Prescribe Right
Prescribe Right
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
Pipeline News and Updates
Picture

Update for the Week Ending April 4, 2020

4/7/2020

 
Regulatory Update
 
The FDA accepted the BLA for remestemcel-L for the treatment of children with steroid-refractory acute graft versus host disease and set a PDUFA date of 9/30/2020. Remestemcel-L is approved as Temcell in Japan.
 
Blueprint completed a rolling NDA submission for pralsetinib for the treatment of RET fusion-positive non-small cell lung cancer. 
 
Rhythm completed a rolling submission for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
 
BMS and Celgene submitted a BLA for idecabtagene vicleucel for the treatment of refractory multiple myeloma.
 
Announced Research Updates
 
Verona announced that in a 40 patient, Phase II, open-label trial, treatment with ensifentrine pressurized metered-dose inhaler increased FEV1 47 mL to 391 mL with doses of 300 mcg to 6000 mcg dose, in patients with moderate to severe COPD.
 
Published Research Updates
 
In a 24-week, 849 patient, Phase III trial, patients treated with tanezumab 5 mg had a greater decrease in the WOMAC pain and physical function scores and the Patient’s Global Assessment of OA (PGA-OA) compared to placebo in patients with osteoarthritis. The 2.5 mg dose of tanezumab had a a greater decrease in the WOMAC pain and physical function scores, but not the PGA-OA compared to placebo. 
 
In the 60 patient, Phase II, open-label, ZUMA 2 trial, a single infusion of KTE-X19 resulted in an overall response rate of 93% in patients with relapsed or refractory mantle cell lymphoma. 
 
In a 24-hour, 151 patient, Phase III, Japanese-registered trial, 55% of patients treated with landiolol achieved a heart rate of 60-94 bpm compared to 33% in the placebo group in patients with sepsis-related tachyarrhythmia.


Comments are closed.
    Stay informed, subscribe to the 
    ​
    Prescribe Right Pharmaceutical Pipeline Tracker
    Latest Tweets from Prescribe Right

    Archives

    January 2023
    December 2022
    October 2022
    September 2022
    August 2022
    July 2022
    June 2022
    May 2022
    April 2022
    March 2022
    February 2022
    January 2022
    December 2021
    November 2021
    October 2021
    September 2021
    August 2021
    July 2021
    June 2021
    May 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    February 2020
    January 2020
    December 2019
    November 2019
    October 2019
    September 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    June 2018
    May 2018
    April 2018
    March 2018
    February 2018
    January 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    August 2015

    RSS Feed

Services

Pharmaceutical Pipeline Tracker​
Consulting

Company

About
Blog
Tweets

Support

Contact
© COPYRIGHT 2015. ALL RIGHTS RESERVED.