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FDA's BPAC renders positive opinion on Phase III clinical trial of INTERCEPT Blood System

Cerus Corporation announced today that the FDA's Blood Products Advisory Committee (BPAC) rendered a positive opinion on the proposed hemostatic efficacy and safety endpoints for a potential U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets.

17 Nov 2009

Roche receives EUA from FDA for its RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 virus

Roche`s RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The Roche kit detects RNA from the 2009 H1N1 influenza A virus and allows rapid and accurate identification of patients infected with this virus.

17 Nov 2009

ARCA biopharma provides financial and Gencaro NDA update

ARCA biopharma, Inc. today announced its planned next steps in response to the May 29, 2009 Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for ARCA’s New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure. Following receipt of the CRL, the Company and the FDA have held a series of meetings to discuss how best to address the requirements identified in the CRL.

17 Nov 2009

Additional data from Aegerion Pharmaceuticals' ongoing lomitapide Phase III trial

Aegerion Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of cardiovascular and metabolic disease, today announced additional data from its ongoing Phase III trial involving its lead cholesterol management compound, lomitapide (AEGR-733), which is a microsomal triglyceride transfer protein (MTP) inhibitor small molecule drug.

16 Nov 2009

Decision Resources: Neuropathic pain drug market to be $9.7B in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the neuropathic pain drug market -- driven by the launches of several novel therapies -- will increase from $6 billion in 2008 to $9.7 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

16 Nov 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Positive results from Winston Laboratories' Civamide Patch trial

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. today announced positive top-line results from Study WL1001-04-03, a Phase II clinical trial evaluating the safety and efficacy of the company's patch formulation of Civamide, a novel TRPV-1 receptor modulator in the treatment of post-herpetic neuralgia (PHN).

16 Nov 2009

Aradigm commences patient dosage in Phase 2 trial of novel inhaled ciprofloxacin formulation

Aradigm Corporation today announced that the first patient was dosed in a 6-month, multicenter, international Phase 2 clinical trial of a novel version of inhaled ciprofloxacin (ARD-3150) in 40 adult patients with non-cystic fibrosis bronchiectasis.

16 Nov 2009

FDA issues a Complete Response Letter for Human Genome Sciences' raxibacumab BLA

Human Genome Sciences, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.

16 Nov 2009

SANUWAVE Health reports financial results for the three months ended September 30, 2009

SANUWAVE Health, Inc.,, an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, reports its achievements and financial results for the three and nine months ended September 30, 2009.

16 Nov 2009

Personal CGM improves glucose control for diabetes patients

In acknowledgement of this year’s World Diabetes Day, which calls on all those responsible for diabetes care to understand diabetes and take control, Medtronic, Inc. (NYSE: MDT) highlights the growing body of clinical evidence for Personal Continuous Glucose Monitoring (CGM) in improving glucose control for diabetes patients.

16 Nov 2009

New technique to cool the brains of cardiac arrest patients

The first randomized intra-arrest cooling study performed using a novel intra-nasal cooling method showed much faster and earlier cooling in treated patients and significantly higher neurologically intact survival - to - discharge rate in many patients. The Pre-Resuscitation Intra-Nasal Cooling Effectiveness (PRINCE) study involved 200 patients and was conducted by 15 Emergency Medical Systems (EMS) in Belgium, Germany, Italy, Czech Republic and Sweden.

16 Nov 2009

Recent releases in Global Health

As a follow-up to a survey conducted in May 2009, this poll examines Americans' attitudes toward U.S. global health investments and priorities.

16 Nov 2009

Ore Pharmaceutical Holdings reports financial results and provides operational updates for third quarter 2009

Ore Pharmaceutical Holdings Inc. today reported financial results and provided an operational update for the third quarter ended September 30, 2009.

13 Nov 2009

Axelar AB to present data from ongoing Phase I/II clinical trial of AXL1717

Axelar AB today announced that promising data from the ongoing Phase I/II clinical trial concerning their lead anticancer product AXL1717, an insulin-like growth factor-1 (IGF-1) receptor inhibitor, will be presented next week at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Boston, Massachusetts, USA.

13 Nov 2009

CSHL solves the structure of the zinc-bound ATD domain of the NMDA receptor NR2B subunit

A team of scientists at Cold Spring Harbor Laboratory (CSHL) reports on Thursday their success in solving the molecular structure of a key portion of a cellular receptor implicated in Alzheimer's, Parkinson's, and other serious illnesses.

13 Nov 2009

Findings on the use of Traumeel S in children with mucositis undergoing SCT presented

New research findings presented today at the Society for Integrative Oncology's (SIO) Sixth International Conference in New York show promise in assessing the efficacy and safety of complementary and alternative medicine (CAM) using traditional research methods.

13 Nov 2009

Vanderbilt University researchers study role of statins in reducing flu-related deaths

Vanderbilt University Medical Center researchers are studying statins, the class of drugs long associated with lowering cholesterol, as a way to reduce H1N1-related deaths.

13 Nov 2009

CSL's H1N1 influenza vaccine receives approval from FDA for use in children ages 6 months and older

The U.S. Food and Drug Administration has approved the use of the CSL Limited's 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

13 Nov 2009

Ipsen receives marketing authorization in France for its 6-month sustained-release formulation of Decapeptyl

Ipsen, an innovation-driven global specialty pharmaceutical Group announces that the French regulatory authorities (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS) have today granted the marketing authorization to the 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate 22.5 mg) for the treatment of locally advanced and metastatic prostate cancer.

13 Nov 2009

Efficacy News and Research

FDA's BPAC renders positive opinion on Phase III clinical trial of INTERCEPT Blood System

Roche receives EUA from FDA for its RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 virus

ARCA biopharma provides financial and Gencaro NDA update

Additional data from Aegerion Pharmaceuticals' ongoing lomitapide Phase III trial

Decision Resources: Neuropathic pain drug market to be $9.7B in 2018

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Positive results from Winston Laboratories' Civamide Patch trial

Aradigm commences patient dosage in Phase 2 trial of novel inhaled ciprofloxacin formulation

FDA issues a Complete Response Letter for Human Genome Sciences' raxibacumab BLA

SANUWAVE Health reports financial results for the three months ended September 30, 2009

Personal CGM improves glucose control for diabetes patients

New technique to cool the brains of cardiac arrest patients

Recent releases in Global Health

Ore Pharmaceutical Holdings reports financial results and provides operational updates for third quarter 2009

Axelar AB to present data from ongoing Phase I/II clinical trial of AXL1717

CSHL solves the structure of the zinc-bound ATD domain of the NMDA receptor NR2B subunit

Findings on the use of Traumeel S in children with mucositis undergoing SCT presented

Vanderbilt University researchers study role of statins in reducing flu-related deaths

CSL's H1N1 influenza vaccine receives approval from FDA for use in children ages 6 months and older

Ipsen receives marketing authorization in France for its 6-month sustained-release formulation of Decapeptyl

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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