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 Register for this free webinar to learn what the FDA’s new draft guidance means for diverse and inclusive trials.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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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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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.

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FDA Approval Clinical Trials Clinical Trials 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

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).

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Gene Therapy Gene FDA Approval Dermatology 97

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.

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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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Dermatology Development Medicine Clinical Trials 52

The Pharma Data

MAY 15, 2023

Positive data from two Phase 3 Dupixent ® (dupilumab) trials in prurigo nodularis published in Nature Medicine Positive results from two Phase 3 Dupixent ® (dupilumab) trials in adults with uncontrolled prurigo nodularis have been published in Nature Medicine. Results from the trials were the basis for the U.S.

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Medicine Trials Dermatology FDA Approval 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.

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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.

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.

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Dermatology Drugs Hormones FDA Approval 52

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

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.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

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

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.

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XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Both trials demonstrated no severe adverse reactions.

FDA Approval 98

FDA Approval Dermatology Clinical Trials Clinical Trials 98

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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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

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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.

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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]).

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Drugs HR FDA Approval Trials 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

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.

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Hormones FDA Approval Doctors Doctor 98

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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Filler FDA Approval Dermatology Production 92

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.

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Sales Regulation FDA Approval Marketing 52

pharmaphorum

OCTOBER 28, 2020

Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts. The partners plan to file for approval of Olumiant in the US and Japan this year.

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Drugs Sales Marketing FDA Approval 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

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84];

HR 52

HR Trials Dermatology Hormones 52

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval 52

FDA Approval Containment Trials Genome 52

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

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.

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Drugs Antibody FDA Approval Trials 105

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

APRIL 4, 2023

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first time an anti-PD-1 therapy has been approved in combination with anantibody-drug conjugate in the U.S. confirmatory trial for the accelerated approval.

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FDA Approval Containment Hormones Dermatology 40

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.

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Trials Development Dermatology 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

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Antibody HR Dermatology Trials 52

The Pharma Data

AUGUST 3, 2021

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S., LUMAKRAS received accelerated approval based on overall response rate and duration of response.

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Sales Production Antibody Development 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.

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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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