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 Register for this free webinar to learn what the FDA’s new draft guidance means for diverse and inclusive trials.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. Live and On-Demand: Tuesday, July 12, 2022, at 11am EDT (4pm BST/UK).

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

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.

Life Science 52

Life Science FDA Approval Dermatology Pharmacy 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.

Research 105

Research Dermatology Clinical Trials Clinical Trials 105

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

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

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.

Clinical Trials 103

Clinical Trials Clinical Trials Dermatology FDA Approval 103

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?

FDA Approval 52

FDA Approval Marketing Botox Clinical Trials 52

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.

Filler 92

Filler FDA Approval Dermatology In-Vivo 92

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Production 69

Production Clinical Development Development Regulation 69

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

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

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.

FDA Approval 40

FDA Approval Clinical Trials Clinical Trials Trials 40

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.

FDA Approval 52

FDA Approval Development Production Drugs 52

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

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

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.

Vaccine 101

Vaccine Vaccination Development Hormones 101

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.

FDA Approval 64

FDA Approval Trials Clinical Trials Clinical Trials 64

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

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.

Drugs 98

Drugs Marketing Regulation FDA Approval 98

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 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

OCTOBER 31, 2024

Currently offered in clinical trials across hospitals and diagnostic centers, iNav has shown promise in reducing diagnosis-to-treatment times. As the first AI-driven tool for skin cancer detection at the point of care, it enhances dermatology practice efficiency and patient safety.

Dermatology 105

Dermatology FDA Approval Trials Clinical Trials 105

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.

FDA Approval 52

FDA Approval Dermatology Drugs DNA 52

The Pharma Data

MAY 15, 2023

Results from the trials were the basis for the U.S. Food and Drug Administration (FDA) approval of Dupixent in September 2022 and the European Medicines Agency approval of Dupixent in December 2022. Dupixent is the only approved biologic indicated for prurigo nodularis in the U.S. Gil Yosipovitch, M.D.

Medicine 40

Medicine Trials Dermatology FDA Approval 40

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

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

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

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.

Drugs 52

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.

Drugs 52

Drugs HR FDA Approval Trials 52

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

Trials 52

Trials Development Dermatology Clinical Trials 52

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.

Sales 105

Sales Marketing Production Vaccination 105

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 Vaccine Vaccination Medicine 52

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.

Hormones 52

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.

Trials 52

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.

Trials 52

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.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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.

Trials 52

Trials Hormones Clinical Trials 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.

Drug Delivery Systems 111

Drug Delivery Systems Dermatology Drug Delivery Antibody 111