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An Introduction to Specialty Pharmaceuticals

In this interview, News Medical talks to David Moran, Managing Director of Clinigen SP about specialty pharmaceuticals.

From Clinigen Group 29 Aug 2016

Leading Chikungunya vaccine in clinical trial phase 2

With the first patient vaccinated, a Phase 2 clinical trial of a promising prophylactic vaccine candidate against Chikungunya fever has now commenced. The product is the most advanced Chikungunya vaccine candidate globally and is developed by the Austrian biotech company Themis Bioscience GmbH.

29 Aug 2016

Janssen seeks to extend DARZALEX license to benefit more multiple myeloma patients

Janssen-Cilag International NV has announced the submission of a Type II variation application to the European Medicines Agency (EMA), seeking to broaden the existing marketing authorisation for the immunotherapy DARZALEX® (daratumumab) to include treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. The expanded indication is based on daratumumab in combination with lenalidomide (an immmunomodulatory agent) and dexamethasone, or bortezomib (a PI) and dexamethasone.

29 Aug 2016

NEJM publishes MINDACT trial results

Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces the peer-reviewed publication of the primary outcome results of the Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) clinical trial in the prestigious New England Journal of Medicine (NEJM). (i, iii, iv) The publication demonstrates that 46% of breast cancer patients considered for chemotherapy, whose tumors are classified MammaPrint Low Risk, have excellent survival without chemotherapy, and can thus be candidates to avoid this toxic therapy.

29 Aug 2016

MRI-guided focused ultrasound treatment improves quality of life in patients with essential tremor

Treatment with MRI-guided focused ultrasound significantly improves tremors and quality of life in patients with essential tremor (ET), the most common movement disorder, according to a study published in the August 25 issue of the New England Journal of Medicine.

27 Aug 2016

Can-Fite BioPharma reports financial results, provides update on drug development programs

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today reported financial results for the six months ended June 30, 2016 and updates on its drug development programs.

27 Aug 2016

Anesthetic administered with nasal spray effective in preventing pain during dental treatment

A fear of pain causes many people with dental phobias to avoid or delay needed treatment. In some cases, the injection of a numbing agent can be the most painful part of the visit.

26 Aug 2016

SSRI treatment improves cognitive and social functioning in young children with fragile X

Treatment with sertraline may provide nominal but important improvements in cognition and social participation in very young children with fragile X syndrome, the most common genetic cause of intellectual disability and the leading single-gene cause of autism, a study by researchers with the UC Davis MIND Institute has found.

26 Aug 2016

Novel small-molecule Wnt inhibitor may provide new treatment option for colorectal cancer patients

A team including the National Cancer Center, the RIKEN Center for Life Science Technologies , and Carna Biosciences Inc., has jointly announced the development of a novel small-molecule Wnt inhibitor named NCB-0846.

26 Aug 2016

Oventus reports early revenues, establishes platform for accelerated growth

Medical device sleep apnoea and snoring disorder company Oventus Medical Ltd. releases its first 4E. The company has established a platform for accelerated growth following a successful IPO raising $12 million and is reporting encouraging early revenue.

26 Aug 2016

PinnacleHealth replaces aortic valve in two patients using minimally invasive surgery

This week, PinnacleHealth became the first hospital in the country to implant the EDWARDS INTUITY Elite valve, a rapid deployment device for surgical aortic valve replacement, after U.S. Food and Drug Administration approval.

26 Aug 2016

High-tech alternative to brain surgery safe, effective for treatment of essential tremor

A study published today in the prestigious New England Journal of Medicine offers the most in-depth assessment yet of the safety and effectiveness of a high-tech alternative to brain surgery to treat the uncontrollable shaking caused by the most common movement disorder.

25 Aug 2016

Three like-minded nonprofits collaborate to launch immunotherapy clinical trial for pediatric brain tumors

A Kids' Brain Tumor Cure Foundation, Solving Kids' Cancer and the Ty Louis Campbell Foundation announce their joint financial support of a Phase 1 clinical trial to test the safety and efficacy of combination checkpoint inhibitors in the treatment of children with brain tumors.

25 Aug 2016

New noninvasive treatment option improves quality of life in patients with essential tremor

25 Aug 2016

Diabetes drug linked to decreased weight gain in children with autism spectrum disorder

The diabetes medication metformin hydrochloride was associated with decreased weight gain in a small clinical trial of children and adolescents with autism spectrum disorder who were taking atypical antipsychotics to treat symptoms of irritability and agitation, according to an article published online by JAMA Psychiatry.

24 Aug 2016

National MS Society awards grant to investigate impact of popular diets on multiple sclerosis-related fatigue

The National Multiple Sclerosis Society has just committed over $1 million to support a clinical trial at the University of Iowa led by Terry Wahls, MD, to compare the ability of two popular diets to treat multiple sclerosis-related fatigue, a disabling symptom that can significantly interfere with a person's ability to function at home and work.

24 Aug 2016

European scientists invent new microscope for rapid detection of deadly infections

A group of European scientists have invented a microscope that will allow the fastest ever detection of life-threatening infections caused by bacteria, such as E. coli or Staphylococcus, and conditions such as Meningitis, saving millions of lives every year.

24 Aug 2016

Breast cancer patients in the U.S. now have new surgical option that offers flexible alternative for cancer detection

Breast cancer patients in the U.S. will have a new surgical option that eliminates exposure to radioactive materials and offers a less invasive, more flexible alternative for cancer detection. Receiving FDA approval in April and a distribution deal this month, the new device will be used to locate early stage tumors that cannot yet be felt.

24 Aug 2016

Scientists discover less invasive, cheaper technique to improve woman's chances of becoming pregnant

For those facing infertility, IVF has long been the established option to have a baby. Now Australian and Belgian medical scientists have discovered how to improve a woman's chances of becoming pregnant using a less invasive and cheaper alternative.

23 Aug 2016

Seeds of tropical shrub guarana contain ten times more amount of catechins than green tea

The millions of people who consume green tea all over the world benefit from the catechins it contains.

22 Aug 2016

Clinical Trial News and Research

An Introduction to Specialty Pharmaceuticals

Leading Chikungunya vaccine in clinical trial phase 2

Janssen seeks to extend DARZALEX license to benefit more multiple myeloma patients

NEJM publishes MINDACT trial results

MRI-guided focused ultrasound treatment improves quality of life in patients with essential tremor

Can-Fite BioPharma reports financial results, provides update on drug development programs

Anesthetic administered with nasal spray effective in preventing pain during dental treatment

SSRI treatment improves cognitive and social functioning in young children with fragile X

Novel small-molecule Wnt inhibitor may provide new treatment option for colorectal cancer patients

Oventus reports early revenues, establishes platform for accelerated growth

PinnacleHealth replaces aortic valve in two patients using minimally invasive surgery

High-tech alternative to brain surgery safe, effective for treatment of essential tremor

Three like-minded nonprofits collaborate to launch immunotherapy clinical trial for pediatric brain tumors

New noninvasive treatment option improves quality of life in patients with essential tremor

Diabetes drug linked to decreased weight gain in children with autism spectrum disorder

National MS Society awards grant to investigate impact of popular diets on multiple sclerosis-related fatigue

European scientists invent new microscope for rapid detection of deadly infections

Breast cancer patients in the U.S. now have new surgical option that offers flexible alternative for cancer detection

Scientists discover less invasive, cheaper technique to improve woman's chances of becoming pregnant

Seeds of tropical shrub guarana contain ten times more amount of catechins than green tea

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