Abilify Lawsuits Set for First Trials in June
The first trial in multi-district litigation over claims the antipsychotic drug Abilify caused compulsive behavior must proceed in June, a federal judge has ruled. Source: Drug Industry Daily
E&C Committee Members Propose Overhaul of OTC Monograph System
A bipartisan group of members of the House Energy and Commerce Committee introduced new legislation to reform the FDA’s monograph system for over-the-counter ingredients and replace the agency’s rulemaking process…
FDA Postpones Enforcement of Combination Product Rules, Outlines Requirements for Constituent Parts
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Source: Drug…
AstraZeneca Shows Off New Farxiga Data for Diabetes Patients with Chronic Kidney Disease
AstraZeneca’s drug Farxiga could receive a new indication for a subset of diabetes patients based on Phase III data that was released today. Source: BioSpace
FDA Grants Priority Review for Prostrate Cancer Treatment
The FDA granted a Priority Review designation to Pfizer and partner Astellas Pharma for expanded use of Xtandi in prostrate cancer treatment. Source: BioSpace
Can Gilead Develop a Cure for HIV?
Gilead Sciences essentially created a cure for hepatitis C and may be well on its way to developing a cure for HIV-AIDS. Source: BioSpace
Arena Pharmaceuticals Shares Explode on Positive Ulcerative Colitis Trial Data
Arena Pharmaceuticals released positive top-line results from its Phase II trial of etrasimod in ulcerative colitis. Source: BioSpace
Ocugen's Dry Eye Treatment Hit Its Primary Endpoint
Ocugen announced this morning that its mid-stage combination treatment hit its primary endpoint of tolerability in a proof-of-concept trial. Source: BioSpace
FDA Releases First Clinical Study Summary in New Transparency Pilot
The FDA issued the first clinical trial summary in its pilot program aimed at highlighting key information from pivotal trials of newly-approved drugs. Source: Drug Industry Daily
U.S. Attorney Charges Five Doctors With Taking Bribes, Kickbacks From Insys to Prescribe Fentanyl
Five Manhattan doctors accepted kickbacks and bribes from Insys to prescribe its fentanyl products, according to the U.S. Attorney for the Southern District of New York. Source: Drug Industry Daily
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