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 January 25, 2020

1/28/2020

 
Regulatory Update
 
The FDA approved teprotumumab (Tepezza, Horizon Therapeutics) on 1/21/2020, for the treatment of thyroid eye disease. Horizon has set WAC for teprotumumab at $14,900 per vial. A full 6-month course of treatment will require 23 vials for a total treatment WAC of $343,000 and an estimated price after discount of $200,000. Teprotumumab was approved 6 weeks early. The original PDUFA date was 3/8/2020.
 
The FDA approved tazemetostat (Tazverik, Epizyme) on 1/23/20, for the treatment of metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Tazemetostat is given orally twice a day. Epizyme set WAC at $15,500 for a one-month supply of tazemetostat.
 
GlaxoSmithKline’s belantamab mafodotin was granted a priority review for the treatment of heavily pre-treated patients with relapsed or refractory multiple myeloma. The drug has a projected summer 2020 PDUFA date.
 
The FDA designated AstraZeneca’s tremelimumab an Orphan Drug when given in combination with durvalumab for the treatment of hepatocellular carcinoma.
 
GlaxoSmithKline licensed the M72/AS01E tuberculosis vaccine to the Bill & Melinda Gates Medical Research Institute (MRI). Gates MRI will assume responsibility for development of the vaccine for use in low-income countries with high TB rates.
 
Announced Research Updates
 
Roche announced that in the 12-month, 41 patient, Phase III open-label FIREFISH trial, treatment with risdiplam increased the number of infants sitting without support for at least five seconds, assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III) in patients with Type 1 spinal muscular atrophy.
 
BeiGene announced interim results from a 360 patient, open-label, Phase III trial, in which progression-free survival was improved in patients treated with tislelizumab plus paclitaxel and carboplatin or tislelizumab plus nab-paclitaxel and carboplatin compared to paclitaxel and carboplatin alone in patients with squamous non-small cell lung cancer.
 
Ipsen paused two fibrodysplasia ossificans progressiva (FOP) studies when an independent data monitoring committee concluded the current protocol was unlikely to achieve its objective and the protocol and efficacy analysis may need to be modified.
 
Halozyme announced that in a 494 patient, Phase III trial, treatment with pegvorhyaluronidase alfa plus gemcitabine and nab-paclitaxel did not improve overall survival compared to gemcitabine and nab-paclitaxel (11.2 months vs 11.5 months) alone in patients with metastatic, hyaluronan-high pancreatic ductal adenocarcinoma.
 
Published Research Updates
 
In a 50 patient, Phase II trial, veliparib added to cisplatin and gemcitabine did not improve the response rate compared to cisplatin and gemcitabine alone in patients with BRCA/PALB2+ pancreatic ductal adenocarcinomas.


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.