Government
The U.S. Food and Drug Administration is warning that some drugs that treat hepatitis C can, in rare cases, actually lead to the worsening of liver function or to live failure in patients with chronic hepatitis C.
Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201.
It takes on average five years before the confirmatory trial is even started.
Local Health Departments in Colorado, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Missouri, Nevada, New Hampshire, Ohio, Pennsylvania, Tennessee, and Wisconsin Tell Their Stories
AstraZeneca said the FDA awarded the designation to Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.
Between J&J, Purdue ($270 million), and Israel-based Teva Pharmaceuticals ($85 million), Oklahoma will garner about $927 million – a far cry from the $20 billion the state had been seeking in damages related to the opioid crisis.
Leaders from across the pharmaceutical industry are decrying negative actions taken by government agencies and universities against Chinese researchers in the United States.
Eli Lilly won an arbitration hearing over accusations the Indianapolis-based company misused confidential information regarding the intellectual property of its former business partner, France-based Adocia S.A.
Some have wondered why the agency has hit back at Novartis so hard when the data in question didn’t have any effect on the eventual outcomes of the product’s effectiveness and safety.
The regulatory agency expressed concern regarding the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides, Sarepta said.
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