Rheumatology

New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies

Retrieved on: 
Sunday, February 25, 2024
Teens, Women, Children, Men, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, Bangladesh Technical Education Board, AAAAI, Johns Hopkins Children's Center, Research, Food allergy, Hazelnut, NIH, FDA, Food, Immunoglobulin E, Rheumatology, NEJM, Risk, Annual general meeting, Safety, Roche, Milk, ROG, Fear, Patient, Medicine, Asthma, Face, American Academy, Pharmaceutical industry

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.

Key Points: 
  • Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.
  • The U.S. Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.
  • “While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy.
  • “The OUtMATCH study demonstrated that anti-IgE therapy increased most patients’ threshold for an allergic reaction.

PK MED Announces FDA Clearance to Initiate Its Clinical Program for PKM-01, for Local Treatment of Gout Flares, Directly by a Phase 2 Trial

Retrieved on: 
Monday, February 26, 2024
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, Managed Care, Health, Pharmaceutical, Science, Toxicity, Arthritis, Ankle, Diet, Inflammation, Obesity, Ageing, Food, Pain, News, Gout, Colchicine, Doctor of Philosophy, Prevalence, Safety, Rheumatology, Joint, Haematopoietic system, Contraindication, Patient, Knee, Ropivacaine, Pharmaceutical industry

During a Type B pre-IND meeting1, the Food and Drug Administration gave its clearance to directly initiate the clinical program for PKM-01 with a phase 2 trial for gout patients, without undertaking phase 1 studies.

Key Points: 
  • During a Type B pre-IND meeting1, the Food and Drug Administration gave its clearance to directly initiate the clinical program for PKM-01 with a phase 2 trial for gout patients, without undertaking phase 1 studies.
  • PKM-01 is a local intra-articular injection treatment for gout flares, developed by PK MED, aiming to provide a fast an effective pain relief and powerful and safe anti-inflammatory effect.
  • Thanks to its low-risk toxicity profile, PKM-01's clinical program will start directly in phase 2, which should considerably speed up time-to-market.
  • PK MED is now entering the fund-raising phase to finance PKM-01 phase 2 clinical trials.

"Double Life" of Key Immune Protein Reveals New Strategies for Treating Cancer and Autoimmune Diseases

Retrieved on: 
Friday, March 8, 2024
Bangladesh Technical Education Board, University of Oslo, Cancer, University, The central science, Immune system, Research, Doctor of Philosophy, Science Immunology, National Institutes of Health, MD, Moses Austin, Neoplasm, Inflammation, Wang, Wellcome Trust, Rheumatology, Lupus, PD-1, Bristol Myers Squibb, Howard Hughes Medical Institute, Biochemistry, NYU, Autoimmunity, Perlmutter, Rheumatoid arthritis, Pathology, Ligand, Pharmacology, NYU Langone Health, Patient, Hanmi Pharmaceutical, Internal medicine, Biomedical sciences, Funding of science, Columbia University, Mouse, Vaccine

The same findings also support experimental treatment strategies for autoimmune diseases, in which the immune system attacks the body, because stimulating the action of PD-1, as opposed to restricting it, can potentially block an overactive immune response.

Key Points: 
  • The same findings also support experimental treatment strategies for autoimmune diseases, in which the immune system attacks the body, because stimulating the action of PD-1, as opposed to restricting it, can potentially block an overactive immune response.
  • The study results revolve around the body's immune system, which is primed to attack virally infected and cancerous cells while leaving normal cells alone.
  • The immune system recognizes tumors as abnormal, but cancer cells can hijack checkpoints to turn off immune responses.
  • At the same time, PD-1 signaling is slowed in autoimmune diseases like rheumatoid arthritis, lupus, and type 1 diabetes, such that the action of unchecked immune cells creates inflammation that can damage tissues.

New England Journal of Medicine publishes Phase III data showing Xolair® (omalizumab) significantly reduced allergic reactions across multiple foods in people with food allergies

Retrieved on: 
Sunday, February 25, 2024
Bangladesh Technical Education Board, AAAAI, Johns Hopkins Children's Center, Research, Food allergy, Hazelnut, NIH, FDA, Immunoglobulin E, Rheumatology, NEJM, Life, Risk, Annual general meeting, Safety, Milk, Fear, Associate, Patient, Novartis, Asthma, Food, Face, American Academy, Pharmaceutical industry

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials4.

Key Points: 
  • Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials4.
  • The US Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.
  • "While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy.
  • The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure."

ARS Pharmaceuticals to Present Positive Clinical Efficacy Data for neffy® (epinephrine nasal spray) at 2024 AAAAI Annual Meeting

Retrieved on: 
Monday, February 5, 2024
Principal, SAN, AAAAI, ARS, Human, Allergy, Asthma, Society, Caregiver, Safety, Hospital, Temperature, American Academy, FDA, Classification, Ageing, Adrenaline, Rheumatology, Quality of life, Risk, Death, PDUFA, Treatment, NDA, Pharmaceutical industry

The meeting will be held February 23-26, 2024, in Washington, DC.

Key Points: 
  • The meeting will be held February 23-26, 2024, in Washington, DC.
  • One late-breaking presentation reports efficacy outcomes for the first time with neffy in pediatric patients who developed anaphylaxis symptoms following oral food challenge.
  • The efficacy data demonstrated that 100% of patients responded to a single dose of neffy with a 16-minute median time to complete resolution of anaphylaxis symptoms.
  • Clinical data in this neffy trial is therefore in line with historical clinical response data for injection products.

Shields Health Solutions and Sharp HealthCare Partner to Enhance Specialty Pharmacy Services

Retrieved on: 
Tuesday, January 30, 2024
Health, Pharmaceutical, Partnership, Cardiology, Prescription, Patient, Sharp HealthCare, Pharmacy, Physician, Shield, Hematology, Rheumatology, Hospital

Shields Health Solutions (Shields), the premier specialty pharmacy accelerator in the country, announced today that it has partnered with Sharp HealthCare (Sharp), a not-for-profit regional healthcare group in San Diego, to collaborate on an expansion of a specialty pharmacy program that provides patients with complex, chronic conditions access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health.

Key Points: 
  • Shields Health Solutions (Shields), the premier specialty pharmacy accelerator in the country, announced today that it has partnered with Sharp HealthCare (Sharp), a not-for-profit regional healthcare group in San Diego, to collaborate on an expansion of a specialty pharmacy program that provides patients with complex, chronic conditions access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health.
  • “Our new partnership with Sharp HealthCare reaffirms the health system’s unwavering commitment to providing superior patient care,” said Stephen West, Chief Executive Officer.
  • “Our partnership with Shields specifically supports Sharp Specialty Pharmacy’s goal to enhance and grow this vital pharmacy service for Sharp HealthCare’s patients,” said Suzanne Shea, vice president of System Pharmacy and Clinical Nutrition at Sharp HealthCare.
  • “This focused support allows our pharmacy team to expand care for Sharp patients and extend our high-quality services throughout the patients’ health care journey.”

Alkeus Pharmaceuticals Appoints Seemi Khan, M.D., Chief Medical Officer

Retrieved on: 
Tuesday, January 23, 2024
Assistant, Patient, Paratriathlon, Quark Pharmaceuticals, Biogen, Reata Pharmaceuticals, Stargardt disease, Public health, Acquisition, Disease, Brandeis University, Harvard University, AbbVie, Rheumatology, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Alkeus Pharmaceuticals, Inc. today announced that Seemi Khan, M.D., M.P.H., M.B.A., has joined the Company as Chief Medical Officer.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Alkeus Pharmaceuticals, Inc. today announced that Seemi Khan, M.D., M.P.H., M.B.A., has joined the Company as Chief Medical Officer.
  • “We are thrilled to welcome Dr. Khan to the Alkeus executive team as we pursue our mission to innovate transformative therapies for degenerative eye diseases,” said Leonide Saad, Ph.D., President and CEO at Alkeus.
  • “An accomplished executive, Dr. Khan has a track record in bringing rare disease treatments to patients in need across multiple therapeutic areas.”
    Prior to joining Alkeus, Dr. Khan served as Chief Medical Officer at Reata Pharmaceuticals through its acquisition by Biogen, where she oversaw all clinical programs from early stage to commercialization.
  • My commitment to medical innovation and patient care aligns seamlessly with Alkeus' mission, and I look forward to driving forward this life-changing treatment."

Changes Afoot for the Treatment of Psoriatic Arthritis with Marked Gains in Preference and Utilization of IL-17 Inhibitors

Retrieved on: 
Monday, January 22, 2024
Need for Speed, Psoriatic arthritis, Patient, US FDA, RealTime, TNF, Joint, Rheumatology, Mechanism of action, HCP, Skin, Secukinumab, MOA, Physician, Pharmaceutical industry

However, recent years have witnessed a transformative shift in both the US and EU markets, as rheumatologists increasingly favor alternative mechanisms, notably IL-17 inhibitors.

Key Points: 
  • However, recent years have witnessed a transformative shift in both the US and EU markets, as rheumatologists increasingly favor alternative mechanisms, notably IL-17 inhibitors.
  • In contrast, within that timeframe, rheumatologists saw a preference for IL-17s more than double, indicating a noteworthy transformation in treatment preferences.
  • Over half of rheumatologists cite efficacy as their primary motive for favoring IL-17 inhibitors in PsA treatment, regularly underscoring the class’s success in treating both skin and joint manifestations.
  • As the treatment landscape for PsA undergoes dynamic changes, staying ahead of these shifting trends becomes essential for effective patient management and optimal treatment outcomes.

Crnic Institute Awarded Anschutz Acceleration Initiative Grant for Pioneering Research Aimed at Improving the Health of Children with Down Syndrome

Retrieved on: 
Thursday, January 18, 2024
Assistant professor, Network affiliate, Anschutz Medical Campus, Research, Database, AAI, Congress, Philip Anschutz, Associate professor, Health, Rheumatology, JAK, CO, Anschütz, University, MSCS, Quality of life, Chromosome, NIH, Colorado State University, Doctor of Philosophy, T21, Crnić, Inflammation, Doctor of Psychology, Clinical trial, Anna, Immune system, Pharmaceutical industry

“Receiving this grant is deeply gratifying,” says Dr. Joaquín Espinosa, Professor in Pharmacology and Executive Director of the Crnic Institute.

Key Points: 
  • “Receiving this grant is deeply gratifying,” says Dr. Joaquín Espinosa, Professor in Pharmacology and Executive Director of the Crnic Institute.
  • “Everyone at the Crnic Institute, GLOBAL and all our Affiliates have worked so hard in the last ten years to take our remarkable findings from the Petri dish and parlay that into benefit for people with Down syndrome.
  • Key outstanding questions specific to individuals with Down syndrome will be addressed:
    What are the impacts of interferon hyperactivity during early childhood?
  • From over 165 letters of intent and ultimately 56 full proposals, 9 research projects were funded.

House Rx and Carolina Blood and Cancer Care Associates Announce New Partnership to Expand Access to Cancer Medications

Retrieved on: 
Monday, January 29, 2024
Patient, MD, Health, Partnership, Rheumatology, Pharmacist, Associate, Cancer, Quality of life, Oncology, Nursing, Pharmacy, Blood, Physician, Hospital

ROCK HILL, S.C., Jan. 29, 2024 /PRNewswire-PRWeb/ --

Key Points: 
  • Carolina Blood and Cancer Care Associates (CBCCA), a community cancer treatment center in South Carolina has partnered with House Rx, the leader in medically integrated dispensing solutions, to expand the reach of CBCCA's existing specialty medication program.
  • - Dr. Kashup Patel, MD and CEO of Carolina Blood and Cancer Care Associates
    Medically integrated dispensing centralizes the roles of physicians, nurses, pharmacists, and technicians, ensuring cohesive patient care.
  • "We are excited to join forces with Dr. Patel and the team at Carolina Blood and Cancer Care Associates.
  • Our shared commitment to patient-centered care and innovation makes this partnership a natural fit," stated Tesh Khullar, House Rx Co-Founder & President.