XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

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Botox FDA Approval Cosmetics Clinical Trials 98

Pharmaceutical Technology

DECEMBER 5, 2022

Incyte has signed a partnership and licence agreement with CMS subsidiary CMS Aesthetics to develop and market ruxolitinib cream to treat autoimmune and inflammatory dermatologic ailments in Greater China and some Southeast Asian countries. Incyte will also receive royalty payments on the net product sales in the territory of CMS.

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Dermatology FDA Approval Production Sales 130

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 In-Vivo 92

XTalks

JUNE 26, 2024

This condition profoundly impacts patients’ quality of life, affecting work productivity, daily activities, emotional well-being and personal relationships. The approval of Sofdra provides a much needed solution for individuals struggling with this socially and physically debilitating condition.

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Clinical Trials Clinical Trials Dermatology FDA Approval 103

XTalks

MARCH 18, 2025

Standard treatment strategies include combinations of antibiotics, hormonal therapies and biologic agents most notably adalimumab (Humira), the only FDA-approved biologic for moderate to severe cases while surgery remains an option for advanced disease.

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Trials Clinical Trials Clinical Trials Hormones 59

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). As a topical treatment, it is also the first readily redosable gene therapy.

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Gene Therapy Gene Dermatology FDA Approval 97

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Klisyri is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex.

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FDA Approval Development Production Drugs 52

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.

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FDA Approval Production Dermatology Sales 59

XTalks

MAY 25, 2023

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.)

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Filler Life Science FDA Approval Drugs 52

pharmaphorum

FEBRUARY 28, 2022

Amryt has indicated in the past that Oleogel-S10 (formerly AP101) has the potential to become a $1 billion product if approved in the US and Europe. It will take some comfort from fact that it already sells three rare disease therapies and is predicting full-year 2021 sales of $220 to $225 million.

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Drugs Marketing Regulation FDA Approval 98

pharmaphorum

JULY 19, 2022

The FDA has been paying close attention to the safety of JAK inhibitors, and Opzelura was approved with black box warning that includes JAK class-wide wording for risks such as infections, heart-related events and cancer, despite being used on the skin rather than administered systemically.

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Sales FDA Approval Regulation Drugs 98

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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Drugs FDA Approval Licensing Licensing 52

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

The Pharma Data

JANUARY 13, 2021

To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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Clinical Trials Clinical Trials Trials In-Vitro 52

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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FDA Approval Clinical Trials Clinical Trials Trials 40

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. By locally blocking androgens, Winlevi prevents the production of excess oil (sebum) and dampens down inflammation, according to the company.

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Dermatology Drugs Hormones FDA Approval 52

The Pharma Data

FEBRUARY 25, 2022

The PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA).

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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

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. driven by the write-off of $1.5

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Sales Production Antibody Development 52

The Pharma Data

OCTOBER 9, 2021

Currently there are no FDA-approved treatments for EoE. AstraZeneca will record all sales outside of the US as product sales and recognise Amgen’s share of gross profit as cost of sales. Patients are often treated with corticosteroids to manage inflammation.

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Drugs Sales Medicine Dermatology 52

The Pharma Data

DECEMBER 30, 2020

The company has a number of branded products in this space, including Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. Soliris has been approved for paroxysmal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder.

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Antibody Allergies Branding Dermatology 52

Delveinsight

AUGUST 13, 2020

Innoviva is also entitled to 15% of royalty payments made by GSK under its agreements originally entered, and since assigned to Theravance Respiratory Company, LLC relating to TRELEGY ELLIPTA and any other product or combination of products that may be discovered and developed in the future under the LABA (long-acting beta2 agonist) Collaboration.

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Antibody Medicine Trials Development 40

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Immune-Mediated Skin and Dermatologic Adverse Reactions.

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Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Immune-Mediated Skin and Dermatologic Adverse Reactions.

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Trials Hormones 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. Source link: [link].

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Bioequivalency Vaccine Vaccination 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. Skin-related diseases are more than skin deep.

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Dermatology Development Medicine Clinical Trials 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

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Sales Manufacturing FDA Approval Life Science 98

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. Check out this article to learn about the biotech companies that went public this year.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

pharmaphorum

JANUARY 5, 2021

In the near term, launch products, which rely for establishment on new and switch patient opportunities, have, with a few notable exceptions, had a dreadful year. The latest 2020 approval was Orladeyo for hereditary angioedema on 4 December, so there is potential for 2020’s approvals to exceed those of 2019.

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Sales Marketing Production Vaccine 105

The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. Net sales of the top 20 Innovative Medicines products in 2021. . Top 20 products total. New approvals. Adakveo sales reached USD 37 million. Diovan Group. Exjade/Jadenu.

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Sales Medicine Production Manufacturing 40

XTalks

JANUARY 2, 2025

Since its FDA approval in 2017, Regeneron and Sanofi’s Dupixent has been hailed as an innovative treatment for patients with atopic dermatitis, with industry experts describing it as “life-changing.” ” Over the years, Regeneron has expanded Dupixents approved uses, most notably into asthma.

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Sales FDA Approval Drugs Marketing 85

XTalks

DECEMBER 18, 2024

The US Food and Drug Administration (FDA) has granted approval to Checkpoint Therapeutics PD-L1 inhibitor Unloxcyt (cosibelimab-ipdl) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients who cannot be cured with surgery or radiation therapy.

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FDA Approval Antibody Immune Response Marketing 95

Pfizer

OCTOBER 28, 2022

PRAC recommended that risk minimization measures, including special warnings and precautions for use, should be revised for all JAK inhibitors approved in the EU, including XELJANZ® (tofacitinib) and CIBINQO™ (abrocitinib). For the complete EU product information, please visit: [link]. CIBINQO FDA-APPROVED INDICATION.

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