Immunosuppressants

Use of Takeda's Entyvio SC in Inflammatory Bowel Disease Has Slowed Considerably in the EU5 as Gastroenterologists Eye Potential New Launches Later This Year

Retrieved on: 
Tuesday, June 8, 2021
Drugs, Medical specialties, Immunosuppressants, Vedolizumab, Medroxyprogesterone acetate

While not overt, there are several data points that suggest efficacy concerns for Entyvio SC have increased among EU5 gastroenterologists in the past six months.

Key Points: 
  • While not overt, there are several data points that suggest efficacy concerns for Entyvio SC have increased among EU5 gastroenterologists in the past six months.
  • While not unusual for a newly-launched therapy, the discontinuation rate for Entyvio SC increased in both UC and CD as compared to the previous wave.
  • Similarly, "concerns about efficacy" increased as a barrier to Entyvio SC prescribing in UC and CD.
  • The percentage of severe UC patients who are considered candidates for Entyvio SC in UC decreased by eleven points since the last wave.

TFF Pharmaceuticals Hosting Key Opinion Leader Perspectives on Thin Film Freezing Applications

Retrieved on: 
Monday, June 7, 2021
Health care, Astellas Pharma, Immunosuppressants, Macrolides, Tacrolimus, Health, Pharmaceutical industry in China, Drugs

AUSTIN, Texas, June 07, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that it will host a key opinion leader (KOL) perspectives webinar on thin film freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines.

Key Points: 
  • AUSTIN, Texas, June 07, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that it will host a key opinion leader (KOL) perspectives webinar on thin film freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines.
  • TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform.
  • TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder.
  • To learn more about TFF Pharmaceuticals and its product candidates, visit the Companys website at https://tffpharma.com.

Celltrion Healthcare launches Remsima™ SC, the world's first subcutaneous formulation of infliximab in Canada, for the treatment of people with rheumatoid arthritis

Retrieved on: 
Monday, June 7, 2021
Drugs, Health care, Pharmacology, Monoclonal antibodies, Immunosuppressants, TNF inhibitors, Janssen Biotech, Infliximab, Janssen Pharmaceutica, Celltrion, Subcutaneous, Autoinjector

Remsima SC is commercially available in Canada in 120 mg fixed dose as a pre-filled pen (auto-injector) and is administered as a bi-weekly subcutaneous injection.

Key Points: 
  • Remsima SC is commercially available in Canada in 120 mg fixed dose as a pre-filled pen (auto-injector) and is administered as a bi-weekly subcutaneous injection.
  • "Having a subcutaneous formulation of infliximab means patients can have a more flexible dosing schedule and control on how they receive their treatment."
  • CELLTRION CONNECT patient support program is designed to support patients, caregivers, and healthcare providers with access to Remsima SC.
  • Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a
    randomized phase I/III trial.

DGAP-News: MorphoSys and Incyte Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory DLBCL

Retrieved on: 
Friday, June 4, 2021
Drugs, Health care, MorphoSys, Orphan drugs, Monoclonal antibodies, Tafasitamab, Incyte, Immunosuppressants, Antineoplastic drugs, Lenalidomide, Diffuse Large B-cell Lymphoma (DLBCL), Tafasitamab, MorphoSys, Incyte, DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), TAFASITAMAB, MORPHOSYS, INCYTE

A total of 80 out of 81 enrolled study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis at approximately three years follow-up (>=35 months).

Key Points: 
  • A total of 80 out of 81 enrolled study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis at approximately three years follow-up (>=35 months).
  • In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally.
  • Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.
  • Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose.

Incyte and MorphoSys Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory DLBCL

Retrieved on: 
Friday, June 4, 2021
Research, FDA, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, Drugs, Orphan drugs, Immunosuppressants, Antineoplastic drugs, Aromatic amines, Non-Hodgkin lymphoma, Tafasitamab, Lenalidomide, Diffuse large B-cell lymphoma, MorphoSys, Immunomodulatory imide drug, Diffuse Large B-cell Lymphoma (DLBCL), L-MIND, Tafasitamab, Incyte, MorphoSys, DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), L-MIND, TAFASITAMAB, INCYTE, MORPHOSYS

Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

Key Points: 
  • Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
  • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
  • Long-term analyses from L-MIND, a Phase II study of tafasitamab (MOR208) combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).

World Rheumatoid Arthritis (RA) Disease Analysis and Market Report 2020-2025: Spearheaded by Humira and Enbrel, the anti-TNF Class will Remain Dominant, Despite Pressure from Biosimilars - ResearchAndMarkets.com

Retrieved on: 
Friday, June 4, 2021
Health, General Health, Drugs, Medical specialties, Clinical medicine, Immunosuppressants, TNF inhibitors, Rheumatology, Biotechnology, Monoclonal antibodies, Adalimumab, Biosimilar, Etanercept, Rheumatoid arthritis

The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition.

Key Points: 
  • The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition.
  • The EU market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance of biosimilars compared to other countries.
  • As multi-billion-dollar products, Humira and Enbrel represent the best-selling brands in the market, and their stronghold will continue.
  • AbbVie's experience and presence in the RA market will foster success for the drug, despite its third-to-market status.

Adaptive Biotechnologies Included in More than 20 Abstracts at ASCO and EHA 2021 Highlighting Expanding Use Cases for MRD Testing with the clonoSEQ® Assay in Blood Cancer Patients

Retrieved on: 
Thursday, June 3, 2021
Drugs, Clinical medicine, Chemical compounds, Orphan drugs, Immunosuppressants, Antineoplastic drugs, Bristol-Myers Squibb, Leukemia, Minimal residual disease, Multiple myeloma, Elotuzumab, Carfilzomib

Interim analysis of a phase 2 minimal residual disease (MRD)-adaptive trial of elotuzumab, carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) for newly diagnosed multiple myeloma (MM).

Key Points: 
  • Interim analysis of a phase 2 minimal residual disease (MRD)-adaptive trial of elotuzumab, carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) for newly diagnosed multiple myeloma (MM).
  • The clonoSEQ Assay is the first and only FDA-cleared assay for MRD in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL).
  • Minimal residual disease (MRD) refers to the small number of cancer cells that can stay in the body during and after treatment.
  • We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

Dermavant Submits New Drug Application (NDA) to FDA for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis

Retrieved on: 
Thursday, June 3, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical trials, Organ systems, Psoriasis, Medical specialties, Immunology, Immunosuppressants, Monoclonal antibodies, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT

Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis.

Key Points: 
  • Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis.
  • Todays NDA submission marks a significant milestone as we work toward FDA approval of tapinarof for adults with plaque psoriasis and their dermatologists who are looking to fill current treatment gaps.
  • PSOARING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab, YuflymaTM (CT-P17) in Patients With Rheumatoid Arthritis at EULAR 2021

Retrieved on: 
Wednesday, June 2, 2021
Health, Other Science, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Monoclonal antibodies, Immunosuppressants, TNF inhibitors, Adalimumab, Celltrion, CT-P17 (biosimilar adalimumab), Remsima® CT-P13 subcutaneous (SC) formulation4,5, Celltrion Healthcare, CT-P17 (BIOSIMILAR ADALIMUMAB), REMSIMA® CT-P13 SUBCUTANEOUS (SC) FORMULATION4,5, CELLTRION HEALTHCARE

After the second randomisation, 303 patients continued with CT-P17, 153 patients continued with reference adalimumab and 151 patients were switched from reference adalimumab to CT-P17 up to week 48.

Key Points: 
  • After the second randomisation, 303 patients continued with CT-P17, 153 patients continued with reference adalimumab and 151 patients were switched from reference adalimumab to CT-P17 up to week 48.
  • Results demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients receiving maintenance therapy and in patients switched from reference adalimumab to CT-P17 up to week 52.
  • Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients access to advanced therapies.
  • Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries.

Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis

Retrieved on: 
Tuesday, June 1, 2021
Immunosuppressants, Life sciences, Secukinumab, Health care, Companies, Novartis, Food and Drug Administration

"Today's FDA approval represents an important milestone for Cosentyx demonstrating our commitment to help meet the needs of pediatric plaque psoriasis patients and their families," said Victor Bulto, President, Novartis Pharmaceuticals Corporation.

Key Points: 
  • "Today's FDA approval represents an important milestone for Cosentyx demonstrating our commitment to help meet the needs of pediatric plaque psoriasis patients and their families," said Victor Bulto, President, Novartis Pharmaceuticals Corporation.
  • This Cosentyx approval is based on two Phase III studies evaluating the use of Cosentyx in children aged 6 to
  • "Living with psoriasis is challenging, and can be highly stressful for children and adolescents," said Randy Beranek, President and CEO, National Psoriasis Foundation.
  • "Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis."