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

March 17th, 2020

3/17/2020

 
Regulatory Update
 
The FDA accepted the NDA for Athenex/Almirall’s tirbanibulin for the treatment of actinic keratosis and set a PDUFA date of 12/30/2020.
 
The FDA designated F2G’s olorofim as an Orphan Drug for the treatment of invasive aspergillosis and lomentospora/scedosporium infections.
 
Announced Research Updates 
 
ORMD announced that in a 12-week, 269 patient, Phase IIb dose-ranging trial, treatment with oral insulin reduced HbA1c by 0.6% with 32 mg once daily and twice daily compared to placebo in patients with type 2 diabetes receiving metformin with up to two additional oral antihyperglycemic agents. Giving the dose three times per day did not improve HbA1c more than placebo.
 
AZ announced that in a Phase III, open-label trial, treatment with cediranib plus olaparib did not improve progression-free survival compared to platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer.
 
Published Research Updates
 
In the 48-week, 877 patient, Phase III, STELLAR-4 trial, treatment with selonsertib 18 mg or 6 mg did not improve liver fibrosis by one stage or more without disease worsening compared to placebo (10-12% vs 13%) in patients with compensated cirrhosis due to NASH. In the 48-week, 803 patient, Phase III, STELLAR-3 trial, treatment with selonsertib 18 mg or 6 mg did not improve liver fibrosis by one stage or more without disease worsening compared to placebo (13-14% vs 13%) in patients with stage 3 fibrosis from NASH.
 
In the 14-week, 610 patient, Phase III, open-label, SUMMIT-07 trial, loxicodegol exhibited a low rate and severity of opioid withdrawal compared to placebo as measured by Clinical Opiate Withdrawal Scale (COWS) - 2.3% vs .05%; Subjective Opiate Withdrawal Scale (SOWS) - no difference; Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS) - 2.9% vs 3.7% in patients with chronic low back pain.
 
In a 48-week, 40 patient, Phase II trial, patients with chronic HBV who tested HBV e-antigen negative were treated for 48 weeks with tenofovir disoproxil fumarate, pegylated interferon alfa-2a and either REP 2139 or REP 2165. The two investigational drugs were equivalent in efficacy. At 48 weeks HBsAg levels were 0.05 IU/mL or lower in 24/40 patients. 48 weeks after the end of treatment virologic control persisted in 13/40 participants.
 
In a 115 patient, Phase II trial, trebananib plus bevacizumab had a worse 6-month PFS compared to bevacizumab monotherapy in patients with recurrent glioblastoma.
 
In a 234 patient, Phase II trial, treatment with olanzapine plus samidorphan did not reduce the time to the first event of exacerbation of disease symptoms compared to olanzapine monotherapy in patients with schizophrenia and alcohol use disorder.
 
A 22.7 month interim analysis of data from 843 patients participating in a Phase III, extension, open-label trial, showed that treatment with peficitinib resulted in ACR20/50/70 in 78.9%, 61.4%, and 42.7% of Asian patients with rheumatoid arthritis.

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.