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

Safety 57

Safety Medical Patients Medicine 57

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

Food and Drug Administration 80

Food and Drug Administration Medicine Food Patients 80

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.

Food and Drug Administration 52

Food and Drug Administration Medicine Marketing Food 52

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.

Competition 101

Competition Marketing Safety Manufacturing 101

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.

Pharmaceutical 59

Pharmaceutical Pharma Food and Drug Administration Food 59

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.

Food and Drug Administration 105

Food and Drug Administration FDA Sales Food 105

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.

Biopharma 76

Biopharma Manufacturing Medicine Safety 76

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.

Specialization 52

Specialization Consulting Training Networking 52

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.

Food and Drug Administration 98

Food and Drug Administration Medicine FDA Food 98

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.

Medicine 83

Medicine Safety Side effects Patients 83

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.

Medicine 79

Medicine Prospecting Patients Leads 79

Legacy MEDSearch

MARCH 17, 2023

a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company’s device in detecting skin cancer. DermaSensor Inc. , of benign lesions (i.e.,

FDA 52

FDA Physicians Recruitment Medical 52

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.

Recruitment 95

Recruitment Competition Patients Marketing 95

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.

Food and Drug Administration 64

Food and Drug Administration Safety Food Pharmaceutical 64

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.

Food and Drug Administration 52

Food and Drug Administration Management Food Pharmaceutical 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.

Medical 90

Medical Medicine Pharmaceutical Training 90

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

Food and Drug Administration 80

Food and Drug Administration FDA Side effects Medicine 80

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.

Management 73

Management Side effects Patients Safety 73

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.

Prescription 68

Prescription Pharmaceutical products Networking Manufacturing 68

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.

Healthcare 26

Healthcare Healthcare 26

pharmaphorum

SEPTEMBER 8, 2022

Furthering DiME’s previous work on digital clinical measures, nocturnal scratch’s more widespread implementation aims to establish a firmer digital groundwork for future clinical research, technology development, and reimbursement decisions in the dermatological field, and thereby improve the lives of AD patients and caregivers.

Medical 52

Medical Medicine Healthcare Healthcare 52

European Pharmaceutical Review

AUGUST 9, 2023

While injectable biologic therapies are an effective option for CSU that is uncontrolled by these drugs, less than 20 percent of patients worldwide are treated with them, according to a 2016 British Journal of Dermatology paper and research shared by Novartis. In REMIX-2, the clinical trial enrolled 455 participants with CSU.

Safety 72

Safety Medical Patients Pharmaceutical 72

European Pharmaceutical Review

JULY 4, 2023

Janssen’s Phase IIb FRONTIER 1 clinical trial for adult participants achieved all primary and secondary efficacy endpoints, according to topline results showcased by Bissonnette R, Pinter A, Ferris L, et al. at the World Congress of Dermatology 2023.

Patients 73

Patients Pharmaceutical 73

European Pharmaceutical Review

JULY 5, 2022

Clinical outcomes (ie, prevention of HAE attacks in children) were measured as a secondary objective using descriptive statistics. The SPRING study trial results were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022. .

Safety 94

Safety Patients Leads Pharmaceutical 94

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.

Biopharma 89

Biopharma Engineering Consulting Pharma 89

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

pharmaphorum

AUGUST 12, 2022

Patient recruitment specialist Clariness will deploy an app aimed at helping asthma patients monitor environment triggers and report symptoms in the clinical trials its support, thanks to a partnership with digital health firm DailyBreath. The post Clariness, DailyBreath partner to drive recruitment in asthma trials appeared first on.

Recruitment 52

Recruitment Patients Doctors Medical 52

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It operates in New Zealand, Fiji and the US.

Pharmaceutical 40

Pharmaceutical Prescription Manufacturing Medicine 40

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It operates in New Zealand, Fiji and the US.

Pharmaceutical 40

Pharmaceutical Prescription Manufacturing Medicine 40

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Malignant Mesothelioma. 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.

Prescription 40

Prescription Pharmaceutical products Networking Manufacturing 40

Pharmaceutical Technology

MAY 30, 2023

The 2028 forecast blockbuster sales observed for donanemab can be attributed to its advancements in clinical benefits for Alzheimer’s disease, an indication characterized by substantial unmet need. These drugs are set to make a combined $4.34bn in sales in 2028. Similarly, Almirall S.A.,

Sales 105

Sales Marketing Prescription Pharma 105

Pharmaceutical Technology

MARCH 27, 2023

Regenerative medicines in early-stage development (preclinical, discovery, or investigational new drug [IND]/ clinical trial application [CTA] filed status) have seen a change in drug targets compared to therapies in late-stage development (Phase II to pre-registration stage).

Medicine 98

Medicine Marketing Leads 98

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

FEBRUARY 28, 2023

Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase III for Paroxysmal Nocturnal Hemoglobinuria. 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.

Prescription 40

Prescription Pharmaceutical products Networking Pharmaceutical 40

Pharmaceutical Technology

FEBRUARY 28, 2023

Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase III for Glomerulonephritis. 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.

Prescription 40

Prescription Pharmaceutical products Networking Pharmaceutical 40

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

pharmaphorum

SEPTEMBER 30, 2022

Simcere has taken SIM0278 to the brink of clinical testing, and says the drug can be delivered by subcutaneous injection to activate regulatory T cells (Tregs) that have been shown to dampen down inflammatory responses in preclinical disease models. . Last year, Merck & Co paid $1.85

Pharma 52

Pharma Leads Medical Patients 52