Novità
Sanitarie Farmaceutiche
MHRA Medicines and Healthcare products
Regulatory Agency
MHRA
approves tisotumab vedotin for the treatment of cervical cancer
As with all licensed
medicines, we will continue to monitor its safety closely as it becomes more
widely used - The Medicines and
Healthcare products Regulatory Agency (MHRA) has today, 2 December 2025,
approved tisotumab
vedotin (Tivdak) used for the treatment of adults with cervical cancer
that has come back or spread. It is used if the disease worsened after previous
anti-cancer treatment. - Tisotumab vedotin is administered via an intravenous
infusion (drip) into the vein over 30 minutes once every three weeks.
Esot The European Society of Organ
Transplantations
New
position paper outlines management of vascular access after kidney
transplantation
A new position paper published in
Transplant International provides much-needed guidance on how to manage
vascular access (VA) following kidney transplantation (KT): an area where
clinical practice has varied widely. - Produced jointly by the Vascular Access
Society (VAS) and the European Kidney Transplant Association (EKITA-ESOT), the
expert statement reviews current evidence on the haemodynamic impact of
arteriovenous fistulas (AVFs) and highlights how high-flow accesses may
contribute to cardiovascular strain in transplant recipients. - The authors
propose a practical algorithm for post-transplant VA surveillance, recommending
routine Doppler assessment, cardiac evaluation where flows are elevated, and
multidisciplinary decision-making. They note that elective AVF ligation may be
appropriate for some stable recipients with high-flow access, while emphasising
the importance of individualised care and patient involvement. - The paper also
calls for further prospective studies to understand long-term outcomes and to
refine guidance. As transplant survival continues to improve, the authors argue
that proactive VA management will be increasingly important for protecting
long-term cardiovascular health.
FDA Food and Drug Administration
FDA
Releases Draft Guidance on Reducing Testing on Non-Human Primates for
Monoclonal Antibodies
Today, the U.S. Food and
Drug Administration (FDA) issued draft guidance outlining specific product
types for which the FDA believes six-month non-human primate toxicity testing
can be eliminated or reduced. - The guidance reflects the FDA’s continued
progress in modernizing nonclinical drug evaluation to make it more efficient
and to reduce animal testing. In lieu of animal testing, the FDA is
incorporating risk assessments that integrate human-relevant models - including computational toxicology, organoid
systems, and real-world human safety data - into regulatory decision-making
NICE National Institute for Health and
Care Excellence
Talquetamab for treating
relapsed and refractory multiple myeloma after 3 or more treatments
Evidence-based
recommendations on talquetamab (Talvey) for treating
relapsed and refractory multiple myeloma after 3 or more treatments in adults.
- Last reviewed: 03 December 2025 -
Next review: This guidance will be reviewed if there is new evidence that is
likely to change the recommendations
NICE National Institute for Health and
Care Excellence
Glofitamab with gemcitabine
and oxaliplatin for treating relapsed or refractory diffuse large B-cell
lymphoma
Evidence-based
recommendations on glofitamab (Columvi)
plus gemcitabine and oxaliplatin for treating relapsed or refractory diffuse
large B‑cell lymphoma not otherwise specified in adults. - Last reviewed: 03 December 2025 - Next
review: This guidance will be reviewed if there is new evidence that is likely
to change the recommendations
NICE National Institute for Health and
Care Excellence
Child maltreatment: when to
suspect maltreatment in under 18s
This guideline covers the
signs of possible child maltreatment in children and young people aged under 18
years. It aims to raise awareness and help health professionals who are not
child protection specialists to identify the features of physical, sexual and
emotional abuse, neglect and fabricated or induced illness.
Last reviewed: 3 December 2025 - We added a definition
of independently mobile in the context of recommendations 1.1.2, 1.1.5 and
1.1.6. - Next review: This guidance will be reviewed if there is new evidence
that is likely to change the recommendations.
PMDA (Pharmaceuticals and Medical Device
Agency) (Giappone)
Quality of Fecal
Microbiota Transplantation (FMT) Products at the Initial Development Stage (Early
Consideration)
October 31, 2025 Office
of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices
Agency
NHS National Health Service (Agenzia
Governativa Inglese)
Life-changing
AI support helping stroke patients get a second chance
Stroke patients in
England are getting life-changing treatment more than an hour earlier thanks to
a revolutionary “fast-track” AI tool, a major study has revealed. - The
landmark analysis published inThe Lancet Digital Health shows around 15,000
patients directly benefitted from having their scans reviewed by the tech. -
The AI tool - now rolled out by the NHS to a network of over 70 hospitals -
helps doctors spot deadly clots in minutes, speeding up clinical decision
making and helping get patients rushed to specialist stroke centres faster. -
It means patients are more likely to be able to get a thrombectomy - a
minimally invasive clot-removing procedure - faster, doubling their chances of
regaining independence after a major stroke.
EFPIA European Federation of
Pharmaceutical Industries and Associations
EFPIA
response to the Council General Approach on the Critical Medicines Act
EFPIA welcomes today’s
adoption of the Council’s General Approach on the Critical Medicines Act (CMA).
- EFPIA welcomes today’s adoption of the Council’s General Approach on the
Critical Medicines Act (CMA). This is an important step toward strengthening
the availability, accessibility and security of supply of medicines for
patients across Europe. - We support the Council’s efforts to keep the CMA
focused on genuinely critical medicines where targeted action can make a
meaningful difference. To be effective, the Act must remain proportionate and
avoid broad mechanisms that risk stretching resources and blurring the line
between supply issues and wider medicines access challenges. In this context,
EFPIA continues to seek a more precise definition of medicinal products of
common interest, limited to cases of clear market failure.
FDA Food and Drug Administration
FDA
Seizes 7-OH Opioids to Protect American Consumers
The U.S. Food and Drug
Administration, in coordination with the U.S. Department of Justice, announced
today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine
(7-OH) products - valued at roughly $1 million - from three firms in
Missouri. - The seizure focused on foods and dietary supplement products -
including liquid shots and tablets - containing concentrated 7-OH as an added
ingredient. Concentrated 7-OH is increasingly recognized as having potential
for abuse because of its ability to bind to opioid receptors. It cannot be
lawfully added to dietary supplements or conventional foods. These products are
considered adulterated because 7-OH does not meet applicable safety standards.
Also, the FDA has not approved 7-OH for medical use.
EMA Agenzia Europea per I Medicinali
Paediatric Investigation Plan (Aggiornamento del
02 dicembre 2025)
Un piano di indagine pediatrica (PIP) è un piano di sviluppo
volto a garantire che i dati necessari siano ottenuti tramite studi sui
bambini, per supportare l'autorizzazione di un medicinale per bambini. Tutte le
domande di autorizzazione all'immissione in commercio per nuovi medicinali
devono includere i risultati degli studi come descritto in un PIP concordato, a
meno che il medicinale non sia esente a causa di un differimento o di una
deroga.
ravulizumab
- Treatment of primary immunoglobulin A nephropathy
spesolimab - Treatment of Netherton syndrome
Commissione
Europea
Selezione
delle novita’ sui medicinali uso umano pubblicate sul sito web della CE
Nuove Autorizzazioni -
Modifiche e Comunicazioni pubblicate sui seguenti medicinali:
Imaavy (nipocalimab) – Centralised Authorisation
Imaavy is indicated as
an add-on to standard therapy for the treatment of generalised Myasthenia
Gravis (gMG) in adult and adolescent patients aged 12 years of age and older
who are anti acetylcholine receptor (AChR) or anti-muscle-specific tyrosine
kinase (MuSK) antibody positive.
Eurartesim
(piperaquine tetraphosphate/artenimol)
Posaconazole
(Accord)
Sunitinib
(Accord)
Teriflunomide
(Accord)
EMA
Agenzia Europea per i Medicinali
Selezione delle novita’
sui medicinali uso umano pubblicate sul sito web dell'EMA
Nuove
Autorizzazioni - Modifiche e Comunicazioni pubblicate sui seguenti medicinali:
Aluvia (lopinavir – ritonavir) - opinion on medicine
for use outside EU
Gilenya (fingolimod)
Izamby (denosumab)
Kaletra (lopinavir – ritonavir)
Krazati
(adagrasib)
Pregabalin
(Sandoz)
Tevimbra
(tislelizumab)
Upstaza
(eladocagene exuparvovec)
FDA
Food and Drug Administration
Pubblicazioni delle nuove autorizzazioni
all’immissione in commercio (Orig-1) dei seguenti farmaci:
BRIVARACETAM
(MSN LABORATORIES PRIVATE LTD) - (Tentative Approval)
CDA-AMC
Canada’s Drug Agency - L’Agence des Medicaments du Canada - Novita’ sui Farmaci
(N/A)
significa non disponibile (il nome del prodotto non è disponibile)
(TBC)
significa da confermare (il nome del prodotto deve ancora essere confermato)
(TBD)
Il nome del prodotto deve essere determinato
delgocitinib
(Anzupgo)
fecal
microbiota (Rebyota)
upadacitinib
(Rinvoq)
epinephrine
(Neffy)
isatuximab
(Sarclisa)
AIFA
Agenzia Italiana del Farmaco
Notifica
dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali
Modalità di notifica dei documenti prodotti
dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato
cartaceo e prodotti in formato elettronico e firmati digitalmente).
AIFA
Agenzia Italiana del Farmaco
Farmaci
Carenti (Aggiornati al 02
dicembre 2025)
Per farmaco "carente” si intende un medicinale
temporaneamente non reperibile sul territorio nazionale in quanto il titolare
AIC (il responsabile legale dell'autorizzazione e della commercializzazione del
medicinale) non può assicurarne una fornitura continua, rispetto al bisogno
terapeutico del paziente. - Tuttavia, non tutte le carenze di medicinali
rappresentano un problema concreto per il cittadino.
Farmaci
carenti per i quali sono disponibili medicinali equivalenti
Farmaci
carenti per i quali è disponibile un trattamento terapeutico alternativo
Farmaci
carenti per i quali AIFA può autorizzare l'importazione
Elenco
Farmaci Carenti
FarmacoVigilanza
EMA
Agenzia Europea per i Medicinali
Periodic safety update report single
assessment
Le valutazioni singole dei rapporti
periodici di aggiornamento sulla sicurezza (PSUSA)
sono valutazioni singole dei rapporti periodici di aggiornamento sulla
sicurezza (PSUR) correlati per i
principi attivi contenuti in medicinali autorizzati nell'Unione Europea (UE).
Uno PSUR è un rapporto di farmacovigilanza presentato regolarmente dal titolare
di un'autorizzazione all'immissione in commercio a intervalli temporali
definiti dopo l'autorizzazione di un medicinale.
propylthiouracil
Giurisprudenza
Sanitaria Farmaceutica
Corte
di Cassazione (Ordinanza del 23 novembre 2025 n.30777)
Dirigenti
Medici
Secondo la Suprema Corte il principio, sancito
dall’art. 65 del CCNL 5 dicembre 1996, secondo cui la corresponsione di una retribuzione di risultato compensativa anche
dell’eventuale superamento dell’orario lavorativo per il conseguimento
dell’obiettivo assegnato esclude il diritto al compenso per lavoro
straordinario, si applica anche al personale dirigente di struttura in posizione
non apicale, rispondendo ad esigenze comuni all’intera dirigenza e ad una
lettura sistematica delle norme contrattuali, che, ove hanno inteso riconoscere
(come per l’attività connessa alle guardie mediche) una compensazione delle ore
straordinarie per i dirigenti medici, lo hanno specificamente previsto. -
Pertanto, si è ritenuto che l’art. 60 del CCNL del 3 novembre 2005, confermando
nelle parti non modificate o integrate o disapplicate tutte le disposizioni
sull’orario di lavoro e l’orario notturno contenute nei CCNL 8 giugno 2000 e 5
dicembre 1996, lascia ferma l’esclusione del diritto del dirigente medico ad
essere compensato per lavoro straordinario, senza che sia possibile la
distinzione tra il superamento dell’orario di lavoro preordinato al raggiungimento
dei risultati assegnati e quello imposto da esigenze del servizio ordinario,
poiché la sua prestazione deve essere svolta complessivamente al fine di
conseguire gli obiettivi propri ed immancabili dell’incarico affidatogli. - Ciò
significa che la flessibilità oraria prevista per la prestazione di lavoro dei
dirigenti medici ha lo scopo primario di favorire il raggiungimento degli
obiettivi da parte della struttura sanitaria, tant’è che l’orario di trentotto
ore settimanali è da intendere come orario minimo e può essere superato senza
che sia dovuto il pagamento dello straordinario. - Autore: Chiara di Lorenzo - Ufficio Legislativo FNOMCeO
Rassegna
Sanitaria Farmaceutica
Egualia
(Industrie Farmaci Accessibili)
XII
Rapporto sulla povertà sanitaria: oltre 500mila senza cure
Quest'anno 501.922 persone - 8,5 residenti su 1.000 +8,4% rispetto al
2024 - si sono trovate in condizioni di povertà sanitaria, ovvero hanno dovuto
chiedere aiuto a una delle 2.034 realtà assistenziali convenzionate con Banco
Farmaceutico per ricevere gratuitamente farmaci e cure che, altrimenti, non
avrebbero potuto permettersi. Il dato emerge dal XII Rapporto OPSan,
l'Osservatorio sulla Povertà Sanitaria del Banco Farmaceutico, presentato oggi
nella sede dell'AIFA.
NBST
Network Bibliotecario Sanitario Toscano
Cardiomiopatia
peripartum: una malattia cardiaca rara ma con conseguenze serie in gravidanza
- La cardiomiopatia peripartum è una malattia cardiaca relativamente rara, che
si manifesta nella fase finale della gravidanza o nei primi mesi dopo il parto
in donne senza storia di patologie cardiovascolari.
CPO
Centro di Riferimento per l'Epidemiologia e la Prevenzione Oncologica in
Piemonte
Unmasking
pandemic patterns: decoding the COVID-19's impact on mortality in Italy
with Generalized Gamma overdispersion model
OTA
Osservatorio Terapie Avanzate
Nuove
nanoparticelle per vaccini a mRNA: efficacia con dosi 100 volte minori
- Lo studio del MIT è stato pubblicato su Nature Nanotechnology e apre
importanti prospettive per vaccini a mRNA più potenti, più economici e meglio
tollerati
OMAR
Osservatorio Malattie Rare
Qual
è il momento migliore per fare lo screening uditivo ai neonati? - Un
recente studio indica le 37-48 ore dopo la nascita come la finestra ottimale
del test, allo scopo di ridurre i falsi positivi
British Journal of Clinical Pharmacology
Population pharmacokinetics of levofloxacin
in breastmilk in patients with rifampicin-resistant
tuberculosis
British Journal of Clinical Pharmacology
Penicillin
allergy de-labelling in the critical care unit: Simulations to design
an intravenous drug provocation test that mirrors the plasma profile of an
enteral challenge
British Journal of Clinical Pharmacology
Mitigating subtherapeutic cabozantinib
exposure after prior mitotane therapy in adrenocortical carcinoma:
Pharmacological boosting with cobicistat
The Lancet
Tinengotinib
for adults with advanced or metastatic cholangiocarcinoma: a multicentre,
open-label, phase 2 trial
ASCO American Society of Clinical
Oncology
Development of a Dynamic
Counterfactual Risk Stratification Strategy for Newly Diagnosed Patients With
AML Treated With Venetoclax
and Azacitidine
MDPI Multidisciplinary Digital
Publishing Institute
Trastuzumab-Conjugated
pH-Sensitive Micelles Exhibit Antitumor Activity and Induce Mesenchymal-to-Epithelial
Transition in Triple-Negative Breast Cancer Cell Lines
MDPI Multidisciplinary Digital
Publishing Institute
Development and
Validation of LC-MS/MS Method for Nintedanib and BIBF 1202
Monitoring in Plasma of Patients with Progressive Pulmonary Fibrosis Associated
with Systemic Sclerosis
JAC Antimicrobial Resistance (Oxford
Academic)
VRE
and antibiotic use in German ICUs - an ecological analysis of 15 years of surveillance
data
JAC Antimicrobial Resistance (Oxford
Academic)
Bacterial
and fungal pathogens causing neonatal sepsis and associated antimicrobial
resistance in South African neonatal units-a systematic review
JAC Antimicrobial Resistance (Oxford
Academic)
In vitro sulbactam/avibactam
synergy against carbapenem-resistant Acinetobacter baumannii from hospitals in
Peru
JAC Antimicrobial Resistance (Oxford
Academic)
How
to utilize routine antimicrobial resistance surveillance data for local
and national actions in an LMIC
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
Dispositivi
Medici (Avvisi di sicurezza nazionali ed internazionali)
FDA Food and Drug Administration
Early
Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
This communication is an
FDA Early Alert. The FDA has become aware of a potentially high-risk issue. The
FDA will keep the public informed and update this web page as significant new
information becomes available. - Affected Product - The FDA is aware that
Abbott Diabetes Care has issued a letter to distributors, health care
providers, and affected customers recommending certain glucose monitor sensors
be removed from where they are used or sold:
Ministero della Salute
OLYMPUS
MEDICAL SYSTEM CORPORATION - SNAREMASTER PLUS HOT/COLD
MEDLINE
INTERNATIONAL FRANCE SAS - KIT EXTRAVASCOLARE RADIOLOGIA INT.CA
DIETER
MARQUARDT MEDIZINTECHNIK GMBH - VITUS-FI DISTAL FIBULA NAIL Ø 3.6MM, L 145MM
AB MEDICA SPA - EASYKIT
SMITH
& NEPHEW INC - BIOSURE
MEDNET
GMBH - COLOUR CODED SYRINGE, PC
MICRO
THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR - TUBO DI CONNESSIONE AD AMPIO LUME
PER ASPIRAZIONE RIPTIDE
NOXBOX
LTD - NOXBOXI
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