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Latest From Mallinckrodt plc
Trove Of Opioid Documents May Help Shape Public Health Policy
As sponsors and US FDA continue to face fallout, newly launched digital archive of industry documents from opioid litigation and settlements will be free public resource for those investigating activities that led to the opioid epidemic. It is modeled on the archive of tobacco industry documents, which has been the basis of about 1,000 scientific publications.
Merck & Co.’s Keytruda Stakes Another Adjuvant Flag, In RCC
Adjuvant renal cell carcinoma is a potentially lucrative indication for any checkpoint inhibitor; Merck & Co. flagship Keytruda is the first to demonstrate benefit in a Phase III study, although rivals are in pursuit.
Biden Infrastructure Plan Offers Biopharma R&D Carrot, Tax Stick
Tens of billions would go to fund R&D, including Phase I and Phase II development of vaccines. But the plan would also crack down on inversions and offshoring.
Keeping Track: Recent NDA Submissions Range From Acute Agitation To Von Hippel-Lindau Disease
News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker
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