Rheumatology

Scilex Holding Company Announces Results from Market Research with Rheumatologists Reveal a High Degree of Interest in Gloperba® as a Liquid Colchicine Formulation Designed for Precision Dosing

Retrieved on: 
Tuesday, December 19, 2023
Food, Risk, Migraine, Diarrhea, FDA, ACR, Gout, Chronic pain, Colchicine, PALO, American College, Pharmacy, Patient, Rheumatology, Pharmaceutical industry

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

Key Points: 
  • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
  • Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1.
  • As gout cases increase every year, treatment requirements increase.
  • The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.2
    Over 17% of gout patients had gastrointestinal side effects like diarrhea.

Santhera Appoints Executive Committee Members as it Transitions into Commercial Stage

Retrieved on: 
Thursday, December 7, 2023
Neuro-ophthalmology, European Commission, Cardiology, Rheumatology, Executive Committee, Medical director, CMC, CCO, CDMO, CGMP, Doctor of Philosophy, Actelion, Civil service commission, Vamorolone, Endocrinology, DSM-IV codes, Erasmus University Rotterdam, Patient, Head, Organization, Neurology, Technical

Both will join the six-member Executive Committee effective January 1, 2024.

Key Points: 
  • Both will join the six-member Executive Committee effective January 1, 2024.
  • “Santhera is transitioning to the commercial phase and will make AGAMREE® (vamorolone) available to patients in Europe starting in Germany in early 2024, subject to approval by the European Commission.
  • Notably, he was instrumental in establishing Santhera’s European commercial operations and successfully launching the rare disease product RAXONE® in Europe which was later divested to Chiesi Group.
  • Before joining Santhera, Geert Jan held positions as Medical Director, Business Unit Director and General Manager in start-up teams in Serono, Actelion and InterMune.

Akari Therapeutics Appoints Experienced Life Sciences Entrepreneur Samir R. Patel, M.D. to Board of Directors

Retrieved on: 
Friday, December 1, 2023
Digital therapeutics, Johnson & Johnson, Biotechnology, GE Research, Autoimmunity, Rheumatology, Internal medicine, Inflammation, Therapy, University, Medical college, Scleroderma, Publication, Patient, University of Toledo, Janssen Pharmaceuticals, Pharmaceutical industry

NEW YORK and BOSTON, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of experienced life sciences entrepreneur Samir R. Patel, M.D.

Key Points: 
  • NEW YORK and BOSTON, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of experienced life sciences entrepreneur Samir R. Patel, M.D.
  • to the Akari Board of Directors.
  • “Samir is a long-time investor in Akari and brings to us broad life sciences experience and a track record of multiple successful startup companies.
  • I am pleased to welcome him to our Board of Directors at this important time in our company’s development,” said Ray Prudo, M.D., Akari Chairman.

Sandoz launches Hyrimoz® (adalimumab) high-concentration formulation in Europe, aiming to improve patient care

Retrieved on: 
Tuesday, November 21, 2023
Rheumatoid arthritis, Crohn's disease, Novartis, Rheumatology, Patient, HCF, Adalimumab, Psoriasis, Medicine, Injection, Endocrinology, Uveitis, Ulcerative colitis, Pharmaceutical industry

The HCF formulation is administered with the familiar Hyrimoz® SensoReady® pen, aiming for an enhanced yet familiar patient experience.

Key Points: 
  • The HCF formulation is administered with the familiar Hyrimoz® SensoReady® pen, aiming for an enhanced yet familiar patient experience.
  • The launch of Hyrimoz ® HCF strengthens the Sandoz biosimilar portfolio in immunology, including Erelzi® (biosimilar etanercept), Zessly® (biosimilar infliximab) and Rixathon® (biosimilar rituximab, including rheumatoid arthritis indication).
  • Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology.
  • It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development.

Pharming announces first patient dosed in pediatric clinical trial for children aged 1 to 6 years for leniolisib

Retrieved on: 
Tuesday, November 21, 2023
Associate, APDS, Food, FDA, Hope, Ageing, Rheumatology, MPH, Diagnosis, Safety, Patient, University, Pharmaceutical industry

At sites in the U.S., Japan, and the EU, the single-arm, open-label, multinational clinical trial will evaluate the safety, tolerability, and efficacy of leniolisib in 15 children, one to six years of age, who have a confirmed APDS diagnosis.

Key Points: 
  • At sites in the U.S., Japan, and the EU, the single-arm, open-label, multinational clinical trial will evaluate the safety, tolerability, and efficacy of leniolisib in 15 children, one to six years of age, who have a confirmed APDS diagnosis.
  • These patients will receive a specific, pediatric granulated formulation of leniolisib.
  • The study’s primary efficacy endpoints and secondary endpoints mirror those used to evaluate the clinical outcomes in previous leniolisib Phase II/III APDS trials for patients aged 12 and older.
  • While standard supportive therapies can ease some of the progressive, immune-related symptoms that characterize APDS, leniolisib is designed to help prevent those symptoms from arising.

Aurinia Submits IND Application to US Food & Drug Administration for AUR 200

Retrieved on: 
Wednesday, December 20, 2023
Research, FDA, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Research and development, Food, Immunoglobulin A, Autoimmune disease, BAFF, IND, IgA nephropathy, APRIL, Lupus, Mouse, BCMA, Investigational New Drug, Membrane protein, B-cell activating factor, Rheumatology, American College, Safety, B cell, Pharmaceutical industry

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.
  • AUR200 is a highly potent and specific Fc-fusion protein containing a modified B cell maturation antigen (BCMA), for enhanced binding to both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
  • “Our IND submission for AUR200 is an important step forward for Aurinia’s pipeline and our mission to change the trajectory of autoimmune disease.
  • Aurinia acquired AUR200 as part of a strategy to diversify its development pipeline and leverage existing R&D capabilities to advance innovative therapeutic solutions to help people living with autoimmune diseases.

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma

Retrieved on: 
Wednesday, November 15, 2023
Safety, Therapy, Treatment, University, Aes, Scleroderma, Clutch (eggs), Disease, Clinical trial, Biotechnology, EMA, Patient, Royal Free Hospital, FDA, American College of Rheumatology, American College, University College London, RSS, Transcriptomics technologies, MD, Quality of life, ACR, Inflammation, Fibrosis, Pharmaceutical industry, Atlit, Rheumatology

The study safety profile demonstrated that FT011 was safe and well tolerated, with no differences in adverse event (AE) rates between the treatment arms.

Key Points: 
  • The study safety profile demonstrated that FT011 was safe and well tolerated, with no differences in adverse event (AE) rates between the treatment arms.
  • There were no serious AEs reported in the study, nor any AEs resulting in study drug interruption, withdrawal or discontinuation.
  • This suggests that FT011 may have a positive effect for scleroderma patients by reducing the inflammation and fibrosis associated with the disease.
  • It is important to advance safe and effective treatments through clinical development, given the limited therapeutic options for scleroderma patients.

Dr. Alan Kivitz to Chair XBiotech’s Natrunix Program in Rheumatoid Arthritis

Retrieved on: 
Tuesday, November 14, 2023
Regeneron Pharmaceuticals, Osteoporosis, Research, Albany Medical College, UCB, Osteoarthritis, Disease, Tissue, Clinical trial, Teaching hospital, Internal medicine, Patient, Bristol Myers Squibb, Reiko True, AbbVie, Arthritis, Joint, Rheumatology, Health, Abstract, North Shore University Hospital, Pain, Janssen, APG system, Rheumatism, Confusion, GSK plc, HIV disease progression rates, Inflammation, Amgen, Cryptocurrency, Pharmaceutical industry, Pfizer, Rheumatoid arthritis, Takeda, Genentech

is now Lead Investigator & Study Chairman for its clinical research program for Natrunix in Rheumatoid Arthritis.

Key Points: 
  • is now Lead Investigator & Study Chairman for its clinical research program for Natrunix in Rheumatoid Arthritis.
  • The company has now enrolled about 33% of the 210 patients it is recruiting for a Phase II, Double-Blind, Placebo-Controlled, Randomized study, examining Natrunix in combination with methotrexate for the treatment of Rheumatoid Arthritis.
  • I am excited to be part of a clinical trial program studying a novel approach to RA.”
    Dr. Kivitz has had a prodigious medical career treating arthritis and rheumatic diseases.
  • Dr. Kivitz has authored over 500 research articles, abstracts, and clinical studies relating to osteoarthritis, osteoporosis and rheumatoid arthritis and has lectured on his findings around the world.

Trevena Reports Third Quarter 2023 Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
CNS, Sale, Webcast, TMS, POC, Senior, University, Pain, Plasma, Rheumatology, Cleveland Clinic, Patient, Transcranial magnetic stimulation, Psychiatry, Trevena, ARTEMIS, NIH, Epilepsy, Abstract, EEG, S1P, ASA, Central nervous system, Chronic pain, Alertness, Neuropathic pain, Pharmaceutical industry, Medicine, Anesthesiology

ET

Key Points: 
  • ET
    CHESTERBROOK, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the third quarter ended September 30, 2023 and provided an overview of its recent operational highlights.
  • “There is a significant need for safe and effective non-opioid therapies in pain, and for novel mechanisms for the treatment of epilepsy.
  • The Company previously announced preliminary topline data from two Phase 1 proof-of-concept studies evaluating S1PR mechanism of action and CNS target engagement.
  • As part of the R-Bridge Financing, Trevena may receive an additional $10 million upon achievement of either a commercial or financing milestone.

STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara

Retrieved on: 
Friday, November 10, 2023
Cytokine, European Economic Area, Safety, Dermatology, Perfusion, Psoriasis, EMA, Patient, Biosimilar, CHMP, Rheumatology, Psoriatic arthritis, Gastroenterology, Partnership, Adalimumab, Generic drug, Pharmaceutical industry, Vaccine, Ustekinumab

Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.

Key Points: 
  • Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.
  • STADA holds commercial rights within Europe, where the company already markets six approved biosimilars, including in gastrointestinal, dermatology and rheumatology indications.
  • STADA’s Global Specialty Head, Bryan Kim, commented: “This positive CHMP opinion puts STADA and Alvotech in prime position to improve patient access in the ustekinumab and interleukin inhibitor markets.
  • AVT04 was designed using the Sp2/0 host cell line and is manufactured using a perfusion process, like the reference product Stelara.