Good morning, everyone, and how are you today? We are doing just fine, thank you, despite cloudy skies looming over the Pharmalot campus. After all, the birds are still chirping and a cool breeze is wafting by. Moreover, this marks the middle of the week, which means we have managed to survive this far. Speaking of survival, we will be off for a couple of days, so a colleague will fill in for us. Meanwhile, here are some tidbits. Have a grand day and see you next week …
Although studies indicated a Roche (RHO5) cancer drug called Rituxan may suitably treat multiple sclerosis, the company never pursued this option because the patent was due to expire, but the company will still profit substantially, Bloomberg News writes. Why? Instead, Roche tweaked the drug and created Ocrevus, which took years to reach patients and costs $65,000 a year, while Rituxan costs about $8,000 to $10,000 in the U.S. for patients who can get it prescribed for MS.
Amazing. If you graduated this year from my dad’s med school it cost $350,000 for four years. You may be administering a drug costing $650,000. I just wonder who is going to come up with the $1,000,000 for the MD degree and the drug.
For Bicoya Cosmetics “among other things” includes the new regulatory juggernaut – data integrity. From #4 – “In addition, analytical testing records were missing data, dates, and signatures. Our investigator observed your staff altering information in analytical test reports during the inspection. For example, you significantly altered the analytical testing report for (b)(4) Ointment lot (b)(4), although this lot had already been distributed to the U.S. market.”
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