MediSphere Medical Research Center is excited to announce the F.D.A. Approval of the following drugs.These important milestones in delivering on the promise of new drugs to patients would not be possible without the cooperation of our patients who participated in the clinical research studies.  

Thank you for your ongoing support.

Synergy Trulance

January 19, 2017

Another successful trial at MediSphere Medical Research Center, LLC:

The U.S. Food and Drug Administration (FDA) has approved Trulance™ (plecanatide) for the treatment of adults with chronic constipation of unknown cause (CIC). Trulance is the first drug designed to replicate a naturally occurring compound thought to stimulate fluid secretion in the gastrointestinal (GI) tract. Based on pre-clinical studies, this results in a stool consistency associated with more regular bowel function. * Synergy’s plan is to make Trulance available in the U.S. later this quarter. (Excerpted from press release)

The MediSphere team extends its deepest gratitude to all of our patients who participate in clinical trials that bring new medicines to market.

Another successful Diabetes clinical trial at MediSphere

On November 21st, 2016 the U.S. Food and Drug Administration approved SOLIQUA™ 100/33. SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, that may improve blood sugar (glucose) control in adults with type 2 diabetes. It is indicated for daily use with diet and exercise in people who are not controlled with long-acting (basal) insulin (less than 60 units daily) or lixisenatide. It will be available in a convenient single one-use pen.

Thank you to all of our clients who participated in this clinical trial. New drugs would not come to market without the significant effort put forth by all.

 

November 16, 2016

Successful Phase 3 Trial at MediSphere

Erenumab Co-Developed by Amgen and Novartis for Episodic Migraine Prevention

Pharmaceutical company, Amgen, has announced positive top-line results for erenumab from a global Phase 3, STudy to evaluate the efficacy and safety of erenumab in migRaIne preVEntion (STRIVE). Erenumab is specifically designed to prevent migraine by blocking the receptor which is believed to have a critical role in mediating the incapacitating pain of migraine. Amgen stated, “The results of this study are important because they confirm the results from our previous studies and add to our body of research in episodic migraine. We look forward to working with regulatory authorities to pursue approval of erenumab and making this novel migraine prevention treatment available to patients and physicians.” (Excerpted from Nov. 16, 2016 /PRNewswire)

As always, the MediSphere team thanks all of our patients who participated in this very important drug trial. Participation in clinical trials is an imperative to making safe, effective drugs available to patients and physicians.

For more information visit:

http://wwwext.amgen.com/media/news-releases/2016/11/amgen-announces-erenumab-significantly-reduces-monthly-migraine-days-in-patients-with-episodic-migraine-in-second-phase-3-study/

 

Congratulations to Dr Alex Dela Llana and MediSphere staff for receiving the Novartis Cantos Recognition Award

 

Congratulations to Dr Alex Dela Llana and MediSphere staff for receiving the Novartis Cantos Recognition Award 

August 19, 2016

We participated in a drug trial by Novartis for a new use of the drug ILARIS. ILARIS is now approved by the FDA for use in preventing / lowering the risk of recurrent heart events such as heart attack and stroke.

Novo Nordisk receives US FDA approval for Tresiba® and Ryzodeg® 70/30

September 25, 2015

Tresiba®, the approved brand name for insulin degludec, is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours. In ‘treat-to-target’ studies comparing Tresiba® to insulin glargine, people using Tresiba® achieved similar reduction in long-term blood glucose (HbA1c), numerically greater fasting plasma glucose reduction, while using numerically lower doses of insulin in a basal insulin to offer people with diabetes the possibility of injecting their basal insulin at anytime of the day with the option to adjust the time of injection.

Ryzodeg® 70/30. the approved brand name for insulin degludec/insulin aspart, contains insulin degludec in a soluble co-formulation with insulin aspart. Ryzodeg® 70/30 can be administered once or twice daily with any main meal. In a ‘treat-to-target’ study supporting the new drug application where Ryzodeg® 70/30 was compared to NovoLog® Mix 70/30, Ryzodeg® 70/30 showed equivalent reductions in HbA1c.

See Link Below:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm464321.htm

 

Cholesterol Study Drug is NOW FDA Approved

July 24, 2015

Sanofi and Regeneron announce the U.S. Food and Drug Administration approved Praluent (alirocumab) Injection, the first PCSK9 Inhibitor in the U.S.,  for the treatment of High LDL Cholesterol in adult patients.  See link below:

http://www.news.sanofi.us/2015-07-24-Sanofi-and-Regeneron-Announce-FDA-Approval-of-Praluent-alirocumab-Injection-the-First-PCSK9-Inhibitor-in-the-U-S-for-the-Treatment-of-High-LDL-Cholesterol-in-Adult-Patients

FDA Approves a Second Drug for Cholesterol

August 27, 2015

The new drug is Repatha™ made by Amgen, and is intended for people with extremely high cholesterol levels and those with heart disease who cannot sufficiently lower their cholesterol levels with statins and other therapies. Repatha will cost $14,100 per year. See links below:

http://www.nytimes.com/2015/08/28/health/fda-approves-another-in-a-new-class-of-cholesterol-drugs.html

https://www.optum.com/thought-leadership/highcostcholesteroldrugs.html

With the cost of these medications going up, its good to know that patients, by volunteering for our clinical trials, actually benefit, by receiving these medications and medical services free, at no cost to the patient.