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The FDA has updated its list of planned guidances for the calendar year to include one on evaluating the abuse-deterrent properties of generic solid oral opioid drugs. Read More
Australian drugmakers want the government to create fast-track approval pathways for new cancer drugs, as well as parallel review processes that simultaneously assess safety and efficacy and reimbursement eligibility for new drugs. Read More
The FDA Wednesday approved Actavis’ Avycaz, a new antibiotic for adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections. Read More
The South Carolina Supreme Court more than halved the $327 million in penalties imposed on Johnson & Johnson’s Janssen drug unit by a lower court for hiding the risks of its drug Risperdal, ruling that the penalties levied on the company were excessive. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade – just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More