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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.
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.
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.
News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker
- Medical Devices
- Generic Drugs
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
- Aspect Medical Systems, Inc.
- BÂRRX Medical, Inc.
- Cadence Pharmaceuticals, Inc.
- CNS Therapeutics, Inc.
- ev3 Inc.
- Given Imaging Ltd.
- Ikaria Holdings, Inc.
- InfaCare Pharmaceutical Corporation
- INO Therapeutics, LLC
- Mallinckrodt Inc.
- Mallinckrodt Pharmaceuticals
- Micro Therapeutics, Inc.
- Nellcor Puritan Bennett, Inc.
- Ocera Therapeutics Inc. (OCRX)
- Oridion Systems Ltd.
- Questcor Pharmaceuticals, Inc.
- Somanetics Corp.
- Sonorant Inc.
- SpecGx Inc.
- Sucampo Pharmaceuticals, Inc.(SCMP)
- VNUS Medical Technologies
- Stratatech Corporation
- Tranzyme Pharma