Friday, July 12, 2019

Update - July 12th 2019

Regulatory -

Fast-Track Drug Approval, Designed for Emergencies, Is Now Routine
Wall Street Journal
- Don't look now, but as we reported earlier, the Wall Street Journal has noticed that Fast-Track designation doesn't mean all that its cracked up to

The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews
Endpoints News
- When the FDA speaks we should listen.  Janet Woodcock speaks with SVB Leerink about regulatory changes that are coming down the pike.  Well worth a read

The hits keep coming: Apotex loses 31 drug approvals after FDA cites plants for 'inadequate' controls
- I am reminded of the phrase, "if you think you own your house, try not paying your property taxes and see what happens."  CDMO choice matters, and a thorough, and regular QA review is mandatory for the continued success of your operation.  Need more proof, here is another eerily similar story:
Warning letter faults Akorn management for plant failures
-Metal shavings in your lidocaine?  That can't be good

Industry -

WuXi AppTec raising U.S. profile to counter political attacks
- In the wake of a lot of bad press about Chinese companies, WuXi is trying to fight back

US Patent Application
- Merck has a significant ADC portfolio growing in their European group, and clearly they are also interested in building a suite of patented conjugation technologies for further optimize these constructs

ADC Therapeutics has raised $550M-plus in its quest for their first BLA — and here’s why that’s important
Endpoints News
- Looking at clinical results is an important but lagging indicator.  If you want to know who is going to make waves in the near future, look at who is raising money.  And time and again, that seems to be ADC T

Manuscripts -

Synthesis and evaluation of pyrrolobenzodiazepine dimer antibody-drug conjugates with dual β-glucuronide and dipeptide triggers
European Journal of Medicinal Chemistry
- If the therapeutic window of PBDs is too small, then masking could be a viable option to move forward with

Abstract 4743: Using genome-wide CRISPR screen to understand resistance mechanisms to PCA062, a P-cadherin targeting antibody-drug conjugate
AACR Cancer Research
- This is a pretty cool approach to use CRISPR in order to understand the mechanism behind differential effectiveness of ADC therapies.  They were able to identify a drug resistance pathway contributing to ADC resistance

IMGC936, a first in-class ADAM9-targeting antibody-drug conjugate, demonstrates promising anti-tumor activity
- Here is a new target that Immunogen and Macrogenics are looking at.  The question is, how will this be affected by the shakeup currently going on at Immunogen

Thats it for today. There are always more coming down the pike. Is there something I missed? Contact me. [email protected]
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