Dermatology, FDA Approval and Regulation - Clinical Research Informer

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

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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FDA hands Cassiopea its first approval, for acne drug Winlevi

pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company.

Dermatology

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FDA turns down Amryt’s epidermolysis bullosa drug

pharmaphorum

FEBRUARY 28, 2022

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB).

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FDA clears Incyte’s Opzelura as first vitiligo therapy

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. million people in the US.

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Dermavant claims its first approval as FDA clears psoriasis drug

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

Drugs

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Digital tools driving innovative clinical trials

pharmaphorum

JULY 8, 2022

We have also seen the regulators actively support the use of these hybrid decentralised research approaches. These devices and/or the endpoints they generate are with the rigour required to be submitted to regulators. It needs to be performed with a benchmark, an FDA-approved device.”.

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Incyte leads JAK push into eczema as FDA clears Opzelura cream

pharmaphorum

SEPTEMBER 22, 2021

Its approval for atopic dermatitis was delayed by three months while the regulator completed the safety investigation, which focused mainly on Pfizer’s oral JAK inhibitor Xeljanz (tofacitinib), used to treat arthritis and some other inflammatory diseases.

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FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drug

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.

Drugs

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

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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LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

The Pharma Data

JULY 22, 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.

HR

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Amgen Reports Second Quarter 2021 Financial Results

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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Boehringer bags first approval for rare skin disease drug

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. It is also under review by regulators in Europe, with a decision expected before the end of the year.

Drugs

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Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

(IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Source link.

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Nine for 2021: The COVID-19 legacy

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

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Novartis key growth drivers and launches continue momentum in Q1, maintaining confidence in growth. Group guidance for FY 2021 confirmed. | Novartis

The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. New approvals. Adakveo sales reached USD 37 million. Sandoz sales declined -13% (cc, -9% USD), with Retail -18% (cc) and Biopharmaceuticals growing +7% (cc). Exjade/Jadenu. Entresto. .

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Clinical Research Informer

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

FDA hands Cassiopea its first approval, for acne drug Winlevi

Trending Sources

FDA turns down Amryt’s epidermolysis bullosa drug

FDA clears Incyte’s Opzelura as first vitiligo therapy

Dermavant claims its first approval as FDA clears psoriasis drug

Digital tools driving innovative clinical trials

Incyte leads JAK push into eczema as FDA clears Opzelura cream

FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drug

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Amgen Reports Second Quarter 2021 Financial Results

Boehringer bags first approval for rare skin disease drug

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

Nine for 2021: The COVID-19 legacy

Novartis key growth drivers and launches continue momentum in Q1, maintaining confidence in growth. Group guidance for FY 2021 confirmed. | Novartis

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