dermatology

FDA clears Incyte’s Opzelura as first vitiligo therapy

Incyte’s Opzelura cream has become the first medical treatment approved to re-pigment the skin of people with vitiligo in the US, adding to its current use in atopic dermatitis. 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 …

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Almirall-backed psoriasis support app Claro launches in Europe

An alliance between Spanish drugmaker Almirall and digital health company Happify has yielded its first fruit, with the launch of their Claro app designed to reduce anxiety and improve wellbeing in people with psoriasis. The web-based app is rolling out first in the UK, Spain and Italy and is aimed at the 20% to 30% …

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FDA grants speedy review to Dupixent rare skin disease

Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN). The US regulator has granted Dupixent (dupilumab) a six-month priority review in PN and is due to deliver a verdict by 30 September, offering patients …

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Third FDA rejection for Verrica’s molluscum contagiosum drug

Shares in US biotech Verrica Pharma lost half their value today after the FDA declined to approve its candidate treatment for viral skin infection molluscum contagiosum for a third time. The problems outlined in the US regulator’s complete response letter (CRL) for VP-102 centre around contract manufacturing organisation (CMO) Sterling Pharmaceuticals Services, which is producing …

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Dermavant claims its first approval as FDA clears psoriasis drug

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. Vtama (tapinarof) – originally developed by GlaxoSmithKline – is a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent …

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Sidekick and Pfizer prep launch of DTx for atopic dermatitis

A long-running partnership between digital therapeutics (DTx) developer Sidekick Health and Pfizer has resulted in a new app to support patients with atopic dermatitis, which will start rolling out in Europe and Japan later this year. Sidekick specialises in developing gamified digital health apps. Its alliance with Pfizer has already led to the launch of …

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Happify says study backs value of its wellbeing app in psoriasis

People with psoriasis who used an app developed by digital health company Happify reported reduced anxiety and improvements in mental wellbeing in a real-world study involving more than two hundred subjects. It’s well recognised that people with psoriasis can develop depression or anxiety, particularly in moderate or severe cases where a sizeable part of the …

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FDA turns down Amryt’s epidermolysis bullosa drug

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). Shares in the Ireland-based rare disease specialist fell sharply after news of the complete response letter (CRL) from the FDA emerged, with the …

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Almirall and IRB Barcelona team up to tackle skin disease

Two Spanish pharma companies are joining forces to identify new oral treatments for immune-inflammatory skin diseases with high unmet medical needs. Almirall and IRB Barcelona (the Institute for Research in Biomedicine), will conduct research using molecular glue degraders, a new approach to the skin diseases under scrutiny. The use of monovalent degraders, which enable the …

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Leo puts target on Dupixent in US as FDA clears tralokinumab

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies. The …

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Boehringer’s spesolimab data raises hope for serious skin disease

Fresh from being awarded a fast-track review from the FDA, Boehringer Ingelheim’s spesolimab has shown encouraging efficacy in a phase 2 trial in generalised pustular psoriasis (GPP), a rare and life-threatening skin disorder. GPP is very different from the more common plaque psoriasis, not least because it causes episodes (flares) of widespread eruptions of painful …

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FDA sets April date for verdict on Incyte’s vitiligo drug

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. The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and …

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Sanofi snaps up acne vaccine developer Origimm Bio

Sanofi has added to its vaccine pipeline with an agreement to acquire Austria’s Origimm Biotechnology and its vaccine-based immunotherapy for people with acne. The French group said that ORI-001, a vaccine based on recombinant proteins from the  Cutibacterium acnes (formerly Propionibacterium acnes) bacterium that is often found in acne lesions, could be the first ever …

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Fishawack Health welcomes expert-led dermatology initiative FIDE to its group

KNUTSFORD, United Kingdom — Fishawack Health welcomes FIDE, an independent organization providing its clients with insight from clinical key opinion leaders in inflammatory dermatology [Image: From left, FIDE Directors Richard GB Langley, MD; Richard Warren, MD, PhD; Kenneth B Gordon, MD; Bruce E Strober, MD, PhD] November 10, 2021, UK. Fishawack Health, the leading commercialization partner …

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Patient and market insights from leading KOLs and life science leaders

Today, there are more than 80 treatments in development for atopic dermatitis and psoriasis. The landscape is booming with treatment innovations. However, the rise in research and development has created a crowded market that healthcare professionals struggle to navigate. Dermatologists face an abundance of data and more complex barriers to access than ever before. These …

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Dupixent scores a first in rare skin disease prurigo nodularis

Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease. The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next …

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Key drug in Sanofi’s $1.45bn Kymab buyout shows promise in eczema

Already a major player in atopic dermatitis with Dupixent, Sanofi looked to expand its position in the category earlier this year when it bought Kymab and its lead drug KY1005 for the skin disorder for $1.1 billion upfront. Now, it says the drug has delivered “exciting” results in a proof-of-concept trial. KY1005 – now renamed …

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Incyte leads JAK push into eczema as FDA clears Opzelura cream

The FDA has approved Incyte’s Opzelura cream for atopic dermatitis, commonly called eczema, becoming the first and only topical JAK inhibitor registered in the US. Opzelura (ruxolitinib) – which has been cleared to treat atopic dermatitis in adolescents and adults whose symptoms cannot be treated using other topical therapies – has beaten its orally-administered rivals …

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Taking a de-centralized approach to cure the Hepatitis C epidemic

This year’s World Hepatitis Day theme, ‘Hepatitis Can’t Wait,’ stresses the urgency of testing and treating viral hepatitis, as well as removing the stigma surrounding the disease and providing support for patients. Treatment for hepatitis C has evolved dramatically over the past decade. The introduction of direct-acting-antivirals has revolutionized the treatment landscape, leading the World …

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IL-17 tailender UCB gets EU OK for bimekizumab in psoriasis

UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it can mount a stiff challenge to the leaders, including Novartis’ big-selling Cosentyx. The European Commission has cleared the drug as Bimzelx for the treatment of moderate to severe plaque psoriasis …

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Look out Dupixent, Lilly’s lebrikizumab is on the march

Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks like it has backed a winner. The company has claimed across-the-board wins against primary and secondary measures of efficacy in the studies, and while the data hasn’t been revealed yet, …

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UCB’s bimekizumab ‘pre-approved’ using NICE fast-track scheme

UCB’s bimekizumab hasn’t been approved for marketing in Europe yet, but has already been given the nod for NHS use in England and Wales under a new fast-track scheme introduced by NICE. The IL-17 inhibitor is the first to go through a new process aimed at accelerating appraisals for drugs deemed to be low-risk, which …

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The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

During the last two decades, the landscape for psoriasis treatment has exploded. The advent of biologic therapies at the turn of the millennium and the subsequent development of T-cell targeted therapies and tumor necrosis factor (TNF) inhibitors have given patients therapeutic options beyond traditional treatments such as topical steroids, tar preparations, oral systemics, and light …

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The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

During the last two decades, the landscape for psoriasis treatment has exploded. The advent of biologic therapies at the turn of the millennium and the subsequent development of T-cell targeted therapies and tumor necrosis factor (TNF) inhibitors have given patients therapeutic options beyond traditional treatments such as topical steroids, tar preparations, oral systemics, and light …

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor Read More »

Almirall kicks off another hunt for skin disease therapy partnerships

Spanish drugmaker Almirall has launched another search for early-stage research projects that it can partner in dermatology, its core area of expertise. The latest edition of its AlmirallShare competition – which will take submissions until 31 October this year – is hunting for innovative therapies for skin diseases that are in the research or preclinical …

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Dermavant raises $200m to ease launch of Otezla rival tapinarof

Dermavant is in line to make some big payments to GlaxoSmithKline if its topical psoriasis drug tapinarof reaches the market, and it has just cut a deal to defray those costs. The Roivant group company has raised $160 million from investors plus a $40 million credit facility that it can draw on if – and …

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Amgen pays Kyowa $400m upfront for OX40 eczema drug

Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa Kirin that is ready for phase 3 testing for atopic dermatitis or eczema.  The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of …

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Incyte preps second filing for ruxolitinib cream after vitiligo trial win

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. Ruxolitinib is a topical Janus kinase (JAK) inhibitor that could provide an alternative to the steroids commonly used to treat these skin conditions, although …

Incyte preps second filing for ruxolitinib cream after vitiligo trial win Read More »

Crowded psoriasis market cuts Lilly’s mirikizumab ambitions

Eli Lilly has walked away from a major indication for its blockbuster hopeful mirikizumab, shelving plans to file it for psoriasis as the market is getting much too congested.  The decision – announced in the company’s first-quarter results statement – comes shortly after Lilly reported positive phase 3 results with mirikizumab in ulcerative colitis. The …

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Avillion/Merck psoriasis nanobody hits the mark in phase 2

UK biotech Avillion has reported positive mid-stage results with chronic psoriasis drug sonelokimab, which it is developing with Merck KGaA as an alternative to drugs like Novartis’ Cosentyx.  The IL-17A and IL-17F inhibitor hit all its objectives in the phase 2 trial, which has now been published in The Lancet, and showed that it was …

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Lilly’s Olumiant is first JAK drug backed by NICE for eczema

Eli Lilly’s JAK inhibitor Olumiant has become the first drug in the JAK inhibitor class to be recommended for NHS use in England and Wales as a treatment for atopic dermatitis, also known as eczema. Olumiant (baricitinib) has been backed by cost-effectiveness agency NICE  to treat moderate to severe atopic dermatitis in adults who haven’t …

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Almirall names Nazzi as new CEO after Guenter leaves for Merck

Spanish drugmaker Almirall has lined up its new CEO following the departure of Peter Guenter, who left to lead Merck KGaA’s healthcare unit earlier this month. Gianfranco Nazzi The new CEO is Gianfranco Nazzi, who will take over at Almirall on 1 May. For the last three years he has served as executive vice president, …

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Almirall, Happify partner on digital tool for psoriasis mental health

It’s well recognised that people with psoriasis can develop depression or anxiety, particularly in moderate or severe cases where a sizeable part of the body can have skin lesions. Now, drugmaker Almirall and digital health firm Happify are working on a tool to support mental health in these patients. Almirall is a specialist in psoriasis …

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Popit and Almirall’s new app tracks adherence to psoriasis med

Finnish startup Popit has joined with Spain’s Almirall to produce an app that tracks whether patients have taken their psoriasis medicine and sends them a reminder if they miss a dose. Popit’s technology, which is available in the Netherlands, is clinically validated to reduce the number of missed doses and has been already used by …

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Popit and Almirall’s new app tracks adherence to psoriasis med

Finnish startup Popit has joined with Spain’s Almirall to produce an app that tracks whether patients have taken their psoriasis medicine and sends them a reminder if they miss a dose. Popit’s technology, which is available in the Netherlands, is clinically validated to reduce the number of missed doses and has been already used by …

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

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 US regulator has started a priority review of abrocitinib for mediate to severe atopic dermatitis …

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FDA hands Cassiopea its first approval, for acne drug Winlevi

Italian biotech Cassiopea has won US approval for Winlevi, a topical therapy it says is the first new approach to treating acne in nearly 40 years. 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 …

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UCB’s IL-17 latecomer bimekizumab beats Cosentyx in psoriasis trial

Belgian biopharma company UCB is bringing up the rear of the IL-17 inhibitor category with its bimekizumab drug, so is celebrating new late-stage data showing superiority to the class leader. The BE RADIANT trial pitted bimekizumab against Novartis’ Cosentyx (secukinumab) in the treatment of adults with moderate-to-severe psoriasis, and according to UCB is the first …

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Novartis takes $485m hit after axing eczema drug from pipeline

Novartis has axed development of its mid-stage eczema drug ZPL389, taking a $485 million hit in the process. Buried deep in the Swiss company’s Q2 results statement, the company said it had discontinued development of the oral H4 receptor antagonist. Novartis added ZPL389, also known as adriforant, to its pipeline with a buyout of UK …

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