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 September 1, 2020

9/1/2020

 
Regulatory Update
 
The FDA approved clascoterone cream (Winlevi, Cassiopea), on 8/27/2020, for the treatment of acne in patients 12 years and older. Clascoterone cream is not expected to be available until early 2021.
 
The FDA accepted the NDA for tepotinib for the treatment of metastatic non-small cell lung cancer harboring METex14 skipping alterations. 
 
The FDA notified Tricida that additional clinical data would be required to demonstrate the durability and effect of veverimer on serum bicarbonate and the applicability to patient care.
 
NewAmsterdam Pharma (NAP) acquired the rights to develop and market obicetrapib (AMG 899) from Amgen in August 2020. NAP plans to evaluate obicetrapib in a Phase III cardiovascular outcome trial in 2021.
 
The EU granted conditional approval for imlifidase as a desensitization treatment in highly sensitized kidney transplants patients.
 
Announced Research Updates
 
Novartis announced that in the 24-week, Phase III, ASCEMBL trial, treatment with asciminib produced a superior major molecular response (MMR) rate compared to bosutinib in patients with Philadelphia chromosome-positive chronic myeloid leukemia.
 
Dermavant announced that in the 12-week, 510 patient, Phase III, PSOARING 1 trial, 35.4% of patients treated with tapinarof 1% daily resulted in achievement of the Physician Assessment (PGA) scores of clear or almost clear and at least a 2-point improvement in the PGA score in 35.4% of patients compared to 6% with placebo in patients with plaque psoriasis. Dermavant also announced that in the 12-week, 515 patient, Phase III, PSOARING 2 trial, 40.2% of patients treated with tapinarof 1% daily resulted in achievement of the Physician Assessment (PGA) scores of clear or almost clear and at least a 2-point improvement in the PGA score in 35.4% of patients compared to 6.3% with placebo in patients with plaque psoriasis.
 
Akcea announced that in a 6-month, 114 patient, Phase II, dose-ranging trial, treatment with AKCEA-APOCIII-LRX lowered triglycerides up to 62% and apoC-III up to 74%, while increasing HDL by up to 42% in patients with hypertriglyceridemia who have established cardiovascular disease (CVD) or are at risk for CVD.
 
Published Research Updates
 
In an 84-day, 18 patient, Phase II trial, treatment with emixustat did not improve IL-1beta, IL-6, IL-8, TGFbeta-1, and VEGF in the aqueous humor compared to placebo in patients with proliferative diabetic retinopathy.
 
Only 17.4% of patients completed a 52-week, 161 patient, Phase III, trial evaluating sirukumab in the treatment of giant cell arteritis. Limited data suggested that fewer patients treated with sirukumab developed a flare compared to placebo.
 
In a 128 patient, Phase II trial, veliparib added to cisplatin and etoposide did not differ from only cisplatin and etoposide in patient reported neurotoxicity.


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.