The FDA has approved Novimmune SA’s Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is…
Top Clinical Research Organizations at a Glance!
Clinical Research would be a lot more difficult without the help of Clinical Research Organizations (CROs). These companies within the pharmaceutical industry not only help support drug companies but also companies in the biotechnology and medical device industries as well. Some…
A phase 3 study for chikungunya vaccine after passing midstage test
The chikungunya vaccine, known as MV-CHIK, hit its primary goal in the phase 2 trial, and Themis is now eyeing a move into phase 3. The company based its chikungunya shot on its measles vector platform, licensed from Institut Pasteur. In the…
Researchers Use Genetics to Predict Response to Antipsychotic Medications
Genetics can be used to predict a patient’s response to Antipsychotic Medications treatment for schizophrenia, according to a recent study by investigators at The Feinstein Institute for Medical Research. The findings were published online in the American Journal of Psychiatry.Schizophrenia is one…
More than 90% of the world’s children breathe toxic air every day
Every day around 93% of the world’s children under the age of 15 years (1.8 billion children) breathe air that is so polluted it puts their health and development at serious risk. Tragically, many of them die: WHO estimates that in…
Bijuva Becomes First FDA-Approved Hormone Therapy for the Treatment of Hot Flashes
TherapeuticsMD, Inc., a women’s healthcare company, has received FDA approval for Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe…
A new way to prevent heart disease in Type 1 diabetes
Scientists reveal the mechanism which allows a commonly prescribed drug for Type 2 diabetes to prevent heart disease in patients with Type 1 diabetes and could lead to new treatments. Metformin is an inexpensive treatment that is often used for Type…
FDA approves new drug to treat influenza
Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for a Flu treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This is the…
800,000 people kill themselves every year. What can we do?
By the time you finish reading this, at least six people will have killed themselves around the world. Those six are a tiny fraction of the 800,000 people who will kill themselves this year – more than the population of Washington DC,…
AbbVie Resolves Humira Patent Disputes with Sandoz
AbbVie and Novartis’ Sandoz unit reached a global resolution of all intellectual property-related litigation over Sandoz’s proposed biosimilar Hyrimoz for the reference drug Humira (adalimumab). Under the terms of the settlement, AbbVie has granted Sandoz a non-exclusive license to intellectual property relating to Humira beginning…