European Pharmaceutical Review

JANUARY 11, 2024

billion, so biosimilar competition could significantly expand patient access to this biologic therapy within the fields of gastroenterology, dermatology, and rheumatology, according to STADA and Alvotech. The EU ustekinumab market is worth €2.5 In this region, STADA already has six biosimilars approved in this market.

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Immunization 105

Pharmaceutical Technology

MAY 19, 2023

Clinical response was observed after just two weeks in some cases. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology. Patients showed a visible reduction of damage to the intestinal lining after 12 weeks of 45mg Rinvoq treatment.

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Mayo Clinic Dosage FDA Immunization 105

PharmaShots

JUNE 27, 2023

The results up to Week 24 (Treatment Period 1) were previously reported at the EULAR European Congress of Rheumatology in 2022. The results from Week 24 to Week 48 (Treatment Period 2) were reported at this year’s American College of Rheumatology (ACR) Convergence. So how was your overall response? to 7.92; 95% CI -5.18

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Immunization FDA 40

Pharmaceutical Technology

MAY 12, 2023

Absci has collaborated with the University of Oxford’s Kennedy Institute of Rheumatology to expedite the development of AI-driven immunotherapies. The Kennedy Institute clinical research director Christopher Buckley stated: “Absci’s reverse immunology approach promises to turn clinical data into pharmaceutical drugs. “We

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Immunization 52

Hospital Pharmacy Europe

JUNE 15, 2023

The impact of apremilast on inflammatory and structural changes in psoriatic arthritis (PsA) can be better understood through magnetic resonance imaging (MRI), according to a recent study presented at the European Congress of Rheumatology (EULAR) 2023.

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Labelling Hospitals 52

European Pharmaceutical Review

FEBRUARY 24, 2023

“Autoimmune inflammatory muscle diseases… can end fatally if they are diagnosed at too late a stage or patients fail to react sufficiently to medicines aimed at suppressing the immune system,” explained Professor Dr Georg Schett, Director of the Department of Medicine 3 – Rheumatology and Immunology at Universitätsklinikum Erlangen.

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Immunization Hospitals 128

pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc.,

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Immunization FDA 110

pharmaphorum

NOVEMBER 11, 2022

Leading with practical insights from the best in the industry, the 4th Annual Inflammasome Therapeutics Summit is returning in person on November 29 – December 1 to Boston to equip you with the knowledge and connections to propel the next frontier of inflammasome therapeutics from pipeline to clinical and commercial reality.

Medical Schools 52

Medical Schools Immunization Hospitals 52

IDStewardship

AUGUST 1, 2023

I had the good fortune of connecting with Dr. Emre Kara at the European Congress on Clinical Microbiology and Infectious Diseases in 2022, who lives and works in Turkey as a pharmacist practicing in the area of antimicrobial stewardship. Clinical pharmacy in Turkey is still developing. I graduated from Pharmacy in June 2014.

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Hospitals Community Pharmacies Dosage Communication 212

Pharmaceutical Technology

MARCH 30, 2023

It is expected that medical societies, clinical researchers, government organisations, and particularly people living with lupus, the FDA stresses, will all contribute to address hurdles hampering the treatment landscape. The treatment landscape is therefore one that is relatively bare.

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FDA 64

pharmaphorum

NOVEMBER 11, 2022

The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. The post IQVIA’s report card for clinical trial diversity: must do better appeared first on.

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FDA 97

European Pharmaceutical Review

FEBRUARY 6, 2023

Compared to placebo, both FT011 treatment groups showed clinically meaningful improvements in the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, as early as week eight and reaching a maximum at week 12. representing the greatest probability of clinical improvement.

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Labelling 89

pharmaphorum

OCTOBER 5, 2022

.” The partners are still in the discovery stage of the collaboration, and Sanofi will take full responsibility for the programme once a drug candidate to take forward into preclinical and clinical testing has been selected. TrialSpark alliance targets six candidates.

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Med Ed 101

JUNE 17, 2020

Recently, the American College of Rheumatology released new 2020 gout guidelines. In these guidelines, there are 42 recommendations that reflect new clinical evidence since the release of the 2012 guidelines. Full text 2020 gout guidelines can be found here.

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European Pharmaceutical Review

JUNE 27, 2023

This includes maternal-foetal diseases, rare autoantibody diseases and prevalent rheumatological diseases.” Nipocalimab has been adapted through genetic approaches to optimise its clinical effect and minimise eventual side-effects.” There were no maternal or infant deaths and there were no reports of foetal hydrops.”

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Immunization 89

Hospital Pharmacy Europe

OCTOBER 30, 2023

Commenting on the development, Dr John Ingram, clinical reader and consultant dermatologist at Cardiff University, said: ‘HS is an undertreated disease that causes substantial physical and emotional distress to those who live with it. Approximately 50% of patients randomised to secukinumab had a reduction in HS-related pain at Week 52.

Hospitals 52

Hospitals 52

The Checkup by Singlecare

JANUARY 23, 2024

Lower doses of methotrexate , such as those generally implemented for rheumatologic conditions, carry less of a risk than higher doses of methotrexate employed for its antineoplastic effects. Antibiotics High doses of methotrexate administered with certain antibiotics may increase the serum concentrations of methotrexate.

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Adverse Reactions Chemotherapy Communication Immunization 52

Pharmaceutical Technology

DECEMBER 5, 2022

The data from an open-label extension of the BLISS-LN trial, recently published in the Clinical Journal of the American Society of Nephrology (CJASN), suggests that continuation or initiation of Benlysta in addition to standard therapy at 104 weeks can be beneficial in patients with LN with no new safety signals.

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Labelling FDA 59

Pharmaceutical Technology

AUGUST 2, 2022

The latest approval was based on pharmacokinetic (PK) findings and extrapolation of the validated efficacy and current safety profile of Stelara in various Phase III clinical trials carried out in adult and paediatric moderate-to-severe plaque psoriasis (PsO) patients and adult active PsA patients.

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FDA Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

OCTOBER 10, 2023

Dr. Beitz earned a Bachelor of Arts (summa cum laude and honors in chemistry) from Barnard College, Columbia University, and a Doctor of Medicine from the College of Physicians and Surgeons, Columbia University.

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FDA Hospitals 49

Board Vitals - Pharmacist

JANUARY 4, 2024

Allergic, immunologic, dermatologic, and rheumatologic disorders 4% Palliative care, medical ethics, and decision‐making 6.5% As outlined in the ABIM Focused Practice in Hospital Medicine MOC Exam Blueprint , the following topics will be tested in the exam: Inpatient and transitional care: 63.5% Gastroenterologic and hepatic disorders 10.5%

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Hospitals 52

pharmaphorum

MARCH 23, 2021

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Regeneron and Teva’s fasinumab is the only other serious contender from the class, which is in late stage clinical development.

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FDA Documentation 58

pharmaphorum

MARCH 26, 2021

After more than a decade of fraught clinical development it looks like the end of the line for Pfizer/Lilly painkiller tanezumab, which promised to be an alternative to addictive opioid painkillers. Regeneron and Teva’s fasinumab is the only other serious contender from the class, which is in late stage clinical development.

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FDA Documentation 58

The Checkup by Singlecare

FEBRUARY 10, 2023

The Symptom Severity Score used as part of the American College of Rheumatology (ACR) fibromyalgia diagnostic criteria lists 41 symptoms, including gastroesophageal syndrome ( GERD ), Raynaud’s , and hearing difficulties.

Hospitals 52

Hospitals 52

The Checkup by Singlecare

NOVEMBER 13, 2023

Sources Ibuprofen suspension , Daily Med Influence of age on the enantiomeric disposition of ibuprofen in healthy volunteers , British Journal of Clinical Pharmacology (2003) PharmGKB summary: ibuprofen pathways , Pharmacogenetics and Genomics (2015) Ibuprofen disposition in obese individuals , Arthritis & Rheumatology (1985) Ibuprofen , Medscape (..)

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Dosage Labelling 105

Pharmaceutical Technology

NOVEMBER 14, 2022

Such developments, including a 2021 approval of AstraZeneca’s Saphnelo (anifrolumab) , prompted The Lancet Rheumatology to posit that 2022 could be a “banner year” for the condition. Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva. MSCs and CAR-Ts for lupus.

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Immunization FDA 144

pharmaphorum

SEPTEMBER 30, 2022

Ventus’ pipeline also includes a centrally-acting NLRP3 drug (VENT-02) for diseases characterised by neuroinflammation and neurodegeneration, and another peripherally-acting drug (VENT-05) for respiratory and rheumatological diseases, both in preclinical development.

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pharmaphorum

SEPTEMBER 22, 2022

M3’s Maxim Polyakov and director of the Rheumatology Research Unit at Cambridge University, Dr Deepak Jadon examine how HCP engagement is evolving. As person generated health data becomes more widely recognised, a new whitepaper from Evidation explores how patient insights impact clinical decision making.

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Communication Pharmaceutical Companies Pharmaceutical Companies 52

Impact Pharmaceutical Services

AUGUST 21, 2022

In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. and 2.7.4) and 120-day Safety Updates.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Blog: Ask a Student Pharmacist

JULY 13, 2023

He completed pediatric residency at SUNY Downstate Medical Center, and a pediatric hematology/oncology fellowship at the University of Minnesota, where he also completed PhD in Experimental and Clinical Pharmacology with a focus on PKPD modeling and pharmacogenetics. 2023 Jun 15:blood.2023020035. 2023020035. doi: 10.1182/blood.2023020035

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Chemotherapy Hospitals 52

pharmaphorum

APRIL 1, 2021

NICE said that Actemra and Kineret appear to be clinically equivalent and are roughly similar in weekly cost, with the latest guidance showing Kineret’s annual cost at £9,580. Both products are available as subcutaneous injections although Actemra can also be given by infusion.

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Hospitals 63

ISPE

OCTOBER 24, 2022

Global demand for plasma-derived therapies (PDTs) continues to swell—the compacting result of an aging population, clinical successes, and recent applications for both widespread diseases and multiple rare conditions. A Resurgence in Plasma: Trends in The Industry. Eduardo Munoz, PE. 24 October 2022.

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Immunization 95

European Pharmaceutical Review

SEPTEMBER 15, 2022

Long-term data from the KEEPsAKE trials shows more than half of adult psoriatic arthritis patients receiving Skyrizi ® (risankizumab, 150mg) achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response at 100 weeks.

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Labelling Immunization Hospitals 75

The People's Pharmacy

MAY 8, 2023

By the early 1950s, patients were taking cortisone orally and receiving cortisone shots in their joints ( Clinical and Experimental Rheumatology , Sept-Oct. Prolonged corticosteroid treatment is also linked to weight gain ( Allergy, Asthma & Clinical Immunology , Aug. Others have trouble controlling their blood sugar.

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Hospitals FDA 102

The Thyroid Pharmacist

JUNE 30, 2023

6] There haven’t been any research studies or clinical trials looking specifically at LDN and Hashimoto’s. Even with the lack of scientific data, there is a lot of clinical data from my friends and colleagues who use low dose naltrexone in their practices. Low-Dose Naltrexone in Rheumatological Diseases. Clinical Rheumatology.

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Compounding Immunization Compounding Pharmacies Insurance Coverage 98

The Checkup by Singlecare

JANUARY 26, 2024

Diverticulitis is the most common cause of pain specific to the lower left abdomen, says Amy Lee , MD, RDN, chief medical officer at Lindora Clinic. Celiac Disease Foundation Intestinal obstruction , Mayo Clinic (2021) The post Why does my lower left abdomen hurt? What causes lower abdominal pain on the left side?

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Mayo Clinic Immunization Hospitals 52

pharmaphorum

DECEMBER 21, 2021

Specialty sites are able to provide specific information on one Rare Disease or a particular group of Rare Diseases, as well as general information, such as details on treatments, as well as access to expert doctors and clinical research studies. The potential to leverage genomic data.

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Pharmaceutical Companies Pharmaceutical Companies Hospitals FDA 98