Immunosuppressants

Sorrento Reports Positive Initial Result in Dosing of First Enbrel-Non-Responding Rheumatoid Arthritis Patient With the Sofusa® Lymphatic Drug Delivery Device

Retrieved on: 
Thursday, May 20, 2021
Medical specialties, Clinical medicine, Medicine, Rheumatology, Arthritis, Immunosuppressants, TNF inhibitors, Rheumatoid arthritis, Etanercept

After a 1-hour administration with Sofusa, elevated lymph node concentrations have been measured beyond 72 hours.\nClinical study STI-SOFUSA-1003 is focused on patients with moderate to severe Rheumatoid Arthritis.

Key Points: 
  • After a 1-hour administration with Sofusa, elevated lymph node concentrations have been measured beyond 72 hours.\nClinical study STI-SOFUSA-1003 is focused on patients with moderate to severe Rheumatoid Arthritis.
  • Patients eligible for this study are those who failed to develop an adequate response to Enbrel delivered through SC injections.
  • While this is just the first patient in an open label study, this initial result is quite encouraging and in the right direction.
  • \xe2\x80\x9cIn Collagen Induced Arthritic pre-clinical models, we have seen an improvement in lymphatic pumping when delivering Enbrel with Sofusa vs subcutaneous injections.

Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the 2021 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021
Drugs, Orphan drugs, Chemical compounds, Antineoplastic drugs, Teratogens, Immunosuppressants, Pyrazines, Selinexor, Daratumumab, Immunomodulatory imide drug, Lenalidomide, XPO1

The data presented this year continue to demonstrate the broad clinical utility of XPO1 inhibition across a growing range of cancer types."\n1.

Key Points: 
  • The data presented this year continue to demonstrate the broad clinical utility of XPO1 inhibition across a growing range of cancer types."\n1.
  • These analyses support the use of the XVd combination for patients with disease refractory to lenalidomide and likely to any IMiD.
  • The data suggest that the regimen was active even in patients with daratumumab-refractory MM.
  • Compared to historical controls who did not receive selinexor, median OS was much longer among these patients.

US Supreme Court denies Sandoz petition to review biosimilar Erelzi® (etanercept-szzs) case

Retrieved on: 
Monday, May 17, 2021
Life sciences, Drugs, Health care, Immunosuppressants, TNF inhibitors, Biotechnology, Amgen, Etanercept, Biosimilar, Generic drug, XC2, Sandoz

b'Basel, Switzerland, May 17, 2021 \xe2\x80\x93 Sandoz, a global leader in biosimilar and generic medicines, today announced that the US Supreme Court has denied its petition to review the Federal Circuit\xe2\x80\x99s July 2020 decision concerning the Sandoz biosimilar Erelzi\xc2\xae (etanercept-szzs) for reference medicine Enbrel\xc2\xae* (etanercept).

Key Points: 
  • b'Basel, Switzerland, May 17, 2021 \xe2\x80\x93 Sandoz, a global leader in biosimilar and generic medicines, today announced that the US Supreme Court has denied its petition to review the Federal Circuit\xe2\x80\x99s July 2020 decision concerning the Sandoz biosimilar Erelzi\xc2\xae (etanercept-szzs) for reference medicine Enbrel\xc2\xae* (etanercept).
  • The Federal Circuit previously ruled against Sandoz in a divided decision upholding Amgen\xe2\x80\x99s patents.\n\xe2\x80\x9cWe are disappointed the Supreme Court decided not to review our case,\xe2\x80\x9d said Keren Haruvi, President of Sandoz US and Head of North America.
  • Therefore, physicians and patients can expect the same clinical outcome.\nErelzi is the Sandoz biosimilar of the reference medicine Enbrel\xc2\xae.
  • Erelzi has been studied in a global development program, which included a comprehensive comparison of Erelzi and Enbrel\xc2\xae at the analytical, preclinical, and clinical levels.

Leading Peer-Reviewed Ophthalmic Journal Publishes Study on ImprimisRx’s Proprietary Klarity-C® Drops

Retrieved on: 
Monday, May 17, 2021
Medical specialties, Drugs, Health care, Ciclosporin, Immunosuppressants, Ophthalmology, Ophthalmic, Optometry

No adverse events were observed.\nImprimisRx is one of the nation\xe2\x80\x99s leading ophthalmic-focused prescription pharmaceutical companies, serving thousands of ophthalmologists and optometrists in all 50 states, with 40 proprietary ophthalmic formulations.

Key Points: 
  • No adverse events were observed.\nImprimisRx is one of the nation\xe2\x80\x99s leading ophthalmic-focused prescription pharmaceutical companies, serving thousands of ophthalmologists and optometrists in all 50 states, with 40 proprietary ophthalmic formulations.
  • Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years.
  • Efficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial.
  • A Clinical Phase II study to assess efficacy, safety, and tolerability of waterfree cyclosporine formulation for treatment of dry eye disease.

Aurinia Pharmaceuticals to Participate in Two Upcoming Investor Conferences

Retrieved on: 
Friday, May 14, 2021
Biotechnology, Pharmaceutical, Health, Immunosuppressants, Peptides, Voclosporin

b'Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the \xe2\x80\x9cCompany\xe2\x80\x9d) today announced that members of the executive management team will participate in two upcoming investor conferences:\nRBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 10:55 a.m.

Key Points: 
  • b'Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the \xe2\x80\x9cCompany\xe2\x80\x9d) today announced that members of the executive management team will participate in two upcoming investor conferences:\nRBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 10:55 a.m.
  • ET; and\nOppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 10:45 a.m. ET.\nIn order to participate in the audio webcast, interested parties can access the live webcast under "News/Events\xe2\x80\x9d through the \xe2\x80\x9cInvestors\xe2\x80\x9d section of the Aurinia corporate website at www.auriniapharma.com .
  • The Company has introduced LUPKYNIS\xe2\x84\xa2 (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN).
  • The Company\xe2\x80\x99s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210514005073/en/\n'

Mustang Bio Announces MB-106 CD20-Targeted CAR T Data Selected for Presentation at European Hematology Association 2021 Virtual Congress

Retrieved on: 
Wednesday, May 12, 2021
Medical specialties, Clinical medicine, Branches of biology, Immune system disorders, Orphan drugs, Cancer immunotherapy, Immunosuppressants, Tocilizumab, Immunology, Cytokine release syndrome, Chimeric antigen receptor T cell, Gene therapy

Cytokine release syndrome occurred in 3 patients (25%): 2 patients with grade 1 and 1 patient with grade 2.

Key Points: 
  • Cytokine release syndrome occurred in 3 patients (25%): 2 patients with grade 1 and 1 patient with grade 2.
  • Only 1 patient required tocilizumab and dexamethasone, and no immune effector cell-associated neurotoxicity syndrome of any grade was observed.
  • Among patients who received the highest two dose levels, DL3 (3.3x106 CAR T cells/kg; n=4) and DL4 (1x107 CAR T cells/kg; n=1), CR rate was 100% (5/5).
  • Mustang has partnered with top medical institutions to advance the development of CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID.

Legend Biotech Reports New and Updated Data from BCMA CAR-T Program at 2021 ASCO and EHA Meetings

Retrieved on: 
Wednesday, May 12, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Orphan drugs, Health sciences, Health care, Janssen Pharmaceutica, Immunosuppressants, Pyrazines, Teratogens, Bortezomib, Multiple myeloma, Immunomodulatory imide drug, Janssen Biotech, CARTITUDE-1, CARTITUDE-2, Multiple Myeloma, Cilta-cel, Legend Biotech, CARTITUDE-1, CARTITUDE-2, MULTIPLE MYELOMA, CILTA-CEL, LEGEND BIOTECH

In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

Key Points: 
  • In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.
  • In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020.
  • In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Apellis to Present Long-Term Pegcetacoplan Data in PNH at the European Hematology Association Virtual Congress

Retrieved on: 
Wednesday, May 12, 2021
Orphan drugs, Eculizumab, Immunosuppressants

(Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced\xc2\xa0that seven abstracts were accepted for presentation and publication at the European Hematology Association (EHA) Virtual Congress to be held June 9-17, 2021.

Key Points: 
  • (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced\xc2\xa0that seven abstracts were accepted for presentation and publication at the European Hematology Association (EHA) Virtual Congress to be held June 9-17, 2021.
  • The primary objective of this study was to establish the efficacy and safety of pegcetacoplan compared to eculizumab.
  • During the four-week run-in, patients were dosed with 1080 mg of pegcetacoplan twice weekly (n=41) in addition to their current dose of eculizumab.
  • Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and retains worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy (GA).

Alvotech Seeks to End AbbVie’s Wrongful Monopoly on Humira and Bring Affordable Arthritis Treatment to U.S.

Retrieved on: 
Tuesday, May 11, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Drugs, Health care, Health sciences, Adalimumab, Immunosuppressants, AbbVie, LinkedIn, Monopoly, Interchangeability, Pharmaceutical industry, Interchangeable parts

b'Alvotech today filed a federal lawsuit (Case 1:21-cv-00589) seeking to end the monopoly that pharmaceutical giant AbbVie has long-maintained on the adalimumab market, sold as Humira.

Key Points: 
  • b'Alvotech today filed a federal lawsuit (Case 1:21-cv-00589) seeking to end the monopoly that pharmaceutical giant AbbVie has long-maintained on the adalimumab market, sold as Humira.
  • The company is also developing AVT02 as an interchangeable product and it expects results from its ongoing interchangeability study in Q2 of this year.
  • At stake are billions of dollars of cost to the U.S. healthcare system, which is largely driven by AbbVie\xe2\x80\x99s significant price increases that its Humira monopoly makes possible.
  • For more information, please visit our website, www.alvotech.com or follow us on LinkedIn , Twitter and Facebook.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210511005833/en/\n'

Progenity Receives Funding from Crohn’s & Colitis Foundation IBD Ventures Fund to Develop Drug Delivery System for IBD

Retrieved on: 
Tuesday, May 11, 2021
Medical specialties, Clinical medicine, Immunology, Autoimmune diseases, Immunosuppressants, Abdominal pain, Colitis, Monoclonal antibodies, Ulcerative colitis, Crohn's disease, Adalimumab, Tofacitinib

The DDS could improve efficacy of treatment through increased localized drug concentration, while potentially minimizing harmful side effects associated with systemic drug delivery.

Key Points: 
  • The DDS could improve efficacy of treatment through increased localized drug concentration, while potentially minimizing harmful side effects associated with systemic drug delivery.
  • Progenity\xe2\x80\x99s lead candidates include PGN-001, a high-concentration formulation of adalimumab, and PGN-600, a high concentration, solubilized formulation of tofacitinib.
  • During 2020, less than 5% of applicants received funding, demonstrating the selectivity of the program.\n\xe2\x80\x9cWe are proud to have been chosen by the Crohn\xe2\x80\x99s & Colitis Foundation to receive funding through their IBD Ventures program.
  • The Foundation's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life for the millions of Americans living with IBD.