XTalks

MAY 31, 2022

XTALKS WEBINAR: All Means All: The Road to Inclusivity in Clinical Trials. Register for this free webinar to learn what the FDA’s new draft guidance means for diverse and inclusive trials. Clinical Trials of Vtama. At Dermavant, we are committed to advancing novel, patient-focused innovation in immuno-dermatology.

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FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

APRIL 17, 2023

In clinical trials, patients experienced significantly clearer skin and less interference with sleep due to itch when taking lebrikizumab compared to placebo. The ADvocate1 and ADvocate2 Phase III studies were published in the New England Journal of Medicine and the British Journal of Dermatology , respectively.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. New sensor technology revolutionising data collection.

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Clinical Trials Clinical Trials Trials Regulation 100

XTalks

SEPTEMBER 30, 2024

Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024, the study highlighted significant improvements in key disease markers, positioning orismilast as a potential breakthrough in atopic dermatitis management.

Clinical Trials 98

Clinical Trials Clinical Trials Dermatology Trials 98

XTalks

JUNE 26, 2024

The approval of Sofdra provides a much needed solution for individuals struggling with this socially and physically debilitating condition. Hyperhidrosis is the third most prevalent dermatological condition in the US, affecting roughly 15.3 million people, following acne and atopic dermatitis.

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Clinical Trials Clinical Trials Dermatology FDA Approval 103

XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

Gene Therapy 97

Gene Therapy Gene FDA Approval Dermatology 97

The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. Source link: [link]

FDA Approval 40

FDA Approval Dermatology Clinical Trials Clinical Trials 40

pharmaphorum

MAY 18, 2021

Incyte has made further progress with its ruxolitinib cream, notching up a phase 3 trial showing it can re-pigment skin in vitiligo ahead of a key FDA decision in atopic dermatitis. The post Incyte preps second filing for ruxolitinib cream after vitiligo trial win appeared first on.

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Trials Dermatology FDA Approval Medicine 52

The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. INDIANAPOLIS , Oct.

Dermatology 52

Dermatology Development Medicine Clinical Trials 52

pharmaphorum

DECEMBER 15, 2021

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. Incyte has also filed for approval of Opzelura as a treatment for vitiligo in Europe, with a decision also due in 2022.

Drugs 111

Drugs FDA Approval Sales Manufacturing 111

Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S., Patients were allowed to switch treatment if they deteriorated during the trial.

FDA Approval 40

FDA Approval Clinical Trials Clinical Trials Trials 40

XTalks

JULY 31, 2024

Leqselvi’s approval is based on data from two Phase III clinical trials, THRIVE-AA1 and THRIVE-AA2, which together enrolled over 1,200 patients. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

pharmaphorum

SEPTEMBER 2, 2022

Spevigo is the first approved therapy for GPP, and the first drug in the IL-36 inhibitor class to make it through development and onto the market. “We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares,” he said.

Drugs 105

Drugs Antibody FDA Approval Trials 105

XTalks

SEPTEMBER 22, 2022

On September 1, 2022, Boehringer Ingelheim Pharmaceuticals announced in a press release that the US Food and Drug Administration (FDA) approved Spevigo (spesolimab-sbzo) intravenous injections for GPP flares in adults. Spevigo is the first approved treatment option for GPP in adults. Clinical Trial Behind Spevigo.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Dermatology 52

pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

Dermatology 52

Dermatology Drugs Hormones FDA Approval 52

XTalks

JANUARY 12, 2024

Last summer, Verrica Pharmaceuticals’ topical Ycanth (cantharidin) received FDA approval as the first treatment for molluscum contagiosum. Zelsuvmi’s future was also in question after the drug had failed in two of Novan’s Phase III trials. However, less than six months later, Ligand’s gamble paid off with an approval.

FDA Approval 64

FDA Approval Trials Clinical Trials Clinical Trials 64

pharmaphorum

DECEMBER 1, 2021

Sanofi said it would also apply its mRNA vaccine platform – acquired along with Translate Bio earlier this year – to find other acne vaccine candidates that could start clinical trials in 2023. Origimm’s expertise in the skin microbiome and antigen discovery will be central to that effort, it added.

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Vaccination Vaccine Development Hormones 105

XTalks

SEPTEMBER 5, 2024

percent ruxolitinib, a topical Janus kinase (JAK) inhibitor, is US Food and Drug Administration (FDA)-approved for the treatment of mild to moderate atopic dermatitis in patients 12 years and older. The initial FDA approval for atopic dermatitis paved the way for the 2022 FDA approval for vitiligo.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Containment 52

XTalks

SEPTEMBER 24, 2024

In a major development for those battling moderate-to-severe atopic dermatitis, the US Food and Drug Administration (FDA) approved Eli Lilly’s Ebglyss (lebrikizumab-lbkz). The FDA approval is based on data gathered in three pivotal Phase III clinical trials: ADvocate 1, ADvocate 2 and ADhere.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

XTalks

NOVEMBER 7, 2024

Emrosi’s approval was based on data from a pair of Phase III clinical trials for the treatment of rosacea. The trials met all co-primary and secondary endpoints, with participants having successfully completed the 16-week treatment with no significant safety issues.

FDA Approval 105

FDA Approval Dermatology Bacteria Clinical Trials 105

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

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Clinical Trials Clinical Trials Trials In-Vitro 52

The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. associate professor of Dermatology at Yale School of Medicine. AA is the second potential treatment indication in dermatology for baricitinib after AD. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm 3 were reported in Olumiant clinical trials.

Trials 52

Trials Development Dermatology Clinical Trials 52

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Source link: [link].

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

pharmaphorum

OCTOBER 26, 2022

Food and Drug Administration approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist and the first FDA-approved steroid-free topical medication in its class. Two months later, Arcutis won approval for its Zoryve (roflumilast) cream. First in class. In May, the U.S. Both are once-a-day treatments.

Hormones 98

Hormones FDA Approval Doctors Doctor 98

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study.

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

The Pharma Data

AUGUST 22, 2021

Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3 to 13.9]).

Drugs 52

Drugs HR FDA Approval Trials 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

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Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 18, 2022

Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 1 The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).1,2 months (95% Confidence Interval [CI]: 6.4

Antibody 52

Antibody HR Trials Dermatology 52

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 Dermatologic Adverse Reactions 7. of patients.

FDA Approval 52

FDA Approval Dermatology Genetics Development 52

pharmaphorum

SEPTEMBER 22, 2021

FDA approval for Opzelura is based on data from the TRuE-AD 1 and TRuE-AD 2 trials, which showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura twice daily compared to a non-medicated placebo cream.

Sales 52

Sales Regulation FDA Approval Marketing 52

XTalks

OCTOBER 24, 2024

In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. In this blog, we break down some of the latest innovations in psoriasis treatment, including biosimilars, AI-driven diagnostics and the growing role of family care.

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Research Dermatology Clinical Trials Clinical Trials 105

The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm 3 were reported in Olumiant clinical trials. About Lilly in Dermatology.

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Drugs Dermatology Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. ” The U.S.

Bioequivalency 52

Bioequivalency Vaccination Vaccine Medicine 52

The Pharma Data

MARCH 11, 2021

In 2017, Opdivo was granted accelerated approval by the FDA as a single agent for patients with HCC who have been previously treated with sorafenib. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JULY 23, 2021

Opdivo was first granted this indication in 2017 under the FDA’s accelerated approval program, making it the first immunotherapy agent to be approved for use in this setting. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial.

Hormones 52

Hormones Trials Genome Genomics 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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Sales Manufacturing FDA Approval Life Science 98