Today, the US Centers for Medicare & Medicaid Services (CMS) has for the first time selected 10 drugs for negotiation. Seniors paid $3.4 billion in out-of-pocket costs for these drugs in 2022, the CMS stated. 29 August 2023
Japanese mid-size drugmaker Kyowa Kirin says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for partial change of approved indication of Lumicef (brodalumab [genetical recombination]) for the treatment of palmoplantar pustulosis (PPP) that respond inadequately to existing therapies. 24 August 2023
US rare and orphan dermatologic diseases firm Timber Pharmaceuticals saw it shares almost double to $2.79 this morning, on the news of a takeover bid. 21 August 2023
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Danish dermatology specialist LEO Pharma’s delgocitinib cream. 18 August 2023
Positive data for a new kind of medicine, a BTK inhibitor developed by Novartis, could pave the way to improved treatment options for people with chronic spontaneous urticaria. 9 August 2023
German companies Fresenius Kabi and Formycon have reached a settlement with US healthcare giant Johnson & Johnson for the USA, concerning FYB202, a proposed biosimilar to Stelara (ustekinumab). 8 August 2023
Nektar Therapeutics’ shares closed up a massive 82.6% at $0.98 yesterday, after it revealed announced that efficacy data previously generated by former partner Eli Lilly for Rezpeg (rezpegaldesleukin) that were presented at the September 2022 EADV Congress were incorrectly calculated by Lilly. 8 August 2023
South Korea’s Samsung Bioepis and USA-based Organon have announced the interchangeable result of its Humira (adalimumab) biosimilar, SB5, based on a recently conducted Phase IV study. 3 August 2023
US dermatology specialist Verrica Pharmaceuticals announced the closing of the previously announced $125 million debt financing with OrbiMed, a leading healthcare investment firm. 27 July 2023
The US Food and Drug Administration (FDA) has approved Ycanth (cantharidin), a drug/device for the topical treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. 25 July 2023
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 novel medicines, as well as some biosimilars and indication extensions, for approval at its July 2023 meeting. 21 July 2023
Privately-held Recludix Pharma has agreed a deal with French pharma major Sanofi to develop and commercialize oral small molecule STAT6 (signal transducer and activator of transcription 6) inhibitors for immunological and inflammatory (I&I) diseases. 21 July 2023
The European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), submitted by Belgium’s largest pharma company UCB. 18 July 2023
Dermatology specialist Journey Medical has announced positive top-line results from two Phase III trials of its rosacea candidate, DFD-29, a formulation of minocycline hydrochloride. 11 July 2023
Danish pharma and medical equipment maker Coloplast on Friday revealed it has entered into an agreement to acquire Kerecis, an Iceland based developer of biologics for the wound care market, using. fish skin to develop tissue-transplant products. 8 July 2023
Spanish skincare specialist Almirall has announced positive results from a real-world study of Ilumetri (tildrakizumab) at the 25th World Congress of Dermatology. 7 July 2023
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 5 July 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