VDA Net srl
Banca Dati Sanitaria Farmaceutica dal 1996
Le Aziende Farmaceutiche Informano
16 Giugno 2025
Il servizio prevede la segnalazione giornaliera dei comunicati che le Aziende Farmaceutiche pubblicano sui loro siti aziendali
|
|
Le Aziende Farmaceutiche
Informano
Fonte: Abbisko Therapeutics
Abbisko Therapeutics Completes First
Patient Dosing in Registrational Study of Irpagratinib for
HCC - Abbisko Therapeutics (HKEX Code: 02256) today announced that it has
completed first patient dosing in a registrational study of irpagratinib, a
self-developed and highly-selective small molecule FGFR4 inhibitor, for the
treatment of Hepatocellular Carcinoma (HCC).
Fonte: Ark Biopharmaceutical
ArkBio's New Drug Application for ADHD
Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA - Shanghai Ark Biopharmaceutical Co., Ltd.
("ArkBio") today announced that the National Medical Products
Administration (NMPA) has officially accepted its New Drug Application (NDA)
for Azstarys
(serdexmethylphenidate/dexmethylphenidate extended-release capsules)
and granted it Priority Review designation. The investigational therapeutic
drug is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder
(ADHD) in patients aged six years and above.
Fonte:
Ascentage
EHA 2025 | Multiple Studies Report
Encouraging Data of Olverembatinib
in Ph+ ALL - Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global
biopharmaceutical company dedicated to addressing unmet medical needs in
cancers, announced that results from 13 studies of its core assets, including
the novel drug olverembatinib (HQP1351)
and the investigational EED inhibitor APG-5918, have been reported at the 2025
European Hematology Association (EHA) Annual Congress
Fonte: Genmab
Genmab Announces Investigational Rinatabart
Sesutecan (Rina-S) Demonstrates Encouraging Anti-Tumor Activity in
Heavily Pretreated Patients with Advanced Endometrial Cancer in Phase 1/2
RAINFOL-01 Trial - New data showed that rinatabart sesutecan (Rina-S) 100 mg/m2
led to a confirmed objective response rate (ORR) of 50.0 percent, including two
complete responses (CR), and median duration of response (mDOR) was not reached
after a median follow-up of 7.7 months - Continued evaluation of single-agent
Rina-S 100 mg/m2 in patients with advanced endometrial cancer (EC) is ongoing
in the Phase 2 RAINFOL-01 trial and will be further evaluated in a planned
Phase 3 trial
Fonte: Genmab
Genmab Announces Epcoritamab
Investigational Combination Therapy Demonstrates High Response Rates in
Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma
(DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT) - Results from
the EPCORE NHL-2 trial show investigational treatment with epcoritamab in
combination with rituximab,
ifosfamide,
carboplatin,
and etoposide
(R-ICE) led to an overall response rate (ORR) of 87 percent and a complete
response (CR) rate of 65 percent in patients with relapsed or refractory (R/R)
diffuse large B-cell lymphoma (DLBCL) - Data further demonstrates the potential
of epcoritamab in combination with salvage chemoimmunotherapy to increase the
proportion of patients to qualify for Autologous Stem Cell Transplantation
(ASCT) - Data was presented during an oral session at the 30th European
Hematology Association (EHA) Congress
Fonte:
Incyte
Positive Late-Breaking Data for
Incyte’s First-in-Class mutCALR-targeted therapy
INCA033989 in Essential Thrombocythemia Presented at EHA2025 - Data
demonstrates the potential for INCA033989 to modify disease by directly
inhibiting and eliminating oncogenic mutCALR cells, while sparing healthy cells
and restoring normal blood cell production - In high-risk patients with
essential thrombocythemia (ET) with a CALR mutation (mutCALR), 86% of
INCA033989-treated patients at doses 400 mg and above achieved a complete or
partial hematologic response with the majority (82%) realizing a complete
response - A reduction in peripheral blood mutCALR variant allele frequency
(VAF) was observed in 89% of evaluable patients correlating with hematologic
response - Initial results demonstrate a favorable safety profile – no dose
limiting toxicities were reported, a maximum tolerated dose was not reached and
98% of patients remained on treatment - Incyte will host an in-person analyst and
investor event highlighting this data at EHA today, Sunday, June 15, 2025, from
6:00 - 7:30 a.m. EDT (12:00 -1:30 p.m. CEST)
Fonte: Innovent
Innovent Announces Completion of
First Participant Dosed in the Seventh Phase 3 Clinical Trial (GLORY-OSA) of Mazdutide
in China
Fonte: Johnson
& Johnson
Investigational combination of first-in-class
bispecifics TALVEY
and TECVAYLI
shows deep and durable responses in heavily pretreated multiple myeloma
patients with extramedullary disease - Results from the Phase 2 RedirecTT-1
study demonstrate deep responses with 78.9 percent overall response rate
through dual targeting of GPRC5D and BCMA - Data signal potential of novel,
off-the-shelf approach in patients with extramedullary disease who face
significant unmet needs
Fonte: Keymed
Biosciences
Keymed Biosciences Announces the
Latest Clinical Trial Results of CM336
Published in the New England Journal of Medicine
Fonte: Qiagen
QIAGEN and Incyte Announce Precision
Medicine Collaboration to Develop Companion Diagnostics for Patients With
Mutant CALR-expressing Myeloproliferative Neoplasms (MPNs) - QIAGEN to create a
multimodal panel using next-generation sequencing (NGS) technology for
detecting clinically relevant gene alterations in hematological malignancies -
Companion diagnostic to identify key disease-causing mutations in patients with
MPNs, with an initial focus on mutant CALR the second most common driver of
MPNs - Panel to be validated on Illumina NextSeq 550Dx platform for use with
whole blood samples - Partnership supports Incyte’s extensive portfolio in
myeloproliferative neoplasms, including
INCA033989, and enhances QIAGEN’s onco-hematology diagnostics pipeline
Fonte: Samsung
Biologics
Samsung Biologics launches drug
screening services, Samsung Organoids
- Samsung Organoids to provide data-driven analysis of candidate molecules -
Samsung Biologics expands service scope to include preclinical research
Fonte: Sanofi
EAACI: Dupixent
demonstrated superiority over Xolair
(omalizumab) in chronic rhinosinusitis with nasal polyps in patients
with coexisting asthma in first-ever presented phase 4 head-to-head respiratory
study - New late-breaking data at EAACI showed Dupixent outperformed Xolair
across all primary and secondary efficacy endpoints of CRSwNP and in all
asthma-related endpoints - Dupixent also outperformed Xolair in improving such
key signs and symptoms as nasal polyp size and sense of smell in CRSwNP, and
lung function and disease control in asthma, with rapid improvements seen as
early as 4 weeks - Results reinforce the efficacy of Dupixent in treating both
upper and lower respiratory diseases by targeting IL-4 and IL-13, two key
drivers of type 2 inflammation
Fonte: Sarepta
Therapeutics
Sarepta Provides Safety Update for ELEVIDYS
and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with
Duchenne - The Company is developing an enhanced immunosuppressive regimen in
consultation with a panel of multi-disciplinary clinical experts and engaging
with regulators - Shipments of ELEVIDYS for infusions in non-ambulatory
patients in commercial setting are suspended until enhanced regimen is approved
and in place - ENVISION study is paused while seeking a protocol amendment to
incorporate additional immunosuppression - Sarepta to host investor call on
June 16, 2025, at 8:00 am Eastern time
|
|
© VDA Net srl Unipersonale - Viale Cortina d'Ampezzo, 186 - 00135 Roma (Italia)
Partita IVA: 09575411005 - Registro Impresa: 179563/2007 - REA: 1173331
Telefono: +39 3336729237 - Contatti
Responsabile della protezione dei dati (GDPR): Antonello Viti De Angelis
Informativa privacy e Profilo utente: Accedi
Disclaimer - Cookie Declaration
Richiesta di aggiunta e/o modifica indirizzi di posta elettronica: Modulo
Riproduzione
riservata agli abbonati per un uso personale o aziendale.
Qualsiasi altro
diverso utilizzo, anche parziale dei nostri servizi, deve essere preventivamente concordato
per iscritto con la VDA Net srl.
Tutte le informazioni presenti in questo documento non sostituiscono in
alcun modo il giudizio di un medico specialista, l'unico autorizzato ad
effettuare una consulenza e ad esprimere un parere medico
|
|
|