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Banca Dati Sanitaria Farmaceutica dal 1996
Le Aziende Farmaceutiche Informano
  03 Dicembre 2025
 

Esempio di una circolare giornaliera

Le Aziende Farmaceutiche Informano
 
AbbVie
AbbVie to Feature New Data at ASH 2025 Showcasing Continued Advances Across Novel Treatment Modalities in Multiple Blood Cancers - Data being presented showcases AbbVie's breadth and depth of research across a range of therapeutic modalities such as T-Cell Engagers, BCL-2 Inhibitors and Antibody-Drug Conjugates for a spectrum of difficult-to-treat blood cancers - AbbVie (NYSE: ABBV) today announced it will unveil new data at the 2025 American Society of Hematology (ASH) Congress, showcasing continued advances in research across multiple blood cancers including — multiple myeloma (MM), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and amyloidosis (AL). Data across AbbVie's blood cancer portfolio will be featured in multiple oral and poster presentations including investigational compounds etentamig (ABBV-383) and PVEK (pivekimab sunirine), as well as approved therapies EPKINLY (epcoritamab-bysp) and VENCLEXTA (venetoclax).
 
AGC Biologics
AGC Biologics Partners with ATUM to Accelerate Timelines for Cell Line Development - New offering provides drug developers with flexible and powerful cell line development options for monoclonal antibodies, multi-specific and complex molecules  - As drug developers face increasing pressure to lower prices and accelerate time to market, global biopharmaceutical contract development and manufacturing organization AGC Biologics is expanding its Cell Line Development Center of Excellence by partnering with ATUM to integrate the Leap-In Transposase expression platform within its offerings. This partnership provides drug developers with technology designed to increase yields and significantly shorten the path to clinical trials, directly addressing the market’s need for speed and efficiency.
 
Amgen
Bio Meets Tech: How Amgen is Designing the Medicines of Tomorrow - Amgen is using artificial intelligence (AI) to help design new proteins with therapeutic properties considered from the start, accelerating discovery of next-generation medicines. - The company's AMPLIFY protein language model, co-developed with Mila, teaches AI the language of proteins to make protein engineering faster, smarter and more accessible. - By combining AI, automation and biology, Amgen has leveraged its generative biology platform to triple protein engineering speed and cut discovery timelines in half.
 
AstraZeneca
Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension - Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension - If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorisation
 
Atossa Therapeutics
Insilico Medicine and Atossa Therapeutics Publish AI-Driven Study in Nature Scientific Reports Identifying (Z)-Endoxifen as a Potential Therapeutic Candidate for Glioblastoma - Insilico Medicine ("Insilico"), a global leader in AI-powered drug discovery, and Atossa Therapeutics ("Atossa") (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel treatments for breast cancer and other serious conditions, announce the publication of a joint study evaluating the potential of (Z)-endoxifen for glioblastoma multiforme (GBM). The peer-reviewed article, now published in Nature's Scientific Reports, represents one of the most comprehensive AI-enabled analyses to date exploring whether endoxifen, an active metabolite of tamoxifen with known activity in endocrine-resistant breast cancer, may offer new therapeutic opportunities for one of the deadliest malignant brain tumors in adults. The study aimed to identify new oncology indications with high therapeutic potential for endoxifen, as monotherapy or in combination, by applying Insilico's AI-powered PandaOmics platform across a wide range of cancer types based on its mechanisms of action. Through this systematic evaluation, GBM emerged as a top candidate for further investigation.
 
Bayer
Bayer starts Phase III study with long-acting reversible intrauterine system for treatment of nonatypical endometrial hyperplasia - Expansion of robust clinical development program of Bayer’s long-acting reversible intrauterine system Mirena (52mg LNG-IUS) / Nonatypical endometrial hyperplasia (NAEH) is benign form of endometrium thickening / Number of new cases annually ranges from 121 to 270 per 100.000 women depending on the population.1,2,3 Currently, there are no approved medical treatment options for NAEH / 52mg LNG-IUS is globally available and in more than 120 countries approved in several indications: prevention of pregnancy, heavy menstrual bleeding, endometrial protection during estrogen therapy for menopausal symptoms and for menstrual pain / Reinforcing Bayer’s leading position and commitment to understanding and advancing women’s healthcare in areas of unmet medical need
 
Celltrion
Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR - FDA approval of OMLYCLO (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases - OMLYCLO (omalizumab-igec) is the first and only biosimilar designated as interchangeable with XOLAIR (omalizumab); The FDA previously approved OMLYCLO 75 mg/0.5 mL and 150 mg/mL in a single-dose prefilled syringe for subcutaneous injection in March 2025
 
Eisai
New Data Presented at CTAD 2025 Confirms Pharmacological Effect of LEQEMBI (lecanemab-irmb) on Neurotoxic Aβ Protofibrils in CS - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name LEQEMBI), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF) was presented at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference. The findings represent the results from a large-scale clinical study demonstrating, for the first time, that binding of lecanemab to PF can be measured in CSF, enabling further understanding of how lecanemab slows Alzheimer’s disease (AD) progression.
 
Ionis Pharmaceuticals
Ionis receives U.S. FDA Breakthrough Therapy designation for zilganersen for Alexander disease (AxD) - First and only investigational medicine for this rare, often fatal neurological condition – On track to submit new drug application (NDA) in Q1 2026
 
Jazz Pharmaceuticals
Jazz Pharmaceuticals to Present Pivotal Phase 3 Results of Ziihera (zanidatamab-hrii) Combinations in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma at the 2026 ASCO Gastrointestinal Cancers Symposium - Late-breaking HERIZON-GEA-01 presentation highlights the expanding clinical profile of Ziihera across HER2-driven gastrointestinal cancers - Jazz to host investor webcast on Friday, January 9, 2026, to review data
 
Lundbeck
Lundbeck to present comprehensive new bexicaserin dataset in patients with rare childhood-onset epilepsies, at American Epilepsy Society (AES) Annual Meeting - New data to be presented at the 2025 AES Annual Meeting indicate sustained reductions in seizure frequency as early as two weeks after treatment initiation with bexicaserin - Bexicaserin is an investigational compound in development for the treatment of seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs) - DEEs are a group of severe childhood-onset epilepsies with the majority of DEEs resistant to conventional anti-seizure medications . Eight presentations at AES highlight Lundbeck’s dedication to improving outcomes for people with rare epilepsies
 
Otsuka Pharmaceutical
Otsuka Launches Frailty Prevention Support VR as Newest Content in FACEDUO VR Program Portfolio - Enables earlier detection of frailty to support health maintenance and prevent or defer the need for nursing care - Otsuka Pharmaceutical Co., Ltd. (Otsuka) has started to offer new content Frailty Prevention Support VR within the VR (virtual reality) training program FACEDUO, in collaboration with Jolly Good Inc. This new content aims to raise awareness of early signs of frailty through VR-simulated experiences, supporting health maintenance and prevention or deferment of nursing care.
 
Otsuka Pharmaceutical
Otsuka Receives FDA Accelerated Approval for VOYXACT (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression - VOYXACT achieved a significant placebo-adjusted treatment effect of 51% (P<0.0001) reduction in proteinuria at 9 months of treatment (50% VOYXACT vs 2% placebo) in the VISIONARY Phase 3 interim analysis. - In the study, the most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) reported in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%). - VOYXACT blocks A-PRoliferation-Inducing-Ligand (APRIL), resulting in reduced levels of serum galactose-deficient IgA1 (Gd-IgA1). Gd-IgA1 is implicated in the pathogenesis of IgAN. - Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as a surrogate endpoint in IgAN clinical trials to support accelerated regulatory approvals. - VOYXACT is a self-administered, subcutaneous injection dosed every 4 weeks. - Despite the current standard of care, IgAN is a progressive, immune-mediated, chronic kidney disease that typically manifests in adults aged 20-40 years and can lead to end-stage kidney disease (ESKD) over the lifetime of most patients.
 
Samsung Bioepis
Pre-filled Syringe Presentation of BYOOVIZ, Samsung Bioepis’ Biosimilar to Lucentis (Ranibizumab), Gains European Approval - European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for BYOOVIZ (ranibizumab) pre-filled syringe (PFS) - PFS presentation to become available in Europe in the second quarter of 2026, after the full transition of commercial rights from Biogen back to Samsung Bioepis in January 2026 - Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ pre-filled syringe (PFS), a biosimilar referencing Lucentis (ranibizumab). BYOOVIZ was first approved by the European Commission (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV)
 
Sangamo Therapeutics
Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber Neuropathy - Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain. - Fast Track Designation aims to facilitate the development and expedite the review of new therapeutics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Companies granted this designation are given the opportunity for more frequent interactions with the FDA. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
 
Zentiva
Zentiva Expands into Biologics with the EU-Wide Launch of Its First Biosimilar - Launch marks Zentiva’s strategic entry into biosimilars and reinforces its mission to broaden patient access to high-quality biologic medicines across Europe. - Zentiva, a leading European manufacturer of affordable, high-quality medicines, today announced the first EU-wide launch of a monoclonal antibody biosimilar, following approval by the European Medicines Agency (EMA). This milestone marks Zentiva’s entry into the biosimilar segment, further strengthening its position as a trusted healthcare partner dedicated to improving patient access to essential treatment
 

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