Thursday, May 30, 2019

Daily Update - May 30th, 2019

Manuscripts -

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval
JAMA
- Conclusion in summary: A dartboard would an equally effective to with which to designate Accelerated Approval status

ADC Business - 

Drug Giant Tries New Tactic to Fight Cancer
Wall Street Journal
- Jose Baselga is directing AZ to focus on early stage cancer indications.  Its a risky move because early stage is harder to detect, but maybe easier to treat.  This shift might necessitate an early phase diagnostic technique in concert with the therapy

IPO boom: Antibody experts at Genmab outline global ambition in pitch for $500M
Endpoints News
- With a potential $500M payday, and two concurrent projects with SeaGen and a smaller partnership with ADC Therapeutics.  Genmab is looking to become a major player in our space

Zymeworks' Lead Asset, ZW25, Granted Fast Track Designation from the FDA
Zymeworks
- Zymeworks is continuing its run of headline grabbing with a Fast Track Designation on its lead asset

Regulatory - 

COTA and FDA Partner on Real-World Evidence Program in Breast Cancer
Biospace
- The FDA is taking a more wholistic view of cancer therapy with the help of COTA and real-world evidence.  It is attempting to move beyond a single-minded view of Progression Free Survival times

In The Clinic - 

Benefit of Antibody Drug Conjugate T-DM1 in HER2+ BC
TargetedOnc
- Sometimes its easy to forget how directly the ADC space impacts patients.  If that weren't enough, this article proposes that preoperative application of T-DM1 can give indications about how to treat the patient after tumor removal via surgery

Sutro Presents Preliminary Results From Ongoing Phase I Study of STRO-001
ADC Review
- Sutro is announcing the top-line results for their STRO-001 asset at the European Hematology Association conference.  Initial reads look very encouraging.

Beyond the ADC World - 

Trump pushed for the federal right-to-try law. One year later, only two people got treatment
Cincinnati Enquirer
- A perfect example of how a simple fix in the world of pharmaceuticals in anything but...



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