Removal of FDA Pregnancy Drug Categories: More Harm than Good?

Removal of FDA Pregnancy Drug Categories: More Harm than Good?

Action Points Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. AUSTIN, Texas — Knowing where a particular drug was classified in the FDA’s “pregnancy categories” significantly impacted a clinician’s decision about […]

Bulk Drug Compounders Confounded by FDA Plan

Bulk Drug Compounders Confounded by FDA Plan

Apr 27, 2018 / by The FDA, citing safety, says large-scale drug compounders should use agency-approved drug substances instead of bulk substances whenever possible, but critics say that’s neither necessary nor wise. The FDA’s recently issued draft guidance explaining how it’ll accept nominations for the “503B Bulks List”—approved bulk drug substances that […]

A potential new weapon in the battle against addiction

A potential new weapon in the battle against addiction

Cocaine and other drugs of abuse hijack the natural reward circuits in the brain. In part, that’s why it’s so hard to quit using these substances. Moreover, relapse rates hover between 40 and 60 percent, similar to rates for other chronic conditions like hypertension and Type 1 diabetes. Penn behavioral pharmacologist and neuroscientist Heath Schmidt studies how long-term […]

FDA-approved drugs to treat diabetes and obesity may reduce cocaine relapse and help addicted people break the habit

FDA-approved drugs to treat diabetes and obesity may reduce cocaine relapse and help addicted people break the habit

The green fluorescent ‘dots’ above show where Exendin-4, an FDA-approved drug used to treat diabetes and obesity, ends up in the brain. The drug activates receptors for glucagon-like peptide 1 or GLP-1, a hormone that reduces food intake. The blue and red coloring indicate neurons and astrocytes, respectively. Credit: University of Pennsylvania Cocaine and other […]

Eloxx Pharmaceuticals (ELOX) Says FDA Granted Orphan-Drug Designation for ELX-02 for Treatment of Cystinosis

Eloxx Pharmaceuticals (ELOX) Says FDA Granted Orphan-Drug Designation for ELX-02 for Treatment of Cystinosis

News and research before you hear about it on CNBC and others. Claim your 2-week free trial to StreetInsider Premium here. Eloxx Pharmaceuticals, Inc. (“Eloxx”), (NASDAQ: ELOX), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of […]

No change in FDA's position on Parkinson's drug Nuplazid

No change in FDA's position on Parkinson's drug Nuplazid

Contrary to a CNN report that the FDA is re-examining the Parkinsons’s disease drug Nuplazid, there has been no recent change, according to the regulator and drugmaker Acadia Pharmaceuticals. At issue is whether previously unknown risks have been found for Nuplazid, which treats Parkinson’s disease psychosis. That would be of concern to patients — and […]

Eloxx Pharmaceuticals Announces FDA Grant of Orphan-Drug Designation for Investigational Drug ELX-02 for …

Eloxx Pharmaceuticals Announces FDA Grant of Orphan-Drug Designation for Investigational Drug ELX-02 for …

WALTHAM, Mass., April 27, 2018 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. (“Eloxx”), (NASDAQ:ELOX), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of functional proteins, today announced that it has received orphan-drug designation from the Food and […]

FDA fast tracks IBS-D drug candidate

Biopharmaceutical company OrphoMed announced that the FDA has granted Fast Track status to speed development of its drug candidate for diarrhea-predominant irritable bowel syndrome. ORP-101, a buprenorphine dimer therapeutic, is a peripherally active partial mu opioid receptor agonist and K opioid receptor antagonist designed to ease colonic hypersensitivity stemming from intestinal hyperalgesia and motility dysfunction […]

US FDA panel recommends approval of cannabis-derived drug for the first time

US FDA panel recommends approval of cannabis-derived drug for the first time

US FDA panel recommends approval of cannabis-derived drug for the first time Source: Shutterstock.com Following a US Food and Drug Administration expert panel vote, Epidiolex could become the first prescription cannabidiol in the United States A US Food and Drug Administration (FDA) expert panel has voted in favour of approving the cannabinoid medication Epidiolex (cannabidiol) for the treatment […]