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Good morning, everyone, and how are you today? We are doing just fine, thank you, despite the changes brought by the end of the vacation season. Our shortest person is back in the local schoolhouse and other short one is gainfully employed. All of which makes the Pharmalot campus a quieter place. This calls for a celebratory cup of stimulation — butter pecan is our newest choice for those tracking such things. Meanwhile, we must prepare for a panel engagement. So time to get cracking. Here are some tidbits as you start the day. Best of luck and keep in touch …

Bayer (BAYRY) is considering job cuts and outsourcing as part of a wide-ranging review of drug research and development that will last until at least November, according to Reuters. The savings would give it financial wiggle room as it competes with larger rivals to buy the right to promising treatments from biotech firms. Bayer is under pressure from investors to make purchases or do licensing deals that they say are needed to ensure the long-term independence of the pharmaceutical division.


With two months of data outstanding, the Food and Drug Administration is on pace to approve a record number of generic drugs in fiscal year 2018, Regulatory Focus informs us. The agency has approved 666 generics in the fiscal year through July and has tentatively approved another 162. With an average of 67 approvals and 16 tentative approvals each month this year, the FDA will likely top its record-setting performance in fiscal year 2017, when 937 generics were approved or tentatively approved.

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  • An appropriately ominous number – “The agency has approved 666 generics in the fiscal year through July….” Sounds like the OGD reviewers are having ‘one hell of a good time’ this year. But Commissioner Scott G will be pleased, I’m sure.

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