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
  • 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
  • Contact Us
Pipeline News and Updates
Picture

Six Drugs Added to Knowledgebase

8/22/2022

 
We recently added six new drugs to the knowledgebase:
  • Exebacase an antistaphylococcal lysin for the treatment of complicated S. aureus bacteremia is being developed by ContraFect
  • Treosulfan an alkylating agent for the treatment of allogeneic hematopoietic stem cell transplantation (allo-HSCT) is being developed by Medexus Pharmaceuticals and Medac
  • Litifilimab an anti-BDCA2 antibody for the treatment of lupus erythematosus and cutaneous lupus erythematosus is being developed by Biogen
  • Garadacimab a factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) for the treatment of hereditary angioedema (HAE) is being developed by CSL
  • Fesomersen an antisense drug for the treatment of thrombosis prophylaxis is being developed by Ionis Pharmaceuticals and Bayer
  • Aumolertinib an EGFR-tyrosine kinase inhibitor for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC) is being developed by EQRx and Jiangsu Hansoh Pharmaceutical
The Prescribe Right Pharmaceutical Pipeline Tracker now allows you to track 1,060 investigational and recently approved drugs supported by 2,716 announced and published study results.

Update for August 11, 2022

8/10/2022

 
Regulatory Update
 
The FDA accepted the NDA for donanemab for the treatment of Alzheimer’s disease and set a PDUFA date for 1Q2023
 
The FDA informed Travere that interim data from the 404 patient, Phase III DUPLEX trial was not enough to support approval of sparsentan. Final data from the DUPLEX trial will be available in the first half of 2023 with a projected NDA submission by the end of the year if the data is positive.
 
The FDA extended PDUFA date for omaveloxolone by three months to allow additional time to review newly submitted data. The new PDUFA date is 2/28/2023.
 
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 9/22/2022, to review the BLA for RBX2660 to reduce recurrent C. difficile infection after antibiotic treatment.
 
Announced Research Updates
 
Ambit Biosciences announced that in a 10 patient, Phase I/II trial, 90% of patients treated with quizartinib plus azacitidine achieved a complete response in patients with myelodysplastic syndrome and myelodysplastic syndrome/myeloproliferative neoplasms whose tumors harbored FLT3 or CBL mutations. After a median of 13.2 months, only one patient remained on quizartinib and azacitidine.
 
Karuna announced that in the five-week, 252 patient, Phase III, EMERGENT-2 trial, treatment with xanomeline and trospium decreased the total PANSS score by 9.6 points compared to placebo in patients with schizophrenia who were experiencing acute psychosis.
 
AstraZeneca announced that in the 193 patient, Phase II, SAVANNAH trial, treatment with osimertinib plus savolitinib resulted in a 32% ORR in patients with mutated EGFR NSCLC and MET over expression. The ORR was 49% in 108 NSCLC patients with high levels of MET.
 
Hutchmed announced that in the 691 patient, Phase III, FRESCO-2 trial, treatment with fruquintinib improved OS compared to placebo in patients with advanced, refractory metastatic colorectal cancer.
 
CStone announced interim data from the Phase III, GEMSTONE-301 trial, where patients treated with sugemalimab achieved progression-free survival of 10.5 months compared to 6.2 months with placebo in patients with locally advanced/unresectable Stage III squamous non-small cell lung cancer (NSCLC) without disease progression after concurrent or sequential chemoradiotherapy.
 
BeiGene announced that in the 674 patient, Phase III, RATIONALE 301 trial, overall survival with tislelizumab was non-inferior to sorafenib in patients with unresectable hepatocellular carcinoma.
 
Verona announced that in the 12-week, 789 patient, Phase III, ENHANCE-2 trial, treatment with ensifentrineincreased FEV1 by 94 mL compared to placebo in patients with chronic obstructive pulmonary disease.
 
Daiichi Sankyo and AstraZeneca announced interim data from 75 patients with previously untreated or pretreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations enrolled in the open-label, Phase Ib, TROPION-Lung02 trial. The ORR for 38 patients treated with datopotamab deruxtecan in combination with pembrolizumab was 37% and when platinum chemotherapy was added to the two drugs the ORR was 41% in 37 patients.
 
Kazia announced interim results from nine patients in the 12-patient, initial exploratory stage of a Phase I trial, where adding paxalisib to radiotherapy resulted in a 100% overall response rate (ORR) compared to a historical ORR for radiotherapy alone of 20% to 45% in patients with brain metastases.
 
Cornerstone announced that in a 20 patient, Phase Ib trial, treatment with devimistat plus gemcitabine and cisplatin resulted in an overall response rate of 45% in patients with locally advanced unresectable or metastatic biliary tract cancer.
 
Published Research Updates
 
In a revised report, ICER found evidence to support efficacy for AMX0035 in the treatment of amyotrophic lateral sclerosis (ALS) to be comparable or better compared to standard of care alone. If AMX0035 is priced similar to intravenous edaravone at $171,000 a year, the drug would exceed cost effectiveness thresholds. ICER calculated an annual health-benefit price benchmark (HBPB) range for AMX0035 of $9,100 – $30,600.
 
In a 12-week, 52 patient, Phase II trial, treatment with cilofexor resulted in a 21% decrease in serum alkaline phosphatase (ALP), 30% decrease in gamma-glutamyl transferase (GGT), 49% decrease in alanine aminotransferase (ALT), and 42% decrease in aspartate aminotransferase (AST) compared to placebo in patients with primary sclerosing cholangitis. In a 96-week, 47 patient, open-label extension of the Phase II trial, liver biochemistry and biomarkers increased during a four-week period with no drug.  The values then decreased when back on cilofexor for the 96-week extension by 8.3% for ALP, 29.8% for GGT, 29.8% for ALT, and 16.7% for AST.
 
In a 12-week, 57 patient, Phase II trial, treatment with durvalumab and tremelimumab, followed by durvalumab alone resulted in progression-free survival of 49% in patient with advanced or metastatic sarcoma.
 
In the six-month, 400 patient, Phase III, ST PETER HIV trial, adding varenicline or cytisine to nicotine replacement therapy (NRT) did not decrease risky drinking and smoking compared to NRT alone in HIV patients who engage in risky drinking and smoking.

Update for August 4, 2022

8/4/2022

 
Regulatory Update
 
The FDA accepted the NDA for tofersen to treat superoxide dismutase 1 amyotrophic lateral sclerosis (SOD1-ALS) and set a PDUFA date for 1/25/2023.
 
The FDA accepted the NDA for sotagliflozin for the treatment of heart failure and set a PDUFA date for 6/27/2023.
 
The FDA accepted the BLA for the combination of N-803 plus Bacillus Calmette-Guerin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder carcinoma and set a PDUFA date for 5/23/2023.
 
The FDA accepted the BLA for omidubicel for the treatment hematologic malignancies progressing to allogenic hematopoietic stem cell transplant (HSCT) and set a PDUFA date for 1/30/2023.
 
Cidara submitted an NDA for rezafungin for the treatment of candidemia and invasive candidiasis.
 
Sarepta plans to submit a BLA for delandistrogene moxeparvovec for the treatment of ambulant Duchenne muscular dystrophy in the second half of 2022.
 
MHRA granted marketing authorization for voxelotor for the treatment of hemolytic anemia due to sickle cell disease.
 
ObsEva discontinued development of linzagolix and returned development and marketing rights back to Kissei after the FDA indicated that additional data was required to address NDA deficiencies.
 
CHMP granted an accelerated assessment for leniolisib for the treatment of PI3K delta syndrome.
 
Announced Research Updates
 
J&J announced that in the 20 patient, open-label, Phase 1b/2 CHRYSALIS-2 trial, treatment with lazertinib, amivantamab, carboplatin and pemetrexed resulted in an overall response rate (ORR) of 50% in patients with relapsed/refractory non-small cell lung cancer (NSCLC) and EGFR mutations.
 
AstraZeneca has discontinued development of adavosertib as a treatment for ovarian cancer, solid tumors and uterine serous cancer.
 
Novo announced that in the 26-week, 588 patent, Phase IIIa, ONWARDS 3 trial, once-weekly insulin icodec lowered HbA1c 1.57% compared to a 1.36% decrease with once-daily insulin degludec in patients with type 2 diabetes who were insulin-naive. Novo announced that in the 26-week, 588 patent, Phase IIIa, ONWARDS 4 trial, once-weekly insulin icodec lowered HbA1c 1.16% compared to a 1.18% decrease with once-daily insulin glargine in patients with type 2 diabetes who were also receiving mealtime insulin aspart two to four times daily.
 
Immutep announced that in the 36 patient, Part B of the Phase II, open-label TACTI-002 trial, treatment with eftilagimod alpha plus pembrolizumab resulted in overall survival of 9.7 months in patients with second line checkpoint inhibitor refractory metastatic NSCLC.
 
Concert announced that in a 24-week, 517 patients, Phase III, THRIVE-AA2 trial, treatment with CTP-543 resulted in achievement of a SALT score of 20 or less in 38.3% of patients treated with 12 mg and 33% who received 8 mg compared to 0.8% with placebo in patients with moderate to severe alopecia areata.
 
The results of two failed CNTX-4975 trials have not been announced, presented or published and are only available on clinicaltrials.gov.
  • In a 12-week, 302 patient, Phase III trial (NCT03660943), treatment with CNTX-4975 did not reduce the Weekly Pain With Walking score in the index knee compared to placebo in patients with moderate-to-severe osteoarthritis knee pain. 
  • In a 12-week, 332 patient, Phase III trial (NCT03429049), treatment with CNTX-4975 did not reduce the WOMAC score in the index knee compared to placebo in patients with moderate-to-severe osteoarthritis of the knee.
 Incyte discontinued the six-month, 157 patient, Phase II/III, GRAVITAS-309 trial, when interim data did not demonstrate efficacy for itacitinib in the treatment of chronic graft-versus-host disease in the 28-day, Part 1 of the trial. Incyte discontinued development of itacitinib after failure in the GRAVITAS-309 trial.
 
Paxalisib was being evaluated as a treatment for glioblastoma as part of the 550 patient, Phase II/III GBM AGILE trial, which is testing multiple treatments for glioblastoma. Paxalisib was dropped from the GBM AGILE trial, when it did not meet efficacy criteria in the Phase II portion of the trial.
 
Isofol announced that in a 490 patient, Phase III, AGENT trial, arfolitixorin did not improve the ORR compared to leucovorin in patients with metastatic colorectal cancer, who were being treated with 5-FU, oxaliplatin, and bevacizumab. Isofol will announce future plans for arfolitixorin in 2023, after a full analysis of the AGENT trial is completed.
 
Published Research Updates
 
In a 48-week, 40 patient, open-label trial, treatment with tofogliflozin and glimepiride each improved liver histological and metabolic parameters in patients with type 2 diabetes and nonalcoholic fatty liver disease.
 
In the 52-week, 407 patient, Phase III, ASCEND-TD trial, switching patients from epoetin to daprodustat was non-inferior to continuing epoetin (10.45 vs 10.51 g/dl) in CKD patients who were undergoing dialysis. 
 
In the 60 patient, open-label Phase II, CONCERTO trial, treatment with olaparib plus cediranib resulted in an objective response rate of 15.3% in PARP inhibitor-naive patients with non-germline-BRCA-mutated platinum-resistant recurrent ovarian cancer.
 
In the 52-week, 316 patient, Phase II, PASADENA trial, treatment with prasinezumab did not improve the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score compared to placebo in patients with early Parkinson's Disease (PD).

    Stay informed, subscribe to the 
    ​
    Prescribe Right Pharmaceutical Pipeline Tracker
    Latest Tweets from Prescribe Right

    Archives

    May 2023
    April 2023
    March 2023
    February 2023
    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.