XTalks

AUGUST 2, 2023

Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.

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Life Science FDA Approval Dermatology Pharmacy 52

XTalks

MARCH 18, 2025

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. Janus kinase one (JAK1) plays a central role in the signaling pathways of several inflammatory cytokines.

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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.

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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.

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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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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]

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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.

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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., Credit: Octapharma. PARAMUS, N.J. – The U.S. 1, 2, 3, 4. Original Source.

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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.

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Immune Response Dermatology Clinical Trials Clinical Trials 105

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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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.

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FDA Approval Clinical Trials Clinical Trials Dermatology 52

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.

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XTalks

JANUARY 12, 2024

Last summer, Verrica Pharmaceuticals’ topical Ycanth (cantharidin) received FDA approval as the first treatment for molluscum contagiosum. The FDA’s approval of Zelsuvmi was based on data from two Phase III clinical trials, B-SIMPLE 4 and B-SIMPLE 2, involving 1,598 patients.

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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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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.

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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.

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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. . Almirall S.A.’s

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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.

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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 22, 2021

3 “Nivolumab provides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate -274, and has the potential to become a new standard of care option in this setting.” Galsky,* M.D., 1 Please see Important Safety Information below.

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The Pharma Data

MARCH 4, 2021

This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s). Increases of ALT ?5x

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Trials Development Dermatology Clinical Trials 52

XTalks

OCTOBER 24, 2024

Amgen’s Otezla (apremilast) continues to expand its reach, with the US Food and Drug Administration (FDA) approving its use for children and adolescents with moderate to severe plaque psoriasis in 2024. This drug may significantly improve psoriasis care by offering effective long-term control with fewer side effects.

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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.

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The Pharma Data

JULY 23, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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Trials Hormones Genome Genomics 52

The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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Trials Hormones Clinical Trials Clinical Trials 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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The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

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XTalks

JUNE 17, 2024

RELATED: Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics – Xtalks Life Science Podcast Ep. 134 How Does Letybo Work?

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FDA Approval Marketing Botox Clinical Trials 52

XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. A significant percentage of patients also reported reduced sleep disturbances by Week 16 in both clinical trials.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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XTalks

DECEMBER 14, 2023

The US Food and Drug Administration (FDA) has approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have had at least a partial response to previous multiagent, multimodality therapy including anti-GD2 immunotherapy.

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FDA Approval Dermatology Drugs DNA 52

pharmaphorum

FEBRUARY 28, 2022

There are currently no FDA-approved treatment options for EB, a rare group of inherited disorders characterised by extremely fragile skin that blisters and tears from even minor friction or trauma. pic.twitter.com/NzhGx1q1o8. — debra of America (@debraOfAmerica) February 28, 2022.

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XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. There has been significant growth in the number of registered clinical trials globally, with a focus on interventional studies.

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Life Science Clinical Trials Clinical Trials FDA Approval 59

The Pharma Data

APRIL 4, 2023

Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Nephritis resolved in 56% of the 9 patients.

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FDA Approval Containment Hormones Dermatology 40

pharmaphorum

JANUARY 5, 2021

An IQVIA survey to Neurology, Cardiology, Rheumatology, Dermatology and Ophthalmologists in June 2020 across the lead five European countries showed an average of 30% of patients either “no shows” or still waiting for treatment that was delayed.

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