Express Pharma

OCTOBER 5, 2023

The NDA filing for deuruxolitinib with the US FDA is based on two pivotal Phase III trials (THRIVE-AA1 and THRIVE-AA2), which included over 1200 patients across more than 135 clinical trial sites. The presentations highlighted the consistent and high-level efficacy with deuruxolitinib at the 8 mg dose in both Phase 3 trials.

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Pharmaceutical Business Review

OCTOBER 20, 2023

PCI will be responsible for the formulation, packaging, and distribution of a siRNA-based investigational injectable treatment for inflammatory dermatological conditions. More than 900 million people worldwide suffer from dermatological diseases. The organisation will carry out all these activities at its facility located in San Diego.

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Packaging 52

European Pharmaceutical Review

NOVEMBER 17, 2023

Almirall has licensed the rights to develop and commercialise lebrikizumab for the treatment of dermatology indications in Europe. The Phase III clinical development programme, which involved some 1,300 patients, also evaluated the safety profile of lebrikizumab. EC approval was based on three pivotal Phase III studies.

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Hospitals 86

Board Vitals - Pharmacist

NOVEMBER 19, 2022

Are you ready for the American Board of Dermatology board exams? This exam consists of 300 multiple-choice questions (MCQ) that tests candidate’s knowledge of the basic science and clinical aspects of dermatology. Get started with your Dermatology board review today with 10% off the BoardVitals Dermatology question bank.

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ALiEM - Pharm Pearls

JANUARY 8, 2024

Copyright Images and cases from the Society of Academic Emergency Medicine (SAEM) Clinical Images Exhibit at the 2023 SAEM Annual Meeting | Copyrighted by SAEM 2023 – all rights reserved. View other cases from this Clinical Image Series on ALiEM.

Hospitals 150

Hospitals 150

European Pharmaceutical Review

MAY 8, 2024

The clinical trial is evaluating the mAb IMG-007 in adults with moderate-to-severe atopic dermatitis who have inadequate response to and/or intolerant of topical therapies, include severity index (EASI) over time, according to Inmagene. What did the interim data for IMG-007 demonstrate?

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Express Pharma

MAY 1, 2023

The US Food and Drug Administration (FDA) has asked Sun Pharmaceutical Industries to stop trials on one dose of a dermatological drug due to the potential of blood clots, informed a company statement. The post US FDA asks Sun Pharma to stop trial on dermatological drug citing potential of blood clots appeared first on Express Pharma.

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European Pharmaceutical Review

MARCH 13, 2024

In the long-term extension FRONTIER 2 study , JNJ-2113 demonstrated sustained efficacy from Week 16 to Week 52, based on data presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting. Johnson & Johnson stated that JNJ-2113 is the first targeted oral peptide designed to block the IL-23 receptor. at 16 weeks and 76.2

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Pharmafile

MARCH 31, 2023

ALM) , a global biopharmaceutical company focused on medical dermatology, announced today the publication of Week 16 and Week 52 results of ADvocate1 and ADvocate2 by the New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD), respectively. March 31, 2023 – Almirall, S.A. read more

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pharmaphorum

NOVEMBER 11, 2021

KNUTSFORD, United Kingdom — Fishawack Health welcomes FIDE, an independent organization providing its clients with insight from clinical key opinion leaders in inflammatory dermatology. Kenneth B Gordon, MD, Professor and Chair of Dermatology at the Medical College of Wisconsin. November 10, 2021, UK. Visit us at ? About FIDE.

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Pharmaceutical Business Review

DECEMBER 13, 2023

The alliance brings together and leverages etherna’s mRNA capabilitie s and LNP formulations with Almirall’s expertise in medical dermatology to speed up the discovery of new treatment options. The two companies will work together on the research activities, with Almirall leading clinical development and commercialisation.

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Pharmafile

MARCH 30, 2023

Granular has now commenced proof-of-concept (POC) and IND-enabling studies as it prepares for clinical development. Granular has now commenced proof-of-concept (POC) and IND-enabling studies as it prepares for clinical development. read more

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European Pharmaceutical Review

APRIL 26, 2024

AbbVie stated that the observed safety profile for upadacitinib in the Phase IIIb/IV trial was consistent with those in previous upadacitinib atopic dermatitis clinical studies. Patients treated with upadacitinib: Achieved EASI 90 at Week 16 (40.8 percent vs 22.5 percent) Achieved a WP-NRS of 0/1 at Week 16 (30.2 percent vs 15.5

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Labelling 87

European Pharmaceutical Review

APRIL 26, 2024

It is approved for autoimmune disorders within disease areas such as gastroenterology and dermatology. Pyzchiva was developed and registered by Samsung Bioepis to match the reference medicine.

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Biosimilars Packaging Pharmaceutical Companies Pharmaceutical Companies 88

European Pharmaceutical Review

APRIL 27, 2023

Clinical trial data for Cosentyx The study data is based on two trials in the largest Phase III programme in HS: SUNSHINE and SUNRISE. The full results were recently published in The Lancet. “If

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Medical Schools 82

Pharmaceutical Technology

JANUARY 19, 2023

Concert’s patent portfolio includes oral Janus kinases JAK1/2 inhibitor, deuruxolitinib, to treat Alopecia Areata, an autoimmune dermatological disease. Deuruxolitinib’s safety and efficacy was assessed in moderate to severe Alopecia Areata adult patients in the THRIVE-AA Phase III clinical programme.

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Labelling 59

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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Biosimilars Immunity Immunization 103

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 Biosimilars Immunity 105

Pharma Mirror

SEPTEMBER 16, 2022

Barcelon, a global biopharmaceutical company focused on skin health, announced at the 31st EADV (European Association of Dermatology and Venereology) Congress the results from TRIBUTE, an interventional phase IV clinical study, which resembled real-life clinical practice. In this study, Ilumetri®?

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Pharmaceutical Business Review

NOVEMBER 20, 2023

Furthermore, the Phase III clinical development programme assessed the safety profile of lebrikizumab. The company has licensed the rights for the development and commercialisation of lebrikizumab to treat dermatological conditions, such as atopic dermatitis, in Europe.

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pharmaphorum

JULY 5, 2022

With more than 500 dermatology clinical trials currently underway, it is often heard that there is a ‘’competition for participants’’. Instead, atopic dermatitis clinical trial organisers often simply only reach out to a limited patient population and fail to reach the complete, diverse, patient population of atopic dermatitis.

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Communication 115

ALiEM - Pharm Pearls

DECEMBER 4, 2023

Journal of the American Academy of Dermatology, 67(6), e253–e260. Copyright Images and cases from the Society of Academic Emergency Medicine (SAEM) Clinical Images Exhibit at the 2023 SAEM Annual Meeting | Copyrighted by SAEM 2023 – all rights reserved. View other cases from this Clinical Image Series on ALiEM.

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Hospitals Medical Schools Diabetes 150

pharmaphorum

AUGUST 17, 2022

At Fishawack Health (FH), we are committed to investing in the field of dermatology. In November 2022, we welcomed FIDE , an independent network of expert partners in dermatology, to inform industry specialists as to the potential impact of the latest data and how it may affect their strategic decision-making.

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European Pharmaceutical Review

SEPTEMBER 11, 2023

Clinical evidence for SB17 Phase I results presented by Samsung Bioepis at the American Academy of Dermatology (AAD) Annual Meeting, in March 2023 demonstrated that SB17 matches the pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity of ustekinumab.

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Biosimilars 78

pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. However, side effects do happen.

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Medical Schools Hospitals Dosage Labelling 99

European Pharmaceutical Review

DECEMBER 15, 2022

The primary endpoint in both trials evaluated the proportion of patients with clinically meaningful improvement in itch from baseline (measured by a ≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] on a 0-10 scale) at 24 and 12 weeks, respectively. Phase III trial data that formed the basis of the EC’s approval.

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Hospitals 85

European Pharmaceutical Review

MAY 24, 2023

Results from the clinical trials for the redosable gene therapy The redosable gene therapy is the first and only medicine approved by the FDA for the treatment of DEB, both recessive and dominant” The FDA approval of VYJUVEK is based on two clinical studies: the GEM-1/2 trial and GEM-3 trial.

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Pharma in Brief

JANUARY 15, 2024

The Federal Court ( FC ) has refused to overturn a decision of the Patented Medicine Prices Review Board ( PMPRB or Board ) that found that a patent can pertain to a medicine based on “clinical similarities” to the invention—even if the patent does not actually encompass the medicine. Background This case concerns Canadian Patent No.

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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.

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Pharmaceutical Technology

JULY 12, 2022

A validated target in dermatology, PDE4 is an enzyme that induces overactive immune responses. The NDS submission by Arcutis is based on positive findings from the company’s pivotal Phase III programme and two long-term open-label clinical trials. Health Canada has provided a target action date of 30 April next year.

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Labelling Immunity Immunization 64

Pharmacy Times

OCTOBER 27, 2022

Strengthening partnerships with healthcare professionals and driving awareness on the clinical benefits of dermatological skincare is the key to success in the public health space.

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Pharma Mirror

MARCH 27, 2022

BME: ALM) announced today at the American Academy of Dermatology (AAD) Annual Meeting. Lebrikizumab, an investigational IL-13 inhibitor, also led to clinically meaningful improvements in itch and other important patient-reported outcomes compared to placebo.

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Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. The company will help in managing the clinical trials of the products once the regulators provide approvals for the proposed research and development programmes.

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Immunity Immunization Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 7, 2022

” Since September 2021, Dr Hughes has been Senior Vice President of Clinical Development and Translational Medicine at Vertex Pharmaceuticals, based in Boston. Prior to that, he was Head of the Immunology, Hepatology & Dermatology Global Development Unit at Novartis.

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Research Laboratories Pharmaceutical Companies Pharmaceutical Companies Hospitals 92

RX Note

JUNE 30, 2023

In outpatient pharmacy , we receive prescriptions from various clinics within the hospital, including general medical, surgical, ophthalmology, dermatology, rheumatology, paediatrics, neurology, nephrology and more. Last month, we received a prescription from the geriatric clinic for donepezil 20 mg tablet once daily.

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Labelling Dosage Hospitals Medical Compliance 40

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers generic medicines and biosimilars through Sandoz.

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Generic Medicine Biosimilars Immunity Immunization 68

European Pharmaceutical Review

FEBRUARY 9, 2023

If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica. Larger clinical trials are needed to better assess the efficacy and safety of difelikefalin in notalgia paresthetica. points in patients receiving difelikefalin versus 2.4

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