Good morning, everyone, and how are you today? We are doing just fine, thank you, now that the Pharmalot campus has quieted down. One short person has left for gainful employment, the other is sleeping in, and our official mascot is curled in a corner waiting for treats. Such a life, yes? Have no fear. We have treats for you as well — the menu of tidbits assembled below. Along with a cup of stimulation, this can be a fine way to start the day. On that note, we hope you conquer the world and, of course, do keep in touch …
Endo International (ENDP) and Allergan (AGN) are in talks to avoid going to a landmark trial set to begin in October over the opioid crisis, according to the Wall Street Journal. Endo is close to finalizing a $10 million deal, and Allergan is in negotiations for a potential $5 million deal that would settle claims over its branded drugs but may not entirely eliminate it from the trial. The settlements, if finalized, would bring the companies in accord with two Ohio counties whose claims have been chosen to serve as bellwethers in litigation over the opioid crisis.
In a surprising setback for Sarepta Therapeutics (SRPT), the Food and Drug Administration rejected its application for a second drug aimed at treating children with Duchenne muscular dystrophy, a rare muscle-wasting disease, STAT reports. The FDA denied the approval of its drug, called Vyondys 53, due to the risk of infections related to intravenous infusion ports and kidney toxicity seen in animal experiments. Generally, the FDA has issued fast approvals for rare-disease drugs as a way to speed development of medicines for unmet medical needs.
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