XTalks

APRIL 17, 2023

These results are very promising for patients with atopic dermatitis,” said Jonathan Silverberg, MD, professor of dermatology at George Washington University School of Medicine & Health Sciences and co-investigator of the studies, in the company’s press release. Dupixent inhibits signaling of both IL-4 and IL-13.

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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

Initially, these lines might only be noticeable during specific facial expressions in youth, but over time, the surrounding tissue may develop persistent wrinkles. Developed by Revance Therapeutics, Daxxify stands out for its composition, which is devoid of both human serum albumin and animal-based components.

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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 Dermatology FDA Approval 97

XTalks

JUNE 26, 2024

Sofdra’s approval offers a novel treatment option for both adults and children aged nine and older, addressing a condition that affects approximately 10 million people in the US who have had limited effective treatments available. Hyperhidrosis is the third most prevalent dermatological condition in the US, affecting roughly 15.3

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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. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. BUFFALO, N.Y.,

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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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Clinical Trials Clinical Trials Dermatology Trials 98

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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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

NOVEMBER 2, 2023

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis. This gives it a significant edge over a simple biosimilar designation.

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FDA Approval Production Dermatology Sales 59

XTalks

JULY 31, 2024

Leqselvi Is a New Option for Patients This development is particularly exciting for patients who have been frustrated with the limited treatment options available.

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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. In 2019, Ligand had given Novan funding to develop the drug in exchange for milestones and royalties but ended up acquiring it outright through the 2023 buyout.

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pharmaphorum

MAY 18, 2021

It’s the same active ingredient that is used in Incyte/Novartis Jakafi/Jakavi, which is FDA approved in oral form for myelofibrosis, polycythemia vera and graft-versus-host-disease. Over-activity of the JAK signalling pathway has been shown to drive the inflammation that causes vitiligo and drives its progression.

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Trials Dermatology FDA Approval Medicine 52

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. A variety of digital and sensor technologies have been developed for use in clinical trials to allow the collection of high-quality, reproducible data and provide trialists with real-time insights (Table 1).

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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

pharmaphorum

OCTOBER 26, 2022

Those who develop psoriatic arthritis are saddled with joint pain and inflammation. 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. First in class. In May, the U.S. Both are once-a-day treatments.

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pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. Otezla – which Amgen acquired for $13.4

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XTalks

AUGUST 7, 2024

Related: New Sotyktu Commercial for Plaque Psoriasis: Living Life Without a “Filter” Treatments for Psoriasis Over the years, advancements in medical research have led to the development of more effective treatments for psoriasis. In June, it received expanded approval for ulcerative colitis.

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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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FDA Approval Dermatology Genetics Development 52

The Pharma Data

MARCH 27, 2022

Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. associate professor of dermatology at Yale School of Medicine and lead author of these analyses. “In 2022, OLUMIANT could become the first medicine ever approved to treat adults with alopecia areata.

Dermatology 40

Dermatology Medicine Licensing Licensing 40

XTalks

JUNE 10, 2024

Sotyktu (deucravacitinib) is a one-of-its-kind oral medication approved by the US Food and Drug Administration (FDA) indicated to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a sentiment that heavily resonates within the psoriasis community. What Is Sotyktu?

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Immune Response Dermatology Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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The Pharma Data

JUNE 7, 2022

vice president of global immunology development and medical affairs at Lilly. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” About Lebrikizumab.

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Trials Clinical Trials Clinical Trials Medicine 40

Roots Analysis

JANUARY 3, 2024

However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002. Afterwards, in 2003, the FDA approved Hyaluronic Acid Fillers (HA dermal fillers), bringing the much-anticipated innovation to all types of face and non-face augmentation products.

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Filler Cosmetics Production Dermatology 40

pharmaphorum

DECEMBER 1, 2021

Last year, the FDA approved a new topical hormonal therapy – Cassiopea’s androgen receptor inhibitor Winlevi (clascoterone) – which became the first new drug for acne in nearly 40 years. The post Sanofi snaps up acne vaccine developer Origimm Bio appeared first on. Photo by Scott Webb on Unsplash.

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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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.

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Dermatology Drugs Hormones FDA Approval 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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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

OCTOBER 9, 2021

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US.

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Drugs Sales Medicine Dermatology 52

The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

FDA Approval 52

FDA Approval Production Medicine Dermatology 52

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. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

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FDA Approval Antibody DNA Hormones 52

The Pharma Data

MAY 15, 2023

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. Results from the trials were the basis for the U.S. Gil Yosipovitch, M.D.

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The Pharma Data

DECEMBER 30, 2020

billion acquisition of Germany-based Myr GmbH, a company focused on developing therapies for treatment of chronic hepatitis delta virus (HDV), the most severe form of viral hepatitis. AstraZeneca Dives into Rare Diseases: AstraZeneca has been in the spotlight for the COVID-19 vaccine candidate it developed with Oxford University.

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The Pharma Data

MARCH 18, 2022

While we have made great progress in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients,” said Samit Hirawat, chief medical officer, global drug development, Bristol Myers Squibb.3 1 Please see Important Safety Information below.

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The Pharma Data

MARCH 23, 2021

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. 1] as determined by an FDA-approved test.

HR 52

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The Pharma Data

AUGUST 3, 2021

billion in acquired in-process research & development (acquired IPR&D) associated with our acquisition of Five Prime Therapeutics, partially offset by increased revenues. We expect that recovery in the dermatology segment will continue to progress over the coming quarters. GAAP earnings per share (EPS) decreased 73% to $0.81

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