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CP Wire Articles

Interview With Hatch-Waxman Expert Kurt Karst

                 
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He... read more

Tue, 04/24/18 - 07:50 pm
Overview of Pfizer's Biosimilar Program

Pfizer received a Complete Response Letter from the FDA on 4/23/18 highlighting the need for additional technical information. Though this is a setback for Pfizer's Herceptin biosimilar program,... read more

Tue, 04/24/18 - 07:43 pm
FDA Approves Otsuka's Jynarque as First Treatment to Kidney Decline in Rapidy Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD)

  • ADPKD, the fourth leading cause of end-stage renal disease,1,2 is a progressively debilitating genetic disease characterized by the development of fluid-filled cysts in the kidneys... read more
Tue, 04/24/18 - 06:59 pm
GSK's Trelegy Ellipta Gains New Indication in the US for the Treatment of Patients With COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced on 4/24/18 that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (... read more

Tue, 04/24/18 - 02:26 pm
Celgene's Ozanimod Reduces Relapses and Brain Volume Loss in MS Patients in Phase III Trials

Celgene Corporation (NASDAQ:CELG) announced  on 4/24/18 additional phase III data analyses evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1... read more

Tue, 04/24/18 - 09:25 am

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