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Isis Pharmaceuticals reports pro forma net operating loss of $22.6 million for Q1 2014

Isis Pharmaceuticals, Inc. today reported a pro forma net operating loss (NOL) of $22.6 million for the three months ended March 31, 2014 compared to pro forma operating income of $4.5 million for the same period in 2013.

6 May 2014

FDA accepts Merck's MK-3475 BLA for review

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) for MK-3475, Merck's investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab.

6 May 2014

Novartis presents Phase III results of Signifor LAR therapy in patients with acromegaly

Novartis today presented results from a pivotal Phase III trial of investigational therapy Signifor® LAR (pasireotide LAR; SOM230) in patients with acromegaly for whom current standard of care provides inadequate disease control.

6 May 2014

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

UCB announced today results from the PRECiSE 3 7-year open label extension clinical trial of Cimzia (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease.

6 May 2014

Attorney of Colson Hicks Eidson files wrongful death complaint on behalf of passenger killed on Macarthur Causeway

Attorney Ervin A. Gonzalez, partner at the Coral Gables-based law firm Colson Hicks Eidson, filed a wrongful death complaint in the 11th Judicial Circuit Court in Miami-Dade County on behalf of the family of the late Dr. Malcolm Lloyd, passenger in the Lamborghini that was involved in a fatal car crash on April 24th on MacArthur Causeway.

6 May 2014

New phase III clinical trial shows non-invasive focused ultrasound treatment relieves cancer pain

When cancer progresses and spreads to the bone, patients often suffer debilitating pain. Now, a new phase III clinical trial shows that non-invasive magnetic resonance guided focused ultrasound treatment that heats the cancer within the bone, relieves pain and improves function for most patients when other treatment options are limited.

6 May 2014

Young blood can rejuvenate brains of old mice

Something - or some things - in the blood of young mice has the ability to restore mental capabilities in old mice, a new study by Stanford University School of Medicine investigators has found.

6 May 2014

BeiGene receives $5M from Merck to develop BGB-283 BRAF inhibitor

BeiGene (Beijing), Co., Ltd., an innovative oncology company focused on developing targeted and immune-oncology therapeutics, today announced the achievement of a clinical milestone in the company's collaboration with Merck Serono, the biopharmaceutical division of Merck, Darmstadt, Germany, for BGB-283, a second-generation BRAF inhibitor candidate currently in Phase 1 development.

6 May 2014

ERYTECH Pharma gets authorization to initiate Phase II study in pancreatic cancer

ERYTECH Pharma, a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces that the ANSM, French healthcare agency, has granted the authorization to start a Phase II study in second line treatment of patients affected by pancreatic cancer.

6 May 2014

Factors that lead to diabetes contribute to low milk supply in some new mothers

New studies provide fresh evidence that the same factors that lead to diabetes contribute to low milk supply in some new mothers.

6 May 2014

Virtual patient, medical record and questions appear effective in recognizing suicide risk

A virtual patient, the electronic medical record, and questions about how well patients sleep appear effective new tools in recognizing suicide risk, researchers say.

6 May 2014

MEI Pharma begins ME-344 Phase Ib clinical study in patients with solid tumors

MEI Pharma, Inc., an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patient has been dosed in a Phase Ib clinical study of its investigational mitochondrial inhibitor drug candidate ME-344 in combination with Hycamtin (topotecan) in patients with solid tumors, including small cell lung and ovarian cancers.

6 May 2014

New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

New two-year data from the Phase 3 ADVANCE clinical trial for peginterferon beta-1a in adults with relapsing forms of multiple sclerosis (RMS) has been presented at the 66th American Academy of Neurology (AAN) annual meeting.

5 May 2014

High doses of steroids fail to improve outcomes in pediatric liver disease

A multi-center study concludes that treating infants with high doses of steroids fails to improve medical outcomes in the end-stage pediatric liver disease biliary atresia and leads to earlier onset of serious adverse events.

5 May 2014

Researchers evaluate treatment guidelines for African Americans with asthma

In a first-of-its-kind clinical trial, asthma researchers at University Hospitals Rainbow Babies & Children's Hospital (UH Rainbow) will evaluate treatment guidelines for African American children and young adults with asthma.

5 May 2014

Long-term use of drug combination reduces risk of recurrent urinary tract infection in children

Long-term use of a drug combination reduces the risk of recurrent urinary tract infection by up to 80 percent in children with the urinary condition vesicoureteral reflux compared to placebo, according to research funded by the National Institutes of Health.

5 May 2014

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Ruthigen, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, today announced that the Company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for its lead drug candidate RUT58-60.

2 May 2014

FDA approves Parion’s investigational new drug application for treatment of dry eye disease

Parion Sciences, a company dedicated to the development of novel treatments for ocular and pulmonary diseases, announced today that it has received acceptance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for P-321 Ophthalmic Solution for the treatment of dry eye disease.

2 May 2014

Richard M. Ross Heart Hospital docs implanted smallest heart pacemaker in Columbus woman

It's about the size of a large vitamin pill and, for the first time in Ohio, the smallest heart pacemaker available is being tested at The Ohio State University Wexner Medical Center.

From Medtronic 2 May 2014

LUNGevity Foundation welcomes FDA approval of Zykadia drug for advanced stages of lung cancer

LUNGevity Foundation applauds the FDA approval of Zykadia™ for the subset of anaplastic lymphoma kinase-positive (ALK+) patients with advanced cases of non-small cell lung cancer who have progressed on or are intolerant to crizotinib.

2 May 2014

Clinical Trial News and Research

Isis Pharmaceuticals reports pro forma net operating loss of $22.6 million for Q1 2014

FDA accepts Merck's MK-3475 BLA for review

Novartis presents Phase III results of Signifor LAR therapy in patients with acromegaly

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

Attorney of Colson Hicks Eidson files wrongful death complaint on behalf of passenger killed on Macarthur Causeway

New phase III clinical trial shows non-invasive focused ultrasound treatment relieves cancer pain

Young blood can rejuvenate brains of old mice

BeiGene receives $5M from Merck to develop BGB-283 BRAF inhibitor

ERYTECH Pharma gets authorization to initiate Phase II study in pancreatic cancer

Factors that lead to diabetes contribute to low milk supply in some new mothers

Virtual patient, medical record and questions appear effective in recognizing suicide risk

MEI Pharma begins ME-344 Phase Ib clinical study in patients with solid tumors

New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

High doses of steroids fail to improve outcomes in pediatric liver disease

Researchers evaluate treatment guidelines for African Americans with asthma

Long-term use of drug combination reduces risk of recurrent urinary tract infection in children

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

FDA approves Parion’s investigational new drug application for treatment of dry eye disease

Richard M. Ross Heart Hospital docs implanted smallest heart pacemaker in Columbus woman

LUNGevity Foundation welcomes FDA approval of Zykadia drug for advanced stages of lung cancer

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