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

Weekly Update for the Week Ending October 26, 2019

10/28/2019

 
Regulatory Update
 
The FDA approved the combination of elexacaftor, ivacaftor, and tezacaftor (Trikafta, Vertex Pharmaceuticals) on October 21 for the treatment of patients age 12 years or older with cystic fibrosis (CF) and at least one F508del mutation in the CF transmembrane conductance regulator (CFTR) gene. The combination was approved almost 6 months early (3/19/2020 PDUFA date).
 
Ascendis plans to file a BLA for TransCon hGH in the first half of 2020 and an MAA in in the second half of 2020 to treat pediatric growth hormone deficiency. TransCon hGH was designated an Orphan drug by the EMA.
 
The EMA has granted teplizumab PRIME status for the prevention or delay of clinical type 1 diabetes
 
Announced Research Updates
 
Reata announced that in the 48-week, 103 patient Phase II, MOXIe trial, patients treated with omaveloxoloneimproved the modified Friedreich ataxia Rating Scale by 1.55 points compared to a worsening of 0.85 points with placebo in patients with Friedreich ataxia.
 
In March Biogen announced that an interim analysis of the Phase III ENGAGE and EMERGE trials found a low likelihood that aducanumab would improve or slow cognition in Alzheimer’s patients, so Biogen discontinued both trials in March 2019. Biogen analyzed additional data from 3,285 patients and found an improvement in 547 patients enrolled in EMERGE that received the highest dose of the drug. Aducanumab reduced the decline in CDR-SB (23%), MMSE (15%), ADAS-Cog 13 (27%) and ADCS-ADL-MCI (40%). The expanded cohort of high dose patients in ENGAGE did not demonstrate an improvement compared to placebo.
 
Novartis announced that in two 12-week, 700 patient Phase III trials (ZEAL 1 and ZEAL 2), treatment with fevipiprant did not improve FEV1 compared to placebo in patients with moderate asthma. Fevipiprant is being evaluated in preventing exacerbation in moderate to severe asthma in the Phase III LUSTER 1 and 2 trials.
 
Protalix announced interim results from 16 patients in the 12-month, 22 patient, Phase III, open-label BRIDGE trial, showed a decline in eGFR from -5.10 mL/min/1.73m2 per year on stable doses of agalsidase alfa to -0.23 mL/min/1.73m2 per year on pegunigalsidase. Protalix plans to submit a BLA for pegunigalsidase in 1Q20.

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.