Immunosuppressants

Bio-Thera Solutions Announces the First Patient Dosed in Phase III Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)

Retrieved on: 
Thursday, July 15, 2021
Oncology, Health, Clinical trials, Research, Pharmaceutical, Science, Drugs, Life sciences, Health care, Biotechnology, Biosimilar, Specialty drugs, Immunosuppressants, Monoclonal antibodies, Bevacizumab, Ustekinumab

Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that the first patient has been dosed in a Phase III clinical study for BAT2206, a proposed biosimilar of Stelara (ustekinumab).

Key Points: 
  • Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that the first patient has been dosed in a Phase III clinical study for BAT2206, a proposed biosimilar of Stelara (ustekinumab).
  • BAT2206 is Bio-Thera's fourth biosimilar to enter a global phase III clinical study, commented Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions.
  • Bio-Thera Solutions is developing several additional proposed biosimilars, including a bevacizumab biosimilar and a tocilizumab biosimilar that have both successfully completed global Phase III clinical trials.
  • 2 QLETLI is a registered trademark of Bio-Thera Solutions, Ltd.
    3 is a registered trademark of Bio-Thera Solutions, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210715005583/en/

TFF Pharmaceuticals Announces Completion of Enrollment and Preliminary Data from its Phase 1 Clinical Trial of Tacrolimus Inhalation Powder

Retrieved on: 
Tuesday, July 13, 2021
Branches of biology, Drugs, Biology, Orphan drugs, Astellas Pharma, Immunosuppressants, Macrolides, Tacrolimus, Magnesium in biology, Dose

In the Single Ascending Dose (SAD) phase of the trial, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects.

Key Points: 
  • In the Single Ascending Dose (SAD) phase of the trial, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects.
  • Peak blood levels were measured 15 min after dosing, and trough blood levels were measured 12 hours after dosing for each subject.
  • These data demonstrate that low dosing of Tacrolimus Inhalation Powder (0.5-1.0 mg) can achieve blood levels that are sufficient for efficacious immunosuppression.
  • TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder.

Global Ulcerative Colitis Clinical Landscape Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, July 12, 2021
Health, Pharmaceutical, Medical specialties, Clinical medicine, Drugs, Monoclonal antibodies, Immunosuppressants, TNF inhibitors, Diarrhea, Autoimmune diseases, Ulcerative colitis, Infliximab, Adalimumab, Colitis

The "Disease Analysis: Ulcerative Colitis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Disease Analysis: Ulcerative Colitis" report has been added to ResearchAndMarkets.com's offering.
  • As specialty products, therapies for ulcerative colitis (UC) can be expensive, and formulary positioning is paramount to product uptake.
  • Payers are settled in vital contracts that lead them to prioritize broad immunology drugs Humira and Remicade.
  • This has posed a high barrier to newer entrants to the market, which cannot compete in volume and rebates.

STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial

Retrieved on: 
Friday, July 9, 2021
Medical specialties, Clinical medicine, Medicine, Diarrhea, Autoimmune diseases, Immunosuppressants, Monoclonal antibodies, Janssen Biotech, Ustekinumab, Ulcerative colitis, Headache, Cancer

After starting STELARA, call your doctor right away if you have any symptoms of an infection (see above).

Key Points: 
  • After starting STELARA, call your doctor right away if you have any symptoms of an infection (see above).
  • Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA.
  • Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
  • A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI).

ORYZON Presents Safety and Efficacy Data of Vafidemstat From the Phase II ESCAPE Trial in Severe COVID-19 Patients at ECCMID-2021

Retrieved on: 
Friday, July 9, 2021
Medical specialties, Health, Medicine, Immunosuppressants, Orphan drugs, Tocilizumab, COVID-19, Acute respiratory distress syndrome, COVID-19 drug repurposing research, RECOVERY Trial

From May 2020 to March 2021, 60 patients were randomized in this Phase II study aiming to determine the safety and efficacy of vafidemstat in COVID-19 severe patients on top of Standard of Care (SoC) treatment.

Key Points: 
  • From May 2020 to March 2021, 60 patients were randomized in this Phase II study aiming to determine the safety and efficacy of vafidemstat in COVID-19 severe patients on top of Standard of Care (SoC) treatment.
  • Of those, 9 AEs were recorded in the vafidemstat plus SoC arm, all mild and considered not treatment-related.
  • A total of 6 patients required rescue medication (Tocilizumab): 4 patients (67%) in the SoC arm and 2 (33%) treated with vafidemstat plus SoC.
  • Vafidemstat is also being explored in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection.

Alvotech Initiates Clinical Studies for AVT04, a Proposed Biosimilar to Stelara® (Ustekinumab)

Retrieved on: 
Tuesday, July 6, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Drugs, Life sciences, Biotechnology, Articles, Biosimilar, Immunosuppressants, Monoclonal antibodies, TNF inhibitors, Adalimumab, Alvotech, AVT04 and AVT02, ALVOTECH, AVT04 AND AVT02

Alvotech, the Iceland-based biosimilar company, today announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotechs proposed biosimilar to the reference product Stelara.

Key Points: 
  • Alvotech, the Iceland-based biosimilar company, today announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotechs proposed biosimilar to the reference product Stelara.
  • In parallel, Alvotech is also conducting a PK similarity study (AVT04-GL-101) to demonstrate equivalent PK endpoints between the proposed biosimilar and the reference product Stelara.
  • AVT04 is the second proposed biosimilar product from Alvotech entering clinical studies, the first being AVT02, a proposed biosimilar to Humira.
  • Rbert Wessman, founder and Chairman of Alvotech, commented:
    As a founder, I am extremely proud to see us enter the second proposed biosimilar product into clinical trials.

Eledon Pharmaceuticals to Present at the Virtual Ladenburg Thalmann Healthcare Conference

Retrieved on: 
Tuesday, June 29, 2021
Life sciences, Biotechnology, Articles, Biopharmaceutical, Pharmaceutical industry, Pharmacy, Immunosuppressants

IRVINE, Calif., June 29, 2021 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (Eledon) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), today announced that management will present a corporate overview at the virtual Ladenburg Thalmann Healthcare Conference on Tuesday, July 13th at 2:00 pm EST.

Key Points: 
  • IRVINE, Calif., June 29, 2021 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (Eledon) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), today announced that management will present a corporate overview at the virtual Ladenburg Thalmann Healthcare Conference on Tuesday, July 13th at 2:00 pm EST.
  • Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for patients living with an autoimmune disease, patients requiring an organ or cell-based transplant, and for patients living with ALS.
  • Eledon is headquartered in Irvine, Calif. For more information, please visit the companys website at www.eledon.com .
  • Follow Eledon Pharmaceuticals on social media: @Eledon_Pharma and LinkedIn.

BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close

Retrieved on: 
Friday, June 25, 2021
Drugs, Rare diseases, Clinical medicine, Achondroplasia, Medical specialties, Immunosuppressants, Monoclonal antibodies

Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO (vosoritide).

Key Points: 
  • Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO (vosoritide).
  • "The positive opinion from the CHMP represents a significant step towards making vosoritide available as a treatment choice for families.
  • The CHMP opinion reinforces the strength of the data and the clinical benefit to children as young as two years old.
  • "This positive CHMP opinion represents a significant step toward delivering on the promise of the first pharmacological treatment option for children and families affected by achondroplasia.

Alvotech Bondholders Convert More Than $100m at Pre-Money Valuation of $2.7bn

Retrieved on: 
Friday, June 25, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Life sciences, Drugs, Health care, Biotechnology, Immunosuppressants, TNF inhibitors, Pharmaceutical industry, Adalimumab, Biosimilar, Biopharmaceutical, AbbVie, Patent

In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVies key patents.

Key Points: 
  • In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVies key patents.
  • The lawsuit also argues that AbbVies patent strategy, which has been under recent Congressional scrutiny , renders its Humira patents unenforceable.
  • Further, the lawsuit points out that AbbVie has failed to sue Alvotechs US affiliate (the actual BLA applicant) at all.
  • Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets.

Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application (MAA) for Voclosporin with the European Medicines Agency (EMA)

Retrieved on: 
Friday, June 25, 2021
Biotechnology, Pharmaceutical, Health, Medical specialties, Medicine, Clinical medicine, Kidney diseases, Immunosuppressants, Peptides, Voclosporin, Nephritis, Lupus nephritis, Lupus, European Medicines Agency, Pharmaceutical industry in China, Lupus Nephritis, Aurinia, LUPUS NEPHRITIS, AURINIA

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) announced today that the Companys licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) announced today that the Companys licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA).
  • Once the MAA is approved, OPEL would be authorized to market voclosporin in the European Union, Norway, Iceland, and Liechtenstein.
  • Lupus nephritis is a serious, complex condition that historically has lacked dedicated, approved treatment options, said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals.
  • If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.