dermatology

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 …

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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 …

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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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