At the European Academy of Dermatology and Venerology (EADV) congress in Berlin, AbbVie is presenting positive results from the Phase IIb NCT04927975 study. 12 October 2023
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Icelandic firm Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Johnson & Johnson Stelara (ustekinumab). 12 October 2023
San Diego, USA-based biotech AnaptysBio saw its shares edge up 3.6% to $19.95, after it released results from the Phase III GEMINI-1 trial evaluating the safety and efficacy of imsidolimab (interleukin (IL)-36R MAb) in patients with generalized pustular psoriasis (GPP) flares. 10 October 2023
Privately-held Danish dermatology specialist LEO Pharma has named Professor Alexander Egeberg, a globally recognized dermatologist and top key opinion leader as the company’s new vice president, head of global medical affairs. 9 October 2023
Leading Indian drugmaker Sun Pharmaceutical Industries today revealed that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. 6 October 2023
US immuno-dermatology specialist biotech Dermavant Sciences, a subsidiary of Roivant Sciences, has appointed John Darden as vice president of marketing. 6 October 2023
Privately-held Swiss dermatology company Galderma has announced some bad news relating to its pending Biologics License Application (BLA) for relabotulinumtoxinA (QM-1114) to the US Food and Drug Administration (FDA). 3 October 2023
The US Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema), the drug’s developer, US pharma major Eli Lilly, announced yesterday. 3 October 2023
Australian dermatology company Botanix today revealed it has received a communication from the US Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) submission for sofpironium bromide (SB) gel, 15%. 26 September 2023
Privately-held Danish company MC2 Therapeutics has acquired option rights from US dermatology firm Regranion to exclusively license the latter’s RGRN-305 for the treatment of all human diseases. 25 September 2023
Belgian drugmaker UCB is not expecting a decision from the US Food and Drug Administration (FDA) any time soon on its Biologics License Application (BLA) for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis. 20 September 2023
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Adtralza (tralokinumab) in a new pre-filled pen, developed by privately-held Danish dermatology specialist LEO Pharma. 20 September 2023
The European Commission (EC) has become the third medicines regulator to grant marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. 19 September 2023
Citing resource constraints for the decision, the US Food and Drug Administration (FDA) says requires additional time to complete the Priority Review of Iovance Biotherapies’ Biologics License Application (BLA) for lifileucel. 18 September 2023
Following its September 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of six novel medicines. 15 September 2023
Samsung Bioepis has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Johnson & Johnson subsidiary Janssen’s Stelara (ustekinumab). 11 September 2023
Industry analyst GlobalData has released research suggesting that a new Humira (adalimumab) biosimilar can expect to reach over $800 million in sales by the end of the decade. 1 September 2023
Privately-held Danish company MC2 Therapeutics today announced an agreement under which a Huadong Medicine unit has been granted exclusive rights in Greater China to develop and commercialize MC2’s drug, Wynzora Cream for the treatment of plaque psoriasis. 31 August 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