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
Boston, USA-based non-profit The Institute for Clinical and Economic Review (ICER) has released its final report into the cost-effectiveness of a range of atopic dermatitis (AD) therapies. 18 August 2021
The China National Medical Products Administration (NMPA) has further approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in pediatric patients. 17 August 2021
Lebrikizumab led to significant improvements with at least 75% skin clearance in more than half of people with moderate-to-severe atopic dermatitis (AD), as measured by EASI, in ADvocate 1 and ADvocate 2 Phase III clinical trials announced today. 16 August 2021
Belgium’s largest drugmaker UCB recently presented new interim data from BE BRIGHT, an open-label extension (OLE) trial of an interleukin (IL)-17A/F inhibitor bimekizumab for plaque psoriasis (PsO), at the 2021 American Academy of Dermatology (AAD) Summer Meeting. 16 August 2021
US biotech Regeneron Pharmaceuticals today announced financial results for the second quarter of 2021 that significantly beat analysts’ forecasts, sending the firm’s shares up 2.6% to $595.87 in pre-market trading. 5 August 2021
The UK’s National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination recommending UCB’s bimekizumab as an option for adults with severe plaque psoriasis. 3 August 2021
ParaPRO, a specialty pharma company focused on innovative anti-parasitic treatments, has announced the availability of Natroba (spinosad) Topical Suspension, 0.9%, the first product for scabies to be approved by the US Food and Drug Administration (FDA) in more than 30 years. 3 August 2021
Indian pharmaceutical companies are set to gain from the US Food and Drug Administration's changed stance on biosimilar versions of biological medicines. With the US FDA approving a biosimilar interchangeable insulin product for the treatment of diabetes for the first time in the country, the doors appear to have been opened for generic players, with many considering it a shot in the arm, reports The Pharma Letter’s India correspondent. 2 August 2021
Italian specialty pharma company Cassiopea today announced the signing of license and supply agreements with India’s Sun Pharmaceutical Industries for Winlevi (clascoterone cream 1%) in the USA and Canada. 26 July 2021
XOMA Corp has acquired the royalty interest position Swiss biotech Kuros Biosciences holds in Checkmate Pharmaceuticals’ vidutolimod (CMP-001), an advanced-generation Toll-like receptor 9 agonist packaged in a virus-like particle, for $7.0 million upfront plus sales milestones. 16 July 2021
The USA's Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of a host of therapies for atopic dermatitis (AD). 9 July 2021
The US Food and Drug Administration (FDA) has approved an expanded label for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, as monotherapy for the treatment of locally-advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. 6 July 2021
AbbVie saw its share close down 1.5% at $112.98 on Friday, after it revealed that the US Food and Drug Administration has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis. 28 June 2021
At its June meeting, the European Medicines Agency’s human medicines committee (CHMP) recommended six novel medicines for approval, and issued a negative opinion on one. 26 June 2021
The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) to treat locally advanced or metastatic basal cell carcinoma (BCC) patients who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). 25 June 2021