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
The US medicines regulator has issued a warning letter to Indian contract development and manufacturing organization (CDMO) Brassica Pharma for severe data integrity violations at its manufacturing facility in Thane. 24 July 2024
In San Francisco, RAPT Therapeutics (Nasdaq: RAPT) has announced a substantial workforce reduction as part of its cash conservation strategy. 23 July 2024
STADA Arzneimittel and Iceland-based Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara (ustekinumab) in Europe, across a majority of European countries. 22 July 2024
Privately-held German drugmaker Boehringer Ingelheim has inked a deal with GoodRx (Nasdaq: GDRX), in a bid to boost US penetration of its biosimilar to Humira (adalimumab). 18 July 2024
The show is over for Aslan Pharmaceuticals, the immunology-focused biopharmaceutical company, as its financial troubles have led it to file for voluntary liquidation. 18 July 2024
AbbVie’s market leadership, driven by its flagship disease-modifying antirheumatic drug Humira (adalimumab), faced a significant test with the 2023 loss of patent protection. 16 July 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Ebglyss (lebrikizumab) for use in moderate to severe atopic dermatitis in the National Health Service (NHS) in England. 10 July 2024
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe) submitted by South Korean firm Samsung Bioepis. 1 July 2024
US immuno-dermatology specialist biotech Dermavant Sciences, a subsidiary of Roivant Sciences, has achieved positive Phase III trial results with Vtama (tapinarof), a nonsteroidal, topical AhR-modulating agent, in atopic dermatitis (AD). 14 June 2024
Belgium’s UCB is sharing results from three studies supporting the value of Cimzia (certolizumab pegol) for women of childbearing age living with chronic immune-mediated diseases and people with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels. 13 June 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 10 June 2024
The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall, to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm. 10 June 2024
Shares of Replimune closed up nearly 28% at $7.11 on Thursday after the company shared data on its oncolytic virus RP1 (vusolimogene oderparepvec), in combination with Bristol Myers Squibb’s Opdivo (nivolumab), 7 June 2024
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024