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Penn Medicine devises new approach to develop vaccines against lethal diseases

Researchers at the Perelman School of Medicine at the University of Pennsylvania have devised an entirely new approach to vaccines - creating immunity without vaccination.

4 Aug 2015

Engineered protein shown effective in patients with severe von Willebrand disease

The first protein engineered to help control bleeding episodes in patients with severe von Willebrand disease (vW disease) has been shown to be safe and effective, according to results of a Phase III trial.

4 Aug 2015

Shionogi’s naldemedine meets primary, secondary endpoints for treatment of opioid-induced constipation

Shionogi today announced that once-daily naldemedine met its primary and secondary endpoints in a phase III study (COMPOSE II) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

3 Aug 2015

Exalenz Bioscience, Galectin Therapeutics to use BreathID test to assess GR-MD-O2 efficacy in NASH Cirrhosis patients

Exalenz Bioscience, a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced a collaboration with Galectin Therapeutics to use the BreathID test to monitor patients in a Phase II study evaluating GR-MD-02.

3 Aug 2015

Shire acquires Foresight Biotherapeutics for $300 million

Shire plc announced today that it has acquired New York-based, privately held Foresight Biotherapeutics Inc. for $300 million.

3 Aug 2015

First large field trial shows VSV-ZEBOV is effective against Ebola

A vaccine against the Ebola virus, tested in West Africa for the first time in a field trial, has proved to be effective. People who had come into close contact with someone recently infected, and who are therefore at particularly high risk, were vaccinated.

3 Aug 2015

Tests show VSV-ZEBOV vaccine safe and effective against Ebola

Tests of the experimental Ebola vaccine VSV-ZEBOV in over 7500 participants in Guinea suggest that the vaccine provides high protection against the disease as early as ten days after vaccination, in adults who have potentially been exposed to the virus by coming in close contact with a recently infected person.

31 Jul 2015

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours.

31 Jul 2015

Guinea Phase III trial shows VSV-EBOV vaccine highly effective against Ebola

Results from an interim analysis of the Guinea Phase III efficacy vaccine trial show that VSV-EBOV (Merck, Sharp & Dohme) is highly effective against Ebola.

31 Jul 2015

Daiichi Sankyo, Plexxikon’s Phase 1 trial shows PLX3397 induced prolonged tumor regression in TGCT patients

Daiichi Sankyo Europe and Plexxikon Inc., a member of the Daiichi Sankyo Group, announced today that The New England Journal of Medicine published clinical trial results demonstrating that the investigational drug, PLX3397, an oral targeted CSF-1R inhibitor, induced prolonged tumor regressions in most patients with tenosynovial giant cell tumor, a rare, locally aggressive neoplasm of the joint or tendon sheath.

31 Jul 2015

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

Tissue Regenix Group, the regenerative medical devices company, announces that it has further strengthened its position within the post-acute wound care market as Tissue Regenix Wound Care Inc. has received further approval for DermaPure under Medicare administrator, First Coast Service Options Inc. whose jurisdiction includes Florida, Puerto Rico and the US Virgin Islands.

30 Jul 2015

NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

Isis Pharmaceuticals, Inc., the leader in RNA-targeted therapeutics, and Akcea Therapeutics, its wholly owned subsidiary, announced today that The New England Journal of Medicine (NEJM) has published positive clinical results from a Phase 2 clinical study evaluating volanesorsen (formerly ISIS-APOCIII Rx) in patients with very high to severely high triglycerides.

30 Jul 2015

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.

30 Jul 2015

Finding by UCSF researchers could increase availability of kidneys for transplant

Mild hypothermia in deceased organ donors significantly reduces delayed graft function in kidney transplant recipients when compared to normal body temperature, according to UC San Francisco researchers and collaborators, a finding that could lead to an increase in the availability of kidneys for transplant.

30 Jul 2015

New study reports creation of genetic porcine model of cancer

With many types of cancers, early detection offers the best hope for survival. However, research into new early-detection screenings, as well as possible interventional radiology and surgical treatments, has been hindered by the lack of a large animal model that would accurately reflect the types of cancers seen in human cells.

30 Jul 2015

Aeterna Zentaris selects optimized Erk inhibitor molecule for further development

Aeterna Zentaris Inc. today announced it has selected an optimized Erk inhibitor molecule for development, thus achieving another important milestone in the development of a new class of potential cancer therapies.

29 Jul 2015

LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and compared with insulin glargine 100 units/mL.

29 Jul 2015

New consortium aims to develop precision medicines for globally devastating diseases

An innovative new Consortium will act as a ‘match-making’ service between pharmaceutical companies and researchers in Cambridge with the aim of developing and studying precision medicines for some of the most globally devastating diseases.

29 Jul 2015

Moerae announces initiation of second MMI-0100 Phase 1 clinical trial for pulmonary disorders

Moerae Matrix Inc. announced today the initiation of its second Phase 1 clinical trial with MMI-0100, a first-in-class inhibitor of MAPKAP kinase 2 (MK2) that is being developed for pulmonary disorders characterized by inflammation and fibrosis. The study, conducted in the United Kingdom, is a double-blind, two-way cross-over design lipopolysaccharide (LPS) challenge study further evaluating the safety and tolerability of MMI-0100 when given via inhalation to healthy subjects who smoke.

29 Jul 2015

New polymer gel could help create swallowable devices for ultra-long drug delivery

Medical devices designed to reside in the stomach have a variety of applications, including prolonged drug delivery, electronic monitoring, and weight-loss intervention. However, these devices, often created with nondegradable elastic polymers, bear an inherent risk of intestinal obstruction as a result of accidental fracture or migration. As such, they are usually designed to remain in the stomach for a limited time.

29 Jul 2015

Efficacy News and Research

Penn Medicine devises new approach to develop vaccines against lethal diseases

Engineered protein shown effective in patients with severe von Willebrand disease

Shionogi’s naldemedine meets primary, secondary endpoints for treatment of opioid-induced constipation

Exalenz Bioscience, Galectin Therapeutics to use BreathID test to assess GR-MD-O2 efficacy in NASH Cirrhosis patients

Shire acquires Foresight Biotherapeutics for $300 million

First large field trial shows VSV-ZEBOV is effective against Ebola

Tests show VSV-ZEBOV vaccine safe and effective against Ebola

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Guinea Phase III trial shows VSV-EBOV vaccine highly effective against Ebola

Daiichi Sankyo, Plexxikon’s Phase 1 trial shows PLX3397 induced prolonged tumor regression in TGCT patients

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Finding by UCSF researchers could increase availability of kidneys for transplant

New study reports creation of genetic porcine model of cancer

Aeterna Zentaris selects optimized Erk inhibitor molecule for further development

LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

New consortium aims to develop precision medicines for globally devastating diseases

Moerae announces initiation of second MMI-0100 Phase 1 clinical trial for pulmonary disorders

New polymer gel could help create swallowable devices for ultra-long drug delivery

Industry Focus eBook - Analytical Chemistry (2nd Edition) eBook

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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