The atopic dermatitis (AD) market is on track to reach $16.7 billion across mature markets by 2030, according to data and analytics company GlobalData. 19 September 2024
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
Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of its Cosentyx (secukinumab). 21 November 2014
The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major Sanofi and Regeneron’s dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. 20 November 2014
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Swiss pharma giant Novartis to provide more information on its Xolair (omalizumab), a drug to treat chronic hives. 19 November 2014
Anglo-Swedish drug major AstraZeneca and USA-based Amgen, the world’s largest independent biotech firm, say that a Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, when compared with Stelara (ustekinumab) and placebo at week 12, has met its primary endpoint. 12 November 2014
Independent Danish dermatology specialist Leo Pharma has demonstrated significant improvement in psoriasis disease severity in trials of its Daivobet gel (calcipotriol and betamethasone). 29 October 2014
The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration yesterday voted unanimously to support the approval of Swiss pharma major Novartis’ secukinumab (AIN457), a selective interleukin-17A (IL-17A) inhibitor. 21 October 2014
US biotech company Celgene took a practical approach to raising awareness of psoriasis and psoriatic arthritis (PA) during the annual meeting of the European Academy of Dermatology and Venereology (EADV) in Amsterdam, the Netherlands, last week. 14 October 2014
Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients aged 12 to 17 years old. 13 October 2014
US pharma company AbbVie has reported new data with its mega blockbuster arthritis drug Humira (adalimumab) that could lead to another indication for the product. 13 October 2014
Swiss drug major Novartis has reported data from a Phase III trial showing consistent efficacy in clearing psoriasis with AIN457 (secukinumab), regardless of how bad patients’ disease is at the start of treatment. 10 October 2014
US biotech major Amgen says its Phase III study evaluating the efficacy and safety of its biosimilar candidate ABP 501 compared with AbbVie’s blockbuster drug Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint. 9 October 2014
US biopharma company Coronado Biosciences has formed a wholly-owned subsidiary, Journey Medical Corporation (JMC), to acquire and license dermatology products. 8 October 2014
USA-based specialty pharmaceutical company Zynerba Pharmaceuticals, focused on innovative transdermal cannabinoid treatments, has named two leading industry veterans to lead the company. 2 October 2014
Swiss drug major Novartis' AIN457 (secukinumab) has met the primary and key secondary endpoints in two pivotal Phase III studies of in psoriatic arthritis. 25 September 2014
The US Food and Drug Administration has approved biotech major Celgene’s Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. 24 September 2014
US pharma giant Merck & Co has entered into an exclusive worldwide licensing agreement with Indian drugmaker Sun Pharmaceuticals for Merck’s investigational therapeutic antibody candidate, tildrakizumab, (MK-3222). 17 September 2014
US pharma group AbbVie has released results from a Phase III pivotal study demonstrating that its blockbuster arthritis drug Humira (adalimumab) is effective in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules. 11 September 2014
New data from the international FIELD Study Repeat presented today at the 15th World Congress of Cancers of the Skin (WCCS) in Edinburgh, Scotland, demonstrate initial treatment with Picato(ingenol mebutate gel) 0.015% is efficacious in treating actinic keratoses (AK) and, when followed by a repeat cycle for persistent and newly emerging AKs, this efficacy is further increased. 4 September 2014
Perrigo has said it has filed an Abbreviated New Drug Application for desoximetasone topical spray 0.25%, currently marketed as Topicort by Taro. 30 July 2014
The USA’s Retrophin has submitted an unsolicited $95 million takeover proposal to the board of directors of Australian biotech firm Clinuvel Pharmaceuticals, the shares of which rocketed 28% to A$2.15 in mid-morning trading today. 28 July 2014