Several biopharmaceutical companies submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration in recent weeks, covering treatment indications ranging from an opioid overdose to bipolar disorder and rare disease.
The U.S. Food and Drug Administration issued a Complete Response Letter for Alkermes’ New Drug Application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and bipolar 1 disorder, and a CRL for Adamis Pharmaceuticals’ NDA for the high-dose naloxone injection product ZIMHI for the treatment of opioid overdose.
The U.S. Food and Drug Administration declined to approve Adamis Pharmaceuticals Corp.’s opioid overdose treatment Zimhi, sending the company’s shares plunging 56 percent.
The U.S. Department of Health and Human Services will offer states more than $1.8 billion in new funding to fight the opioid epidemic.
Less than a month after filing for bankruptcy, Insys Therapeutics gained a reprieve from some lawsuits as well as a path forward for regulatory approval of an opioid overdose treatment.
Oklahoma Attorney General Mike Hunter’s $17 billion lawsuit is the first to go to trial of more than 2,000 actions by state and local governments accusing opioid manufacturers of contributing to an epidemic linked to a record 47,600 overdose deaths in 2017, according to the U.S. Centers for Disease Control and Prevention.
Privately held pharmaceutical company Wraser Pharmaceuticals announced the publication of a White Paper addressing opioid safety.
Generic drugmaker Teva Pharmaceutical Industries Ltd. received approval from the U.S. Food and Drug Administration to market the company’ generic nasal spray for opioid overdose.
As the United States continues to grapple with the opioid epidemic, researchers have developed a new test that can measure pain biomarkers in the blood.
Researchers are reporting a link between doctor-targeted marketing of opioid products and the increase in U.S. deaths from overdoses.