies Inc., a private Canadian pharmaceutical company that is developing new treatments for the prevention of dental diseases, today announced successful results in its final controlled pivotal trial of Prevora, its proprietary antibacterial tooth coating for the prevention of cavities. The trial surpassed objectives set by the Food and Drug Administration (FDA) protocol, clearing the way for CHX to start the process of seeking FDA approval for use in the United States.

25 Aug 2010

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

ImmuneRegen BioSciences®, a wholly owned subsidiary of IR Biosciences Holdings Inc., today announced that the National Institute of Health/National Institute of Allergy and Infectious Disease, has awarded its research partner, the University of Rochester Medical Center (URMC), a $15 million five-year, continuation grant for studies that will utilize ImmuneRegen's Homspera.

25 Aug 2010

Preliminary results from Phase 3 AVERROES trial in atrial fibrillation to be presented at cardiology congress 2010

Bristol-Myers Squibb Company and Pfizer report that preliminary results from the Phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010. The results will be presented during the "Hot Line" session on August 31, 2010, in Stockholm, Sweden.

25 Aug 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

ZymoGenetics, Inc. today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection.

25 Aug 2010

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine, Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present ulimorelin Phase 2 data at this year's Joint International NGM Meeting on Saturday, August 28, 2010.

25 Aug 2010

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the United States and European Union, respectively. The findings were highly statistically significant in 4 mg and 8 mg doses compared to placebo.

25 Aug 2010

Drug Trial News

Merck's initiation of IMO-2055 Phase 1b clinical trial in SCCHN triggers €3.0M milestone payment to Idera

Experimental drug PLX4032 holds promise against cancers with faulty BRAF gene

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

Vanda Pharmaceuticals initiates tasimelteon Phase III clinical trial for Non-24-Hour Sleep Wake Disorder

Lotus Pharmaceuticals initiates R-Bambuterol Clinical Trial I on-schedule

NeoPharm second-quarter net loss decreases to $0.8 million

Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Afferent Pharmaceuticals' P2X3 receptor antagonist reduces bladder hyperactivity

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

Preliminary results from Phase 3 AVERROES trial in atrial fibrillation to be presented at cardiology congress 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

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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