European Pharmaceutical Review

APRIL 3, 2023

It relies partly on results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data. This condition is a persistent swelling which does not respond to diuretics and sodium restriction. This medicine was submitted as a hybrid application.

Medicine 85

Medicine Pharmaceutical Marketing Patients 85

Pharmaceutical Technology

MARCH 2, 2023

Rituximab biosimilar is under clinical development by Dr. Reddy’s Laboratories and currently in Phase III for Rheumatoid Arthritis. According to GlobalData, Phase III drugs for Rheumatoid Arthritis have a 65% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.

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European Pharmaceutical Review

NOVEMBER 1, 2022

The proposed restrictions are due to a review of available data, including clinical trial results for Xeljanz and initial findings from an observational study of Olumiant. The PRAC has confirmed that individuals with the following chronic inflammatory disorders should not take JAK inhibitors: Rheumatoid arthritis (RA).

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Side effects Distribution Safety Patients 89

European Pharmaceutical Review

DECEMBER 7, 2023

A world-first clinical trial in type 1 diabetes In the Phase II clinical trial for baricitinib, investigators monitored the blood glucose and insulin production of 91 participants aged between 10 and 30 years old, over a one-year period. 

Management 105

Management Medical Medicine Leads 105

European Pharmaceutical Review

JANUARY 4, 2023

EVOQ Therapeutics Inc has agreed to license its NanoDisc technology for rheumatoid arthritis (RA) and lupus to Gilead Sciences, Inc, enabling EVOQ to potentially receive up $658.5 The companies will collaborate to advance preclinical development and Gilead will be responsible for clinical development and commercialisation.

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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.

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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.

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Consulting Marketing Safety Patients 83

Pharmaceutical Technology

MARCH 1, 2023

It has also been approved in several countries for treating moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have not responded to or tolerated previous therapy. Developed using VelocImmune technology of Regeneron, Kevzara binds to the IL-6 receptor specifically and inhibits IL-6-mediated signalling.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Food and Drug Administration Side effects FDA Medicine 106

Pharmaceutical Technology

FEBRUARY 19, 2023

Annexuzlimab is under clinical development by MedAnnex and currently in Phase I for Kidney Cancer (Renal Cell Cancer). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also provides non-clinical testing programs.

Pharmaceutical 40

Pharmaceutical Patients 40

Pharmacy Times

JUNE 2, 2023

Upadacitinib 15 mg once daily had a better clinical response compared to adalimumab 40 mg every other week at 12 weeks in 3-year follow-up data among patients with rheumatoid arthritis.

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Patients 26

Pharmaceutical Technology

NOVEMBER 1, 2022

These drugs could potentially treat GBA and some inflammatory ailments, including irritable bowel syndrome, inflammatory bowel diseases, rheumatoid arthritis, atopic dermatitis, oligoarticular juvenile idiopathic arthritis and autism spectrum disorder.

Medicine 59

Medicine Safety Specialization Leads 59

European Pharmaceutical Review

MARCH 4, 2024

This growth is accompanied by a substantial number of clinical trials, with close to 20,000 active investigations, involving about 9,500 new biologic treatments. Despite issues of potential toxicity and biocompatibility, several polymers have advanced to clinical trial stages. percent through 2027.

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Food and Drug Administration Transportation FDA Medical 91

European Pharmaceutical Review

SEPTEMBER 20, 2022

Over the past 15 years and the experience from clinical practice has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference products and are therefore interchangeable,” commented EMA’s Executive Director, Emer Cooke.

Medicine 92

Medicine Side effects Safety Doctors 92

Pharmaceutical Technology

MARCH 21, 2023

Gilead Sciences has exercised its option to exclusively license the investigational targeted protein degrader development candidate, NX‑0479, from clinical-stage biopharmaceutical company Nurix Therapeutics. The company stated that the degradation of IRAK4 can help treat rheumatoid arthritis (RA), as well as other inflammatory diseases.

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Sales Patients 52

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-1570 is under clinical development by Astellas Pharma and currently in Phase II for Metastatic Melanoma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pharma 52

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-1570 is under clinical development by Astellas Pharma and currently in Phase II for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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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.

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Safety Patients Pharmaceutical 52

Pharmaceutical Technology

NOVEMBER 10, 2022

The regulatory agency granted EUA based on findings from the double-blind, randomised, controlled Phase III SAVE-MORE clinical trial of Kineret. In the country, Kineret is intended for lowering signs and symptoms and slowing structural damage progression in patients with moderately to severely active rheumatoid arthritis (RA).

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Pharmaceutical Technology

FEBRUARY 27, 2023

Hydrocortisone is under clinical development by Antares Pharma and currently in Phase I for Adrenal Insufficiency. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also develops products to reduce the risk of preterm birth in pregnant women.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-1570 is under clinical development by Astellas Pharma and currently in Phase II for Non-Small Cell Lung Carcinoma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pharma 52

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Pharmaceutical Technology

JANUARY 4, 2023

Gilead Sciences has entered a collaboration and licensing agreement with EVOQ Therapeutics to advance the latter’s technology and develop immunotherapies to treat rheumatoid arthritis (RA) and lupus. Under the deal terms, the two companies will work together to advance the preclinical development of RA and lupus immunotherapies.

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Medicine Sales Pharmaceutical Patients 52

World of DTC Marketing

MARCH 17, 2021

of AbbVie, told a congressional hearing that his pay was tied to the price of the company’s drug for rheumatoid arthritis and other conditions. They need to be extensively tested in long and expensive clinical trials. One company AbbVie has used the courts to stop competition of its top drug Humira.

Pharma 186

Pharma Competition Prescription Doctors 186

European Pharmaceutical Review

AUGUST 11, 2022

“All three of the medications work in different ways, so it makes sense that you [would] get added therapeutic benefit by combining them,” commented Maria Cardinale-King, a Clinical Assistant Professor at the Rutgers Ernest Mario School of Pharmacy and a Clinical Specialist at Saint Peter’s University Hospital.

Food and Drug Administration 76

Food and Drug Administration Patients Medical Food 76

pharmaphorum

OCTOBER 27, 2022

GSK has said it will not be able to move ahead with regulatory filings for otilimab as a treatment for rheumatoid arthritis (RA), after it failed to show the desired level of efficacy in two phase 3 trials. The post GSK shelves arthritis blockbuster hope otilimab after lacklustre data appeared first on.

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Side effects FDA Patients Sales 73

pharmaphorum

JANUARY 4, 2023

The agreement – which focuses on autoimmune diseases lupus and rheumatoid arthritis (RA) – comes almost two years after EVOQ penned a $240 million deal with Amgen that also focused on using the NanoDisc platform for autoimmune disorder therapies. The post Gilead adds lupus, arthritis therapies with EVOQ alliance appeared first on.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-3082 is under clinical development by Astellas Pharma and currently in Phase I for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pharma 40

Pharma Networking Manufacturing Pharmaceutical 40

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-3082 is under clinical development by Astellas Pharma and currently in Phase I for Metastatic Colorectal Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pharma 40

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Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 2 clinical trials, of which 1 was completed, and 1 is ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. The drug candidate is administered through intravenous or subcutaneous route.

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PM360

OCTOBER 13, 2023

HCPs therefore turn to resources not pharma-associated for identifying treatment options, drug-related information, and clinical trial updates. One HCP participant commented on pharma content: “They will often provide clinical trial information, and although I think the data’s correct, it’s presented in a way that is maybe skewed.

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Healthcare Healthcare Doctors Pharma 59

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. The post Santhera seeks speedy FDA review of Duchenne drug vamorolone appeared first on.

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Pharmaceutical Technology

FEBRUARY 18, 2023

According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

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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).

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Side effects Patients FDA Medical 52

Pharmaceutical Technology

FEBRUARY 24, 2023

This point is illustrated by Galapagos’s recent announcement that Jyseleca (filgotinib maleate), the Janus kinase inhibitor (JAKi) being evaluated as a treatment for adults with moderate to severe CD, did not meet its co-primary endpoint of clinical remission and endoscopic response in its two induction studies.

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European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.”

Food and Drug Administration 107

Food and Drug Administration Side effects Pharmaceutical Leads 107

European Pharmaceutical Review

OCTOBER 20, 2022

In this article, Sangamo Therapeutics’ Chief Scientific Officer, Jason Fortenot, explains why CAR Tregs may become transformational therapeutics for immune-mediated diseases, highlighting the challenges his company has overcome to get the first ever engineered Treg therapy into clinical trials. Supporting evidence.

Engineering 125

Engineering Side effects Manufacturing Patients 125

pharmaphorum

OCTOBER 11, 2022

It is subject to a two-year clinical stopping rule, as for now it remains uncertain the benefits of the regimen extend beyond that timepoint and whether continuing to give it will remain cost-effective, according to the SMC’s assessment document.

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Medicine Patients Leads Marketing 52