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Industry sponsored drug and device studies: an interview with Professor Lisa Bero

Our review included analyses of drug and device studies conducted in humans. The drugs or devices could be compared to placebo or sham treatments, or other effective treatments. The drugs and devices examined for this review are used for a wide variety of clinical conditions, including cardiovascular and psychiatric diseases.

7 Jan 2013

Edison Pharmaceuticals to commence EPI-743 phase 2B Friedreich's ataxia study

Edison Pharmaceuticals today announced the initiation of a phase 2B study entitled, "Safety and Efficacy Study of EPI-743 on Visual Function in Patients with Friedreich's Ataxia."

7 Jan 2013

arGEN-X commences ARGX-110 Phase Ib trial to treat cancer

arGEN-X, a biopharmaceutical company specialized in the discovery and development of highly differentiated human monoclonal antibody therapeutics, announced today the initiation of a Phase Ib first-in-man cancer study with ARGX-110, its first SIMPLE Antibody program to enter the clinic in just three years from initiation of discovery.

7 Jan 2013

Inovio, MVI collaborate to advance malaria vaccine development and new delivery technologies

The PATH Malaria Vaccine Initiative (MVI) and Inovio Pharmaceuticals, Inc. today announced a follow-on collaboration to advance malaria vaccine development and new vaccination delivery technologies.

7 Jan 2013

Rhythm commences RM-493 Phase 2 trial in obesity

Rhythm announced today the initiation of a Phase 2 clinical trial with RM-493, the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of obesity.

7 Jan 2013

Top-line results from Biogen Idec’s dexpramipexole Phase 3 trial on amyotrophic lateral sclerosis

Today Biogen Idec reported top-line results of EMPOWER, a Phase 3 trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS).

3 Jan 2013

Pfizer, Repligen sign licensing deal to advance spinal muscular atrophy program

Repligen Corporation announced today that it has entered into an exclusive worldwide licensing agreement with Pfizer Inc. to advance Repligen's spinal muscular atrophy (SMA) program, originally in-licensed from Families of SMA (FSMA).

3 Jan 2013

Celtaxsys commences CTX-4430 Phase 1 study to treat pulmonary inflammation

Celtaxsys, Inc., a private biopharmaceutical company developing a new class of drugs to treat chronic inflammatory disorders, today announced the initiation of a first-in-human Phase 1 clinical study of CTX-4430, which blocks the pro-inflammatory enzyme Leukotriene A4 Hydrolase (LTA4H).

3 Jan 2013

$Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer$

Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival.

3 Jan 2013

Kareus announces start of KU-046 Phase I study in Alzheimer's

Kareus Therapeutics SA, the private biotechnology company focused on the development of novel therapeutics for the unmet treatment of age-related and chronic diseases, today announces the start of a Phase I clinical study following the Investigational New Drug (IND) approval from the US Food and Drug Administration for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer's disease using Kareus' proprietary bioenergetics and KARLECT platforms.

3 Jan 2013

EPIRUS’ BOW-015 achieves bioequivalence to Remicade in a single dose comparator trial

EPIRUS Biopharmaceuticals, Inc., formerly known as fourteen22 Inc, announced that its lead asset, BOW-015, achieved bioequivalence to Remicade in a single dose comparator trial.

3 Jan 2013

Soligenix's OrbeShield granted FDA oral BDP orphan drug designation

Soligenix, Inc., a development stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

2 Jan 2013

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Aeterna Zentaris Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.

29 Dec 2012

Juxtapid receives FDA approval for treatment of rare cholesterol disorder

On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.

27 Dec 2012

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Blue Chip Patient Recruitment, a division of Blue Chip Marketing Worldwide, a full-service integrated marketing agency, has successfully partnered with Orexigen Therapeutics to accelerate patient enrollment of The Light Study, Orexigen's cardiovascular outcomes trial evaluating Contrave (naltrexone sustained release (SR)/bupropion SR).

21 Dec 2012

Halozyme grants Pfizer worldwide license to develop products combining Enhanze with biologics

Halozyme Therapeutics, Inc. announced today that it has entered into a worldwide Collaboration and License Agreement with Pfizer Inc. for the purpose of developing and commercializing products combining proprietary Pfizer biologics with Halozyme's Enhanze technology.

21 Dec 2012

Gene therapy shows promise for severe coronary artery disease

Diagnosed with severe coronary artery disease, a group of patients too ill for or not responding to other treatment options decided to take part in a clinical trial testing angiogenic gene therapy to help rebuild their damaged blood vessels.

21 Dec 2012

OncoMed commences dosing in OMP-52M51 Phase 1 clinical trial for hematologic cancers

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in a Phase 1 clinical trial of OMP-52M51 in patients with hematologic cancers.

21 Dec 2012

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.

21 Dec 2012

Drug Trial News

Industry sponsored drug and device studies: an interview with Professor Lisa Bero

Edison Pharmaceuticals to commence EPI-743 phase 2B Friedreich's ataxia study

arGEN-X commences ARGX-110 Phase Ib trial to treat cancer

Inovio, MVI collaborate to advance malaria vaccine development and new delivery technologies

Rhythm commences RM-493 Phase 2 trial in obesity

Top-line results from Biogen Idec’s dexpramipexole Phase 3 trial on amyotrophic lateral sclerosis

Pfizer, Repligen sign licensing deal to advance spinal muscular atrophy program

Celtaxsys commences CTX-4430 Phase 1 study to treat pulmonary inflammation

Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer

Kareus announces start of KU-046 Phase I study in Alzheimer's

EPIRUS’ BOW-015 achieves bioequivalence to Remicade in a single dose comparator trial

Soligenix's OrbeShield granted FDA oral BDP orphan drug designation

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Juxtapid receives FDA approval for treatment of rare cholesterol disorder

AMAG seeks FDA sNDA approval for Feraheme Injection

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Halozyme grants Pfizer worldwide license to develop products combining Enhanze with biologics

Gene therapy shows promise for severe coronary artery disease

OncoMed commences dosing in OMP-52M51 Phase 1 clinical trial for hematologic cancers

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

How electrical engineering ensures accurate calibration and patient safety

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