Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
Growth Spurt: Pediatric Labeling Is On The Rise, Taxing US FDA Safety Monitoring
The US FDA Pediatric Advisory Committee uses web-posted reviews of “low safety risk” products to keep up with postmarketing monitoring requirements amid rising interest in pediatric development.
US FDA's Slim October User Fee Calendar Brings Some Controversy
Advisory committee concerns cast clouds over Iterum’s oral antibiotic, Intercept’s Ocaliva, and perioperative immuno-oncology regimens, while CSL and Pfizer aim to take their hematology franchises in new directions.
All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer
Maturing data supporting first-line indications for Merck’s Keytruda, Bristol’s Opdivo and BeiGene’s Tevimbra show inadequate efficacy for patients at the lowest level of PD-L1 expression in esophageal and gastric cancers.
US FDA Revisits PD-L1 Biomarker In Gastric, Esophageal Cancers
The Oncologic Drugs Advisory Committee will discuss restrictions for patients expressing PD-L1 in first-line labeling for Merck’s Keytruda, Bristol Myers Squibb’s Opdivo, and a pending NDA for BeiGene’s Tevimbra.
Evergreen With Envy: Halozyme’s Subcutaneous Conversions Grow As Rivals Hope To Break In
Halozyme’s Enhanze technology has now brought seven monoclonal antibodies, including Ocrevus and Tecentriq, from IV to subcutaneous delivery, but Alteogen and other high-concentration formulation players hope to join the party as Medicare pricing issues help drive interest.
Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency
Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.