The Johnson & Johnson subsidiary Janssen has announced positive top-line results from its Phase IIb FRONTIER 1 trial of the first and only oral interleukin-23 receptor (IL-23R) antagonist peptide, JNJ-2113, in moderate-to-severe plaque psoriasis. 5 July 2023
German family-owned pharma major Boehringer Ingelheim today presented new late-breaking data from the EFFISAYIL trial showing that patients receiving the highest dose of spesolimab experienced significantly reduced generalized pustular psoriasis (GPP) flares by 84% over 48 weeks compared to placebo (hazard ratio 0.157; 95% confidence interval 0.05–0.54; p=0.0005). 4 July 2023
With the block on biosimilar versions of AbbVie’s (NYSE: ABBV) mega blockbuster Humira (adalimumab) now removed in the USA, the weekend witnessed the launch of three copycat products in the American market. 3 July 2023
US drug major Bristol Myers Squibb’s Sotyktu (deucravacitinib), a once-daily oral tablet, has been recommended for use on the National Health Service (NHS) in England as an option for treating certain adults with moderate to severe plaque psoriasis. 28 June 2023
The primary endpoint was met in a Phase IIb study (STREAM-AD) of amlitelimab (formerly KY1005) in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. 27 June 2023
US traded shares of Swiss biotech MoonLake Immunotherapeutics leapt almost 79% to $46.58 this morning, after the inflammatory diseases specialist announced positive top-line results from its global Phase II MIRA trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). 26 June 2023
The US Food and Drug Administration (FDA) on Friday approved Litfulo (ritlecitinib), a once-daily oral treatment, for individuals aged 12 years and older with severe alopecia areata. 24 June 2023
German family-owned pharma major Boehringer Ingelheim has revealed that Optum Rx, a leading pharmacy benefit manager and subsidiary of UnitedHealth Group, will place Cyltezo (adalimumab-adbm) on its commercial formulary as a preferred brand, which covers more than 66 million members. 24 June 2023
Privately-held Danish dermatology specialist LEO Pharma has appointed Kreesten Meldgaard Madsen as chief development officer and, effective Tuesday, he joined LEO Pharma’s global leadership team (GLT). 21 June 2023
Spanish dermatology-focused drugmaker Almirall has launched a non pre-emptive share capital increase for a total aggregate amount (including nominal value and share issue premium) of around 200 million euros, by issuing more than 24 million new ordinary shares at 8.20 euros. 14 June 2023
Icelandic firm Alvotech and the US unit of Israel’s Teva Pharmaceutical Industries today revealed they have reached a settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab) in the USA. 12 June 2023
The European Commission (EC) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. 7 June 2023
Belgium’s largest pharma company UCB today revealed that its developmental treatment for adults with hidradenitis suppurativa (HS) has been granted Promising Innovative Medicine (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). 5 June 2023
US biosimilars developer Coherus BioSciences saw its share rise 5% to $4.05 pre-market, after it announced it will launch Yusimry (adalimumab-aqvh) next month. 2 June 2023
Belgium’s largest drugmaker UCB will present new long-term 52-week data from three Phase III studies of bimekizumab at the 2023 meeting of the European Congress of Rheumatology (EULAR). 31 May 2023
Italian-Swiss biotech Philogen has entered into a licensing agreement leading Indian drugmaker Sun Pharmaceuticals for commercializing Philogen’s specialty product, Nidlegy (daromun), in the territories of Europe, Australia and New Zealand. 30 May 2023
Industry analyst GlobalData has highlighted research showing the potential of Janssen’s Tremfya (guselkumab) in the treatment of psoriasis. 30 May 2023
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare. 26 May 2023
Ichthyosis is a heterogenous group of disorders characterized by dry, itchy skin that appears scaly and rough like fish scales.1,2 The first case of ichthyosis was described 24 May 2023
Danish clinical-stage techbio firm Evaxion Biotech, which is developing AI-Immunology powered vaccines, announced new clinical Phase II data for its lead compound EVX-01. 9 September 2024
Danish dermatology specialist LEO Pharma has presented a range of new population-level and physician-reported data on the prevalence, severity and treatment of moderate to severe chronic hand eczema (CHE). 5 September 2024
Biocon Biologics has signed a settlement and license agreement with Johnson & Johnson that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab), in Europe, the UK, Canada, and Japan. 3 September 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
Danish dermatology specialist LEO Pharma’s Timber Pharmaceuticals subsidiary has announced disappointing results for the randomized, double-blind 12-week period of the ASCEND trial. 23 August 2024
San Diego, USA-based biotech AnaptysBio (Nasdaq: ANAB) yesterday announced the pricing of an underwritten offering of 2,750,498 shares of its common stock at a price of $36.50 per share, representing a premium of approximately 10% to Anaptys’ closing price on August 13, 2024. 15 August 2024
Shares of American dermatology company Verrica Pharmaceuticals had a roller-coaster start to the day after announcing what it called positive trial results. 14 August 2024
The US Food and Drug Administration (FDA) has approved Galderma’s Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. 14 August 2024
The US subsidiary of South Korea’s Celltrion announced its US Food and Drug Administration (FDA)-approved biosimilar adalimumab-aaty has been added to the Costco member prescription program. 14 August 2024
Crown Laboratories, a privately held skincare company, and Nashville, USA-based Revance Therapeutics have entered into an agreement whereby the companies seek to merge the two complementary organizations. 13 August 2024
BioNTech released positive top-line data from the ongoing Phase II clinical trial in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. 30 July 2024
California’s Arcutis Biotherapeutics, a biopharma developing innovations in immuno-dermatology, has announced the US commercial launch of Zoryve (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age six years. 30 July 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines for approval at its July 2024 meeting. 26 July 2024
“Circle of Goodness,” one of Russia’s largest public funds, specializing on procurements of drugs for children with rare diseases, will begin procurements of the US drug Vyjuvek (beremagen heperpavec), which is designed for patients with epidermolysis bullosa (butterfly syndrome), reports The Pharma Letter’s local correspondent. 25 July 2024