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TXT Foreign Study Sites Escape FDA Oversight: Professor [609 Words] [ Price : $8.95]
A Journal of Clinical Pharmacology study finds that FDA has less oversight of overseas clinical trials that are used to form the basis of approval for drugs in the U.S. than it does for domestically conducted trials.
11/12/2021
 
 
TXT PharmaEssentia BLA Approved for Blood Disease [338 Words] [ Price : $8.95]
FDA approves a PharmaEssentia BLA for Besremi injection to treat adults with polycythemia vera, a blood disease associated with red blood cell overproduction.
11/12/2021
 
 
TXT Novavax Expects U.S. Covid Vaccine Filing Soon [2625 Words] [ Price : $8.95]
Novavax requests a meeting with FDA in advance of filing for approval of its Covid-19 vaccine.
11/11/2021
 
 
TXT PureTech Orphan Status for Pancreatic Cancer Drug [189 Words] [ Price : $8.95]
FDA grants PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer.
11/11/2021
 
 
TXT Topline Data Confirm Semorinemab Effect on Alzheimer’s [2719 Words] [ Price : $8.95]
Data presented by Genentech show AC Immune’s semorinemab reduced cognitive decline compared to placebo in a Phase 2 Alzheimer’s disease trial.
11/11/2021
 
 
TXT Don’t Approve Eagle Vasostrict ANDA Yet: Par [2754 Words] [ Price : $8.95]
Par asks FDA not to approve an Eagle ANDA referencing Vasostrict until specified changes are made regarding the pH specification.
11/11/2021
 
 
TXT Oklahoma Court Overturns J&J Opioid Case Ruling [2858 Words] [ Price : $8.95]
The Oklahoma Supreme Court says a lower court erred in determining that J&J violated the state’s public nuisance law in the way it marketed prescription opioids.
11/11/2021
 
 
TXT Rivoceranib Gets Orphan Status for Liver Cancer [113 Words] [ Price : $8.95]
FDA grants Elevar Therapeutics an orphan drug designation for rivoceranib and its use for treating hepatocellular carcinoma.
11/11/2021
 
 
TXT FDA Accepts Jardiance sNDA for CV Risk Reduction [126 Words] [ Price : $8.95]
FDA accepts for priority review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovascular death plus hospitalization for certain adults with heart failure.
11/11/2021
 
 
TXT Naviswiss Hip Replacement Navigator Cleared [78 Words] [ Price : $8.95]
FDA clears a Naviswiss 510(k) for its Naviplan, a digital pre-operative planning application to assist orthopedic surgeons in performing navigated total hip replacement surgery.
11/11/2021
 
 
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