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Bayer Healthcare Pharmaceuticals commences enrollment in florbetaben Phase III clinical trials

Today at the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Bayer HealthCare Pharmaceuticals Inc. announced the enrollment of the first patient in an international Phase III clinical trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid plaques in the brain, which are a pathological hallmark of Alzheimer's disease.

30 Nov 2009

MagForce Nanotechnologies initiates conformity assessment procedure for its Nano-Cancer therapy

MagForce Nanotechnologies AG has submitted the product file for NanoTherm® to Medcert GmbH, the medical certification and testing company which serves as Notified Body for the certification of medical products. With this step, MagForce has now commenced the conformity assessment procedure for its Nano-Cancer ® therapy.

30 Nov 2009

Eli Lilly's Cymbalta receives FDA approval

The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, announced Eli Lilly and Company (NYSE: LLY).

30 Nov 2009

Micromet to present new results from its blinatumomab study at the ASH meeting

Micromet, Inc., a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced that it will present new results from its clinical studies with blinatumomab at the 51st annual meeting of the American Society of Hematology from December 5-8, 2009 in New Orleans, Louisiana.

30 Nov 2009

Spectrum Pharmaceuticals completes enrollment in apaziquone Phase 3 trial

Spectrum Pharmaceuticals today announced that one of the two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target, having enrolled approximately 800 patients with non-invasive bladder cancer. The second Phase 3 clinical trial of apaziquone is expected to complete enrollment by the end of the year.

30 Nov 2009

Gentium announces financial results for the third quarter ended September 30, 2009

Gentium S.p.A. today reported financial results for the quarter ended September 30, 2009.

30 Nov 2009

Minerva Biotechnologies grants Clarient exclusive commercializing rights to its MUC1 diagnostic test

Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that privately held, Waltham, MA-based Minerva Biotechnologies has granted it the exclusive right to develop and commercialize a test that identifies the MUC1* protein, a biomarker researchers believe may be implicated in the spread of many cancers, including breast cancer.

30 Nov 2009

GE Healthcare concentrates on healthymagination to help patients live longer and healthier

Miniaturized ultrasound. Navigation during interventional procedures. Innovations in sound wave imaging. At RSNA 2009, GE Healthcare is finding better ways to see more. And using that information to do more.

30 Nov 2009

Cell Therapeutics' platinum-based anti-tumor compounds demonstrate stronger anti-tumor potency

Cell Therapeutics, Inc. (CTI) announced today that its new class of platinum-based anti-tumor compounds, termed bis-platinates, demonstrated a stronger anti-tumor potency and activity compared to currently available platinum-based compounds as well as the ability to overcome cisplatin-resistance in cancer cell lines.

30 Nov 2009

Intellivest Securities Research publishes a Report on BioClinica

Intellivest Securities Research, Inc., ("ISR") a Georgia registered investment advisor, has published a Report on BioClinica, Inc. ( BIOC) which serves companies in the pharmaceutical, biotechnology and medical device industries.

30 Nov 2009

Cromoz's new drug delivery system to reduce amount of drugs used in cancer treatment

Cromoz Inc., located in Research Triangle Park, will initiate water-soluble carbon nanotube-based cancer drug delivery system in Hyderabad, India. The water-soluble carbon nanotubes, which have functional groups on the walls that allows for conjugation with cancer drugs, was developed in partnership with the Indian Institute of Kanpur (ITT). The conjugated carbon nanotubes serves as a drug delivery vehicle with the ability to target the cancer site which has the potential to increase the drug efficacy.

28 Nov 2009

MUHC's innovative treatment for HIV patients passes first clinical trial successfully

An innovative treatment for HIV patients developed by McGill University Health Centre researchers has passed its first clinical trial with flying colours. The new approach is an immunotherapy customized for each individual patient, and was developed by Dr. J-P. Routy from the Research Institute of the MUHC in collaboration with Dr. R. S-kaly from the Universit- de Montr-al.

26 Nov 2009

Merck to commence MK-6913 phase IIa efficacy trial for treatment of hot flashes/hot flushes

The Swedish biotech company Karo Bio today announced that Merck & Co., Inc., through an affiliate, plans to enter a clinical phase IIa trial with the collaboration's lead investigational drug candidate, MK-6913, identified as part of their joint research collaboration. No milestone payment to Karo Bio is associated with the initiation of phase II clinical development.

26 Nov 2009

Patients may not benefit from e-samples of prescription drugs, says UW

Search the Internet to learn about your asthma, high cholesterol or other common disorder, and odds are you'll be directed to a pharmaceutical company-sponsored Web homepage. There you'll often find an offer for a free sample or a one-time discount on a top-selling prescription medication.

25 Nov 2009

Tibotec Therapeutics' INTELENCE granted FDA traditional approval

The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents.

25 Nov 2009

Additional data on lubiprostone presented at the GASTRO 2009 UEGF/WCOG meeting

Sucampo Pharma Europe, Ltd., and Sucampo Pharma Americas, Inc., subsidiaries of Sucampo Pharmaceuticals, Inc., today presented additional clinical data for lubiprostone (Amitiza®) at GASTRO 2009 UEGF/WCOG, the joint meeting of the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED) and the British Society of Gastroenterology (BSG), in London.

25 Nov 2009

FDA approves Berinert for treating HAE in adults and adolescents

Berinert®, a human C1 esterase inhibitor (C1-INH) for treating acute episodes of facial or abdominal hereditary angioedema (HAE) in adults and adolescents has obtained approval from the US Food and Drug Administration (FDA).

25 Nov 2009

Synexus recruits patients to study paediatric vaccine against rotavirus

UK-based Synexus, the world’s largest multi-national company dedicated to the recruitment and running of clinical trials, recruited the highest number of patients to the South African study investigating a paediatric vaccine against rotavirus.

From AES - Accelerated Enrollment Solutions 25 Nov 2009

Positive Phase II/III clinical data from ChemoCentryx' PROTECT-1 Traficet-EN trial

ChemoCentryx, Inc., announced today that Phase II/III clinical data from the Company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated clinical efficacy with a favorable safety and tolerability profile. The

25 Nov 2009

CHMP positive opinion for marketing ELONVA in Europe

PROLOR Biotech, Inc., today noted the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for marketing approval in Europe for ELONVA(R), a long-acting CTP-modified version of the fertility hormone FSH from Merck & Co. Merck and PROLOR are both licensees of the CTP technology from Washington University in St. Louis.

25 Nov 2009

Efficacy News and Research

Bayer Healthcare Pharmaceuticals commences enrollment in florbetaben Phase III clinical trials

MagForce Nanotechnologies initiates conformity assessment procedure for its Nano-Cancer therapy

Eli Lilly's Cymbalta receives FDA approval

Micromet to present new results from its blinatumomab study at the ASH meeting

Spectrum Pharmaceuticals completes enrollment in apaziquone Phase 3 trial

Gentium announces financial results for the third quarter ended September 30, 2009

Minerva Biotechnologies grants Clarient exclusive commercializing rights to its MUC1 diagnostic test

GE Healthcare concentrates on healthymagination to help patients live longer and healthier

Cell Therapeutics' platinum-based anti-tumor compounds demonstrate stronger anti-tumor potency

Intellivest Securities Research publishes a Report on BioClinica

Cromoz's new drug delivery system to reduce amount of drugs used in cancer treatment

MUHC's innovative treatment for HIV patients passes first clinical trial successfully

Merck to commence MK-6913 phase IIa efficacy trial for treatment of hot flashes/hot flushes

Patients may not benefit from e-samples of prescription drugs, says UW

Tibotec Therapeutics' INTELENCE granted FDA traditional approval

Additional data on lubiprostone presented at the GASTRO 2009 UEGF/WCOG meeting

FDA approves Berinert for treating HAE in adults and adolescents

Synexus recruits patients to study paediatric vaccine against rotavirus

Positive Phase II/III clinical data from ChemoCentryx' PROTECT-1 Traficet-EN trial

CHMP positive opinion for marketing ELONVA in Europe

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Automating research - solutions and best practices

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