Efficacy News and Research

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Novel non-invasive method of vagus nerve stimulation reduces depressive symptoms

Researchers of a new study published in the current issue of Biological Psychiatry report successful reduction of depressive symptoms in patients using a novel non-invasive method of vagus nerve stimulation, or VNS.

5 Feb 2016

Natalizumab shows relapse prevention benefits over fingolimod in MS

Natalizumab may be superior to fingolimod for preventing relapses during the first year of treatment in patients with relapsing–remitting multiple sclerosis, observational study findings show.

4 Feb 2016

AstraZeneca’s TAGRISSO (osimertinib) approved in EU for metastatic EGFR T790M mutation-positive NSCLC

AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

4 Feb 2016

Study shows several Envigo rat models susceptible to genital HSV-2 infection

A scientific collaboration between Envigo and the Department of Infectious Disease at the University of Gothenburg, Sweden has unveiled study findings into rat models and their susceptibility to intra-vaginal herpes simplex virus-2 (HSV-2) infection.

2 Feb 2016

RegeneRx Biopharmaceuticals announces completion of enrollment for Phase 2b/3 dry eye trial in U.S.

RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its U.S. joint venture with G-treeBNT, ReGenTree LLC, has completed enrollment of its Phase 2b/3 dry eye trial in the U.S.

29 Jan 2016

UCLA researchers find protein combination that could improve clinical bone restoration

A UCLA research team has found a combination of proteins that could significantly improve clinical bone restoration. The findings may be a big step toward developing effective therapeutic treatments for bone skeletal defects, bone loss and osteoporosis.

29 Jan 2016

New treatment could stop progression of ALS

Researchers at Oregon State University announced today that they have essentially stopped the progression of amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, for nearly two years in one type of mouse model used to study the disease - allowing the mice to approach their normal lifespan.

29 Jan 2016

VARI-SU2C Epigenetics Dream Team supports new clinical trial that targets metastatic colorectal cancer

The first clinical trial to move forward as part of the Van Andel Research Institute-Stand Up To Cancer (VARI-SU2C) Epigenetics Dream Team will target metastatic colorectal cancer, the second leading cause of cancer deaths among men and women combined in the U.S.

29 Jan 2016

Zepatier receives FDA approval for treatment of chronic HCV genotypes 1 and 4 infections

The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

29 Jan 2016

AbbVie announces initiation of first Elagolix Phase 3 study in patients with uterine fibroid

AbbVie, in cooperation with Neurocrine Biosciences, Inc., today announced the initiation of the first of two planned Phase 3 clinical studies evaluating the safety and efficacy of Elagolix alone or in combination with add-back therapy compared to placebo.

29 Jan 2016

Halaven (eribulin mesylate) approved for treatment of liposarcoma

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

28 Jan 2016

Dysport phase III study results in children with cerebral palsy with lower limb spasticity published in Pediatrics

Ipsen today announced that the scientific journal Pediatrics published the detailed results of the phase III randomized study showing both the efficacy and the safety of Dysport in the treatment of dynamic equinus foot deformity, a condition associated with cerebral palsy in children.

28 Jan 2016

Educational programs, new clinic policies could significantly reduce level of opioid medication

A recent study showed that medical provider training, new clinic policies and efforts to "taper" opioid use for pain treatment could significantly reduce the level of opioid medication that patients used -- a limited but positive step for a nation enmeshed in opioid use, abuse and overdose deaths.

27 Jan 2016

FDA expands use of Opdivo + Yervoy Regimen for BRAF V600 mutant and wild-type advanced melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved Opdivo in combination with Yervoy for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.

27 Jan 2016

Palonosetron effective anti-emetic for paediatric chemotherapy patients

Palonosetron 20 μg/kg is noninferior to ondansetron for the control of chemotherapy-induced vomiting and nausea during the acute phase of the first treatment cycle in paediatric patients with cancer, research shows.

26 Jan 2016

BioLineRx's BL-7010 confirmed as Class IIb medical device in European Union

BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has received confirmation from the European Notified Body regarding the classification of BL-7010, a novel polymer for the treatment of celiac disease, as a Class IIb medical device in the European Union.

25 Jan 2016

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Shire plc today announced it has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA on October 16, 2015.

25 Jan 2016

Efficacy News and Research

Novel non-invasive method of vagus nerve stimulation reduces depressive symptoms

Natalizumab shows relapse prevention benefits over fingolimod in MS

AstraZeneca’s TAGRISSO (osimertinib) approved in EU for metastatic EGFR T790M mutation-positive NSCLC

Study shows several Envigo rat models susceptible to genital HSV-2 infection

RegeneRx Biopharmaceuticals announces completion of enrollment for Phase 2b/3 dry eye trial in U.S.

UCLA researchers find protein combination that could improve clinical bone restoration

New treatment could stop progression of ALS

VARI-SU2C Epigenetics Dream Team supports new clinical trial that targets metastatic colorectal cancer

Zepatier receives FDA approval for treatment of chronic HCV genotypes 1 and 4 infections

AbbVie announces initiation of first Elagolix Phase 3 study in patients with uterine fibroid

Halaven (eribulin mesylate) approved for treatment of liposarcoma

Dysport phase III study results in children with cerebral palsy with lower limb spasticity published in Pediatrics

Educational programs, new clinic policies could significantly reduce level of opioid medication

FDA expands use of Opdivo + Yervoy Regimen for BRAF V600 mutant and wild-type advanced melanoma

Palonosetron effective anti-emetic for paediatric chemotherapy patients

BioLineRx's BL-7010 confirmed as Class IIb medical device in European Union

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Carbapenem-resistant Enterobacteriaceae: an interview with Dr. Michael Dudley

Epidural analgesia has some adverse effects on newborns

Positive bosutinib response for elderly blast phase CML patient

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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