European Pharmaceutical Review

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” Like Stelara, the most serious known side effect of Wezlana is infection.

Food and Drug Administration 90

Food and Drug Administration FDA Side effects Safety 90

Clarivate

APRIL 4, 2024

The prevalence and co-occurrence of immune-mediated inflammatory diseases (IMIDs) like inflammatory bowel disease and rheumatoid arthritis varies by race and ethnicity among U.S. Fortunately, RWD is beginning to offer a means of augmenting clinical trials, which can’t always furnish robust sample sizes for subpopulations. million U.S.

Electronics 52

Electronics Patients Medical FDA 52

Pharmaceutical Technology

MAY 25, 2023

Yuflyma is indicated to treat juvenile idiopathic arthritis, hidradenitis suppurativa, Crohn’s disease, plaque psoriasis, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

MAY 18, 2023

The NICE recommendation is based on data from three Phase III clinical trials, which demonstrated significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response.

Consulting 83

Consulting Marketing Safety Patients 83

European Pharmaceutical Review

SEPTEMBER 11, 2023

The reference medicine Stelara (ustekinumab) is a monoclonal antibody (mAb) treatment to interleukin (IL)-12/23 indicated for autoimmune disorders including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Biopharma 76

Biopharma Manufacturing Medicine Safety 76

European Pharmaceutical Review

JANUARY 24, 2024

It is the first prospective, large-scale, randomised-controlled clinical trial evaluating people of colour across all skin tones with moderate to severe plaque PsO and scalp PsO to objectively measure clearance and other treatment outcomes with Tremfya. percent compared to 37.8 percent versus 33.4

Medicine 79

Medicine Prospecting Patients Leads 79

European Pharmaceutical Review

DECEMBER 14, 2022

Clinical studies of Nimbus Therapeutics’ allosteric TYK2 inhibitor. In Phase I studies, NDI-034858 showed a good tolerability profile, a dose-dependent trend in exploratory clinical activity and a pharmacokinetic profile allowing for once-daily solid oral dosing. For $4 billion , Takeda will acquire Nimbus Lakshmi, Inc.,

Medicine 84

Medicine Patients Sales Medical 84

Medgadget

FEBRUARY 28, 2023

SetPoint Medical , a medtech company based in California, is developing a neuromodulatory device that is intended to treat rheumatoid arthritis. Our early preclinical and clinical research led to the development of SetPoint’s treatment platform, which is currently being evaluated in clinical trials for the treatment of RA.

Medical 95

Medical Patients FDA Recruitment 95

Pharmaceutical Technology

JUNE 19, 2023

BAT2206 is approved in the country to treat active psoriatic arthritis (PsA) in adults, either as a monotherapy or along with methotrexate. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

Food and Drug Administration 52

Food and Drug Administration Distribution Food Marketing 52

Pharmaceutical Technology

JULY 27, 2022

Clinical remission according to Adapted Mayo Score was the primary endpoint of the studies while secondary endpoints comprised clinical response and mucosal healing among others. According to the findings, the trials met the primary endpoint and all secondary endpoints with statistical significance.

Safety 52

Safety Patients Pharmaceutical 52

Pharmaceutical Technology

FEBRUARY 10, 2023

Phase III clinical trial of TAK-279 in psoriasis is expected to commence this year. These diseases include psoriatic arthritis, inflammatory bowel disease and systemic lupus erythematosus. With this transaction, Takeda has now acquired TAK-279, formerly known as NDI-034858 at Nimbus.

Safety 52

Safety Sales Pharmaceutical Patients 52

European Pharmaceutical Review

FEBRUARY 26, 2024

Clinical data showed approximately 60 percent reductions in plasma NfL concentrations in patients given Qalsody compared to placebo. After 12 weeks, patients treated with danicopan had a clinically-relevant increase in haemoglobin (an average of 2.35 This indicated reduced neuronal injury, EMA noted.

Medicine 91

Medicine Patients Marketing Pharmaceutical 91

Pharmaceutical Technology

NOVEMBER 23, 2022

A substantially higher proportion of subjects who received Skyrizi attained the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response in all the trials. In the European Union, Skyrizi also received approval to treat adults with psoriasis and psoriatic arthritis.

Food and Drug Administration 52

Food and Drug Administration Safety Food Patients 52

Pharmaceutical Technology

JUNE 5, 2023

Izokibep is under clinical development by Acelyrin and currently in Phase II for Panuveitis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Izokibep LoA Report.

Biopharma 40

Biopharma Networking Patients Pharma 40

Pharmaceutical Technology

OCTOBER 26, 2022

The Phase II MajesTEC-1 clinical trial comprised multiple myeloma patients who had received a median of five lines of therapy previously. In August, Janssen received FDA approval for Stelara (ustekinumab) for the treatment of paediatric patients aged six years and above with active psoriatic arthritis.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

pharmaphorum

JANUARY 6, 2023

a Los Angeles area-based, late-stage clinical biopharma, with additional operations in the San Francisco Bay area, has announced it is acquiring privately held ValenzaBio – which develops therapies for autoimmune and inflammatory diseases – in an all-stock transaction. ACELYRIN, Inc.,

Biopharma 59

Biopharma Marketing Patients Leads 59

pharmaphorum

SEPTEMBER 7, 2022

Clinical trial results showed a significant reduction in symptoms when people took ozanimod, as compared with a placebo. Clinical experts recommend that TNF-alpha inhibitors be used alongside thiopurines for maximum efficacy. Normally, this is a tumour necrosis factor (TNF)-alpha inhibitor (usually, infliximab).

Side effects 52

Side effects Patients FDA Medical 52

pharmaphorum

OCTOBER 26, 2022

Those who develop psoriatic arthritis are saddled with joint pain and inflammation. Rob Louie RPh is EVP, Clinical Services at RemedyOne, a formulary and rebate optimization company and part of Goodroot, a community of companies reinventing healthcare, one system at a time. All that’s missing is a catchy theme song.

Side effects 91

Side effects Food and Drug Administration Patients Management 91

PM360

JULY 13, 2023

Clinical Educators who deliver top-tier supplemental disease education and treatment administration support, as well as behavioral health skill building and nutrition guidance to patients and their care partners. The RfD Analytics Report directly extracts and categorizes these reasons from the clinical narrative at scale.

Education 89

Education Medical Media Patients 89

MedCity News

NOVEMBER 7, 2023

Ventyx Biosciences is stopping work on its lead drug candidate in plaque psoriasis and psoriatic arthritis. Despite achieving the goals of its Phase 2 test in psoriasis, the results are short of those achieved by big pharmaceutical companies with molecules that address the same target.

Leads 124

Leads Pharmaceutical Biopharma Pharma 124

European Pharmaceutical Review

NOVEMBER 14, 2022

Janssen’s post-hoc analysis for its Phase III programme ( NCT03158285 ) evaluating Tremfya ® (guselkumab), the first fully human selective interleukin (IL)-23 inhibitor for moderate to severe plaque psoriasis (PsO) and adults with active psoriatic arthritis (PsA), predicted longer-term response due to early skin and enthesitis response.

Patients 88

Patients Pharmaceutical 88

PM360

APRIL 25, 2023

As the world’s top-selling biologic drug, with annual sales topping $21 billion, Humira is used to treat a wide range of chronic conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, juvenile idiopathic arthritis, ulcerative colitis, and uveitis.

Marketing 97

Marketing Competition Government Manufacturing 97

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. RaniPill (image courtesy of Rani Therapeutics).

Food and Drug Administration 91

Food and Drug Administration Manufacturing Safety Pharmaceutical 91