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Pipeline News and Updates
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Update for January 25, 2022

1/25/2022

 
New Drugs Added to Knowledgebase
 
Last week we added 10 new drugs to the knowledgebase:
  • Aficamten, a cardiac myosin inhibitor for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
  • Arazasetron, a 5-HT3 receptor antagonist for the treatment of Sudden sensorineural hearing loss, platinum-induced ototoxicity
  • Elacestrant, a selective estrogen receptor degrader (SERD) for the treatment of Breast cancer
  • Datopotamab deruxtecan, an antibody drug conjugate (ADC) for the treatment of non-small cell lung cancer, Triple negative breast cancer, HR positive/HER2 negative breast cancer, small cell lung cancer, urothelial and gastrointestinal cancers
  • Eplontersen, an antisense drug for the treatment of ATTR amyloidosis 
  • BLU-5937, a P2X3 antagonist for the treatment of chronic cough, chronic pruritus
  • IMGN632, an antibody drug conjugate (ADC) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML)
  • YTB323, a CAR-T cell Therapy for the treatment of B-cell lymphoma
  • PHE885, a CAR-T cell Therapy for the treatment of multiple myeloma
  • Tabelecleucel, an allogeneic T-cell immunotherapy for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease
The Prescribe Right Pharmaceutical Pipeline Tracker now allows you to track 980 pipeline and recently approved drugs supported by 2.364 published and announced research results.
 
Regulatory Update
 
The FDA rejected Levo Therapeutics’ intranasal carbetocin for the treatment of Prader-Willi syndrome and requested an additional Phase III trial.
 
Pfizer announced the FDA rejected somatrogon, but did not provide a reason for the rejection.
 
The FDA rejected Merck’s gefapixant for the treatment of chronic cough and requested additional information related to measurement of efficacy. 
 
The FDA delayed the PDUFA date by three months for Bluebird Bio’s betibeglogene autotemcel, to treat transfusion-dependent beta-thalassemia, to allow more time to review additional clinical information
 
The FDA delayed the PDUFA date by three months for Bluebird Bio’s elivaldogene tavalentivec, to treat cerebral adrenoleukodystrophy, to allow more time to review additional clinical information
 
The FDA recommended that GenSight conduct an additional trial for lenadogene nolparvovec due to the unexpected bilateral vision improvement seen in unilaterally treated Leber Hereditary Optic Neuropathy patients in the RESCUE, REVERSE and REFLECT trials.
 
Announced Research Updates
 
Results from two Phase III bimekizumab trials; the axial spondyloarthritis BE MOBILE 1 trial and the psoriatic arthritis BE COMPLETE trial 
 
Results from the HIMALAYA trial evaluating the addition of tremelimumab to a regimen to treat advanced hepatocellular carcinoma.
 
18-month data from the HELIOS-A trial evaluating vutrisiran to treat hATTR amyloidosis 
 
Published Research Updates
 
Results from the Phase III, ECOSPOR III trial, evaluating SER-109 to prevent recurrent C. difficile infection.
 
Results from the Phase III, GEMSTONE-302 trial, evaluating sugemalimab in the treatment of metastatic squamous and non-squamous non-small cell lung cancer. 
 
Results from a triple-negative breast cancer adavosertib trial.
 
Results from an ovarian cancer evaluating cediranib
 
Two Phase III daridorexant insomnia trials
 
Four Phase III faricimab trials. Two evaluating faricimab as a treatment for neovascular age-related macular degeneration and two for diabetic macular edema.

​Check out our new lower subscription rates and don't miss out on these clinical updates.

Update for January 18, 2022

1/18/2022

 
Access 53 recently approved and available drugs and 22 investigational drugs on the short list for approval.

Last week we added 12 new drugs to the knowledgebase:
  1. Spesolimab to treat generalized pustular psoriasis flares
  2. Nemvaleukin to treat platinum-resistant ovarian cancer
  3. Parsaclisib to treat relapsed or refractory non-hodgkin lymphomas
  4. Isaralgagene civaparvovec to treat Fabry disease
  5. Izokibep to treat ankylosing spondylitis
  6. Icosabutate to treat nonalcoholic steatohepatitis (NASH)
  7. Ensartinib to treat ALK-positive non-small cell lung cancer (NSCLC)
  8. Simufilam to treat Mild to moderate Alzheimer's Disease
  9. Ensovibep to treat COVID-19
  10. Rencofilstat to treat nonalcoholic steatohepatitis (NASH)
  11. C-CAR039 to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
  12. BDC-1001 to treat HER2-expressing solid tumors
The Prescribe Right Pharmaceutical Pipeline Tracker now allows you to track 970 pipeline and recently approved drugs by the following search parameters:
  • 800 Indications
  • 249 Approvals
  • 663 manufacturers
  • 26 Therapeutic classes
  • Drugs with PDUFA Dates
  • Recently approved drugs
Regulatory Update 

The FDA approved abrocitinib (Cibinqo, Pfizer), on 1/14/2022, for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic therapies. Like other JAK inhibitors, abrocitinib was approved with a boxed warning regarding the increased risk for serious infections, mortality, malignancy, major cardiovascular events and thrombosis.
 
Announced Research Updates 

Sarepta announced data from 20 patients enrolled in Part 2 of a 48-week, 41 patient, Phase II trial, where treatment with delandistrogene moxeparvovec improved the NSAA score by two points compared to a 103 patient, weighted external control group (1.3 point increase vs 0.7 point decrease).

We also added six new published research updates that subscribers can review
  • Adding camrelizumab to carboplatin plus paclitaxel to treat advanced squamous non-small cell lung cancer.
  • The combination of camrelizumab and apatinib in the treatment of advanced esophageal squamous cell carcinoma.
  • Phase II results for the J&J ebola vaccine.
  • Adding spartalizumab to dabrafenib and trametinib to treat BRAF V600-mutant unresectable or metastatic melanoma.
  • Melflufen compared to pomalidomide to treat relapsed or refractory multiple myeloma patients who are receiving dexamethasone.
  • Does adding radiotherapy to tremelimumab plus durvalumab improve the overall response rate in the treatment of metastatic non-small cell lung cancer resistant to PD-1 and PD-L1 targeted therapy?
Check out our new lower subscription rates and don't miss out on these clinical updates.

Update for January 11, 2022

1/10/2022

 
Regulatory Update
 
The FDA approved daridorexant (Quviviq, Idorsia), on 1/10/2022, for the treatment of insomnia in adults.
 
The FDA accepted the NDA for tebipenem for the treatment of complicated urinary tract infections and set a PDUFA date for 6/27/2022.
 
Announced Research Updates
 
Biosight announced that in a 66 patients Phase IIb trial, treatment with aspacytarabine resulted in a 37% complete response rate in patients with acute myeloid leukemia who are not eligible for standard induction chemotherapy due to advanced age or comorbidities.
 
BioMarin announced the annualized bleeding rate was maintained at 0.8 per year (0.9 during year one and 0.7 during year two) and Factor VIII infusions at 2.6 per year (1.5 during year one and 3.4 during year two) in 112 patients enrolled in the valoctocogene roxaparvovec 
GENEr8-1 trial that had been followed for 110 weeks. 
 
Published Research Updates
 
In the 16-week, 215 patient, Phase III, TIMES 3 trial, adding imeglimin to insulin decreased HbA1c 0.6% at 16 weeks and 0.64% at 52 weeks compared to insulin alone in Japanese patients with type 2 diabetes.
 
In the 714 patient, Phase II/III, RELATIVITY-047 trial, patients treated with relatimab plus nivolumab achieved progression-free survival of 10.1 months compared to 4.6 months with nivolumab alone in patients with previously untreated metastatic or unresectable melanoma.
 
In an updated analysis of tirzepatide for the treatment of type 2 diabetes, ICER found that treatment with tirzepatide reduced HbA1c 2.5% and weight by 10.9 Kg when added to background therapy. Analyzing data from a direct comparison with semaglutide and a network meta-analysis with empagliflozin, tirzepatide has a greater decrease in HbA1c, weight loss, lipids, and blood pressure. Treatment with tirzepatide was associated with an increase in gastrointestinal adverse effects, severe adverse events, and discontinuation compared with semaglutide. Because only indirect data was available, a comparison of adverse events with tirzepatide was not possible. While semaglutide and empagliflozin have shown improvement in cardiovascular (CV) outcomes, the tirzepatide CV outcomes trial has not been completed. Due to the lack of the CV outcomes data, ICER found tirzepatide to provide comparable or better net health benefits to semaglutide and empagliflozin. ICER estimated an annual health-benefit price benchmark range of $5,500 to $5,700 for tirzepatide.

Update for January 5, 2022

1/5/2022

 
Regulatory Update
 
The FDA approved inclisiran (Leqvio, Novartis), on 12/22/2021, as an adjunct to diet and maximally tolerated statin therapy for the treatment of atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) in patients who require additional lowering of LDL-C. 
  • Inclusiran is administered as a subcutaneous injection. A second dose of inclusiran is administered 3 months after the first dose, then the drug is given every six months. 
  • Inclusiran lowers LDL by interfering with the RNA that leads to production of proprotein convertase subtilisin–kexin type 9 (PCSK9). 
  • Alirocumab (Praluent) and evolocumab (Repatha) are monoclonal antibodies that bind to PCSK9 inhibiting it action and lowering LDL. The PCSK9 antibodies are given every 2-4 weeks depending on dosing. 
  • The 54% reduction with inclisiran is similar to the 58% reduction alirocumab in the ODYSSEY trial and the 63% reduction with evolocumab in the FOURIER trial. 
  • ICER estimated the annual cost for inclisiran to be $3,600 to $6,000 a year to be cost-effective. The range is similar to the price for the two PCSK9 monoclonal antibodies, evolocumab at $5,400 and alirocumab at $5,850.
  • Novartis set WAC for inclusiran at $3,250 per dose so the initial year will cost $9,750 and subsequent years $6,500, which is high than ICER’s estimates and the annual cost for the two PCSK9 monoclonal antibodies.​
The FDA approved tralokinumab (Adbry, Leo Pharma ), on 12/28/2021, for the treatment of moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Tralokinumab can be used with or without topical corticosteroids.
 
The FDA approved levoketoconazole (Recorlev, Xeris Biopharma), on 12/30/2021, for the treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Levoketoconazole was approved with a Black Box Warning regarding hepatotoxicity and QT prolongation.
 
The FDA placed a hold on HIV trials using Gilead’s injectable lenacapavir due to concerns regarding the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles. The hold does not affect trials using the oral formulations of lenacapavir. 
 
The FDA accepted the NDA for Amylyx Pharmaceuticals’ AMX0035 for the treatment of amyotrophic lateral sclerosis(ALS) and set a PDUFA date for 6/29/2022.
 
Lexicon submitted an NDA for sotagliflozin to reduce the risk of cardiovascular complications in heart failure patients with type 2 diabetes. 
 
The FDA granted Biogen and Eisai’s lecanemab a fast-track designation as a treatment of early Alzheimer's disease.
 
Published Research Updates
 
In a 155 patient, Phase II trial, treatment with balstilimab and zalifrelimab resulted in a 25.6% objective response rate (ORR) in patients with recurrent and/or metastatic cervical cancer, who had relapsed after prior platinum-based chemotherapy. 
 
In the 28-day, 439 patient, Phase III, GRAVITAS-301 trial, adding itacitinib to corticosteroids did not improve the overall response rate compared to corticosteroids alone in patients with treatment-naive acute graft-versus-host disease.
​
In a 28-week, 189 patient, Phase III trial, treatment with MSC-NTF did not improve the number of patients that achieved a 1.25 point improvement or > per month in their Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score compared to placebo (33% vs 28%) in patients with amyotrophic lateral sclerosis (ALS). 
 
In the 16-week, 332 patient, Phase III, BE MOBILE 2 trial, more patients treated with bimekizumab achieved ASA40 compared to placebo in patients with Ankylosing Spondylitis who had an inadequate response to an NSAID or TNF-inhibitor.
 
In the 92 patient, Phase III, REALITY trial, treatment with apatinib resulted in a PFS of 22.2 months compared to 4.5 months with placebo in patients with radioactive iodine-refractory differentiated thyroid cancer.
 
In the 127 patient, Phase III TreeTopp trial, adding varlitinib to capecitabine did not improve progression-free survival or overall response rate compared to capecitabine alone in patients with biliary tract cancer.
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