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

Investigational Update for the Week Ending 6 April 2019

4/9/2019

 
The FDA accepted the NDA for Kyowa Hakko Kirin’s istradefylline in April 2019 and set a PDUFA date of 8/27/2019. Istradefylline is an A2A antagonist seeking approval for the treatment of Parkinson's Disease wearing-off phenomenon in patients on levodopa therapy.
 
The FDA delayed the PDUFA date for Ambit Biosciences Corporation/Daiichi Sankyo’s quizartinib from May to August 2019. This KIT Inhibitor targets acute myeloid leukemia.
 
The FDA granted AstraZeneca’s selumetinib Breakthrough Therapy status. The drug is a MEK Inhibitor targeting differentiated thyroid cancer.
 
The EMA accepted the MAA for Daiichi Sankyo/Plexxikon’s pexidartinib in April 2019. It’s a CSF-1R inhibitor targeting Giant cell tumors of the tendon sheath.
 
Shionogi submitted an MAA for cefiderocol in April 2019.

Immunocore’s IMCgp100 has been assigned the generic name tebentafusp and has both Fast Track and Orphan status. The drug is seeking approval for the treatment of uveal melanoma. It’s an ImmTAC which binds to cancer cells with peptide-HLA. This brings circulating T cells to the tumor site, which releases killing lytic granules, that kill the cancer cell.
 
AZ announced interim results from two cohorts of patients in the Phase Ib, TATTON trial:
  • In a 46 cohort of patients with EGFR-mutant lung cancer with acquired resistance driven by MET amplification after treatment with a first- or second-generation EGFR TKI and negative for T790M mutation treatment with savolitinibin in combination with osimertinib resulted in an objective response rate (ORR) of 52%, with 24 partial responses. 
  • In the second cohort of 48patients with EGFR-mutant lung cancer with acquired resistance driven by MET amplification after treatment with osimertinib or another experimental third-generation EGFR TKI treatment with savolitinibin in combination with osimertinib resulted in an ORR of 28% percent, with 12 partial responses.
 
An analysis of data in two phase 3 trials for Nektar’s NKTR-181, using the MADDERS system, show a low withdrawal rate and a low risk of abuse potential, diversion or addiction.

Syndax announced that an interim analysis from 53 patients with progressing melanoma on prior PD-1 blockade in a cohort of the Phase Ib/II ENCORE 601 trial, treatment with entinostat and pembrolizumab resulted in an objective response in 19% of patients and progression-free survival of 4.2 months.

Allergan announced that in the 123 patient, 28 week, Phase III, open label MAPLE trial, the incidence of intraocular inflammation with a new formulation of abicipar given every two months was 8.9%. The rate of intraocular inflammation in the MAPLE trial was lower than the 15.1 to 15.7% see in the Phase III CEDAR and SEQUOIA trials. The rate of intraocular inflammation is reported as 0.01% with aflibercept, 0 to 0.6% with ranibizumab and 3-55 with brolucizumab. Allergan plans to file a BLA for abicipar in June 2019.

Scynexis’ SCY-078 has been assigned the generic name Ibrexafungerp.

Tonix has an ongoing Phase III trial evaluating cyclobenzaprine for the treatment of fibromyalgia.

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.