Novità
Sanitarie Farmaceutiche
FDA Food and Drug Administration
FDA
removes risk evaluation and mitigation strategy (REMS) program for the
antipsychotic drug Clozapine
Neutropenia Risk Remains, but REMS
No Longer Necessary and REMS May Prevent Treatment Access
MHRA Medicines and Healthcare products
Regulatory Agency
MHRA
approves UK’s first new type of antibiotic for urinary tract infections in
nearly 30 years
As with any medicine, the MHRA will keep the safety of
gepotidacin under close review.
The Medicines and Healthcare
products Regulatory Agency (MHRA) has approved gepotidacin
(Blujepa) , a new kind of oral antibiotic pill to treat uncomplicated
urinary tract infections (UTIs) in females aged 12 years and older, weighing at
least 40 kg. Uncomplicated UTIs are the most common bacterial infection in
women, affecting around half of females in the UK. With drug-resistant bacteria
increasing, new treatment options are critical in preventing treatment failure
and complications, including sepsis or permanent kidney damage. The active
ingredient in the antibiotic targets and blocks two enzymes that bacteria need
to replicate and multiply, making it effective against many drug resistant
infections such as E. coli.
MHRA Medicines and Healthcare products
Regulatory Agency
MHRA
approves zuranolone to treat postnatal depression in adults following
childbirth
As with any medicine, the MHRA will keep the safety of
zuranolone under close review
The Medicines and Healthcare
products Regulatory Agency (MHRA) has approved zuranolone (brand name: Zurzuvae)
to treat moderate or severe postnatal depression (PND) in adults following
childbirth. Postnatal depression is a type of depression that many parents
experience after having a baby. It is a common problem, affecting more than 1
in every 10 women within a year of giving birth. Common symptoms of PND include
persistent feelings of sadness or inadequacy, irritability, anxiety about their
baby’s wellbeing, and loss of interest in previously enjoyable activities,
accompanied by physical manifestations such as extreme fatigue, disrupted sleep
patterns, and changes in appetite.
Zuranolone is the first oral treatment for postnatal depression approved
in the UK. The MHRA conducted a rigorous assessment of the safety, quality, and
efficacy of zuranolone
MHRA Medicines and Healthcare products
Regulatory Agency
MHRA
launches Route B notification pilot as part of clinical trials regulations
rollout
The pilot will help sponsors prepare
for a new substantial modifications process under upcoming regulations, with
responses delivered within 14 days. The Medicines and Healthcare products
Regulatory Agency (MHRA) is launching a pilot from 1 October 2025 to 31 March
2026 to streamline the approval process for certain changes to clinical trials,
as part of preparations for new clinical trials regulations coming into effect
on 28 April 2026. The pilot will expand the MHRA’s risk-proportionate approach
to include the review of modifications to approved clinical trial applications.
Under the new regulations, substantial modifications can be granted automatic
approval through the Route B substantial modification process, providing they
meet eligibility criteria.
NICE National Institute for Health and
Care Excellence
Pembrolizumab with
carboplatin and paclitaxel for untreated primary advanced or recurrent
endometrial cancer
Evidence-based recommendations on
pembrolizumab (Keytruda)
with carboplatin and paclitaxel for untreated primary advanced or recurrent
endometrial cancer. - Last reviewed: 27
August 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
Idebenone for treating visual
impairment in Leber’s hereditary optic neuropathy in people 12 years and over
Evidence-based recommendations on
idebenone (Raxone)
for treating visual impairment in Leber’s hereditary optic neuropathy in people
12 years and over. - Last reviewed: 28
August 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
Guselkumab for treating
moderately to severely active ulcerative colitis
Evidence-based recommendations on
guselkumab (Tremfya)
for treating moderately to severely active ulcerative colitis in adults. - Last reviewed: 28 August 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
Guselkumab for previously
treated moderately to severely active Crohn's disease
Evidence-based recommendations on
guselkumab (Tremfya)
for previously treated moderately to severely active Crohn's disease. - Last reviewed: 28 August 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
Bed frames for adults in acute
medical or surgical hospital wards: late-stage assessment
Late stage assessment (LSA) guidance
on bed frames for adults in acute medical or surgical hospital wards. - Last reviewed: 27 August 2025 -
Guidance development process - LSA guidance evaluates categories of
technologies that are already in widespread use within the NHS. It assesses
whether price variations between technologies in a category are justified by
differences in innovation, clinical effectiveness and patient benefits. This
will support NHS commissioners, procurement teams, patients and healthcare
professionals to choose technologies that maximise clinical effectiveness and
value for money.
NICE National Institute for Health and
Care Excellence
Compression products for
treating venous leg ulcers: late-stage assessment
Late-stage assessment (LSA) guidance
on compression products for treating venous leg ulcers. - Last reviewed: 27 August 2025 - Guidance development process- LSA
guidance evaluates categories of technologies that are already in widespread
use within the NHS. It assesses whether price variations between technologies
in a category are justified by differences in innovation, clinical
effectiveness and patient benefits. This will support NHS commissioners,
procurement teams, patients and healthcare professionals to choose technologies
that maximise clinical effectiveness and value for money.
SNLG Sistema Nazionale Linee Guida (ISS)
La
diagnosi e la terapia dell’obesità Duplica 1
L’obesità
e le sue complicanze sono un problema di salute pubblica in crescita in molti
paesi, a causa dell’aumento della prevalenza, dell’impatto rilevante sulla
salute degli individui affetti e del crescente peso economico correlato. I
trattamenti per l’obesità che includono sia interventi sullo stile di vita che
terapie farmacologiche, sono spesso caratterizzati da scarsa efficacia a lungo
termine. La terapia educazionale, farmacologica, endoscopica e
metabolica/bariatrica sono tutte armi a disposizione del clinico coinvolto nel
trattamento di questa patologia cronica e le sue complicanze quali il Diabete
Mellito Tipo 2 (DM2), la sindrome delle apnee ostruttive del sonno (OSAS), ecc.
Tuttavia, l’utilizzo di approcci farmacologici e chirurgici è stato finora
contenuto a causa di limitazioni organizzative ed economiche. Lo sviluppo di
linee guida rigorose migliora l’appropriatezza delle scelte terapeutiche ed è
quindi uno strumento rilevante per il miglioramento della qualità delle cure.
L’Istituto Superiore di Sanità ha riconosciuto questa necessità e ha deciso di
affidare alla Società Italiana dell'Obesità (SIO) di progettare e sviluppare
delle linee guida italiane, con l'obiettivo di assistere gli operatori sanitari
dalla diagnosi al trattamento, orientandoli nella scelta terapeutica più
appropriata sulla base delle evidenze scientifiche disponibili. Lo scopo
della linea guida è quello di fornire un riferimento per la diagnosi ed il
trattamento del sovrappeso, obesità e delle patologie ad esse correlate, in soggetti
adulti.
ECHA European Chemicals Agency
ECHA
announces timeline for PFAS restriction evaluation
The European Chemicals Agency (ECHA)
aims to complete its scientific evaluation of the proposed EU-wide restriction
on per- and polyfluoroalkyl substances (PFAS) by the end of 2026. - Helsinki,
27 August 2025 – In a note, published today, ECHA provides an update on its
assessment of the proposal and clarifies the expected timeline. This follows
the publication of the updated restriction proposal, which took place on 20
August 2025.
Commissione
Europea
Decisioni
di esecuzione della Commissione Europea sui medicinali orfani con le
seguenti indicazioni terapeutiche e principio attivo
(Orphan designation - Corrigendum - Transfer of orphan
designation - Change of name and/or address of sponsor):
Omissis
- Treatment of lymphoplasmacytic lymphoma
Alpibectir,
ethionamide - Treatment of tuberculosis
Commissione
Europea
Selezione
delle novita’ sui medicinali uso umano pubblicate sul sito web della CE
Nuove Autorizzazioni -
Modifiche e Comunicazioni pubblicate sui seguenti medicinali:
Yeytuo (lenacapavir) – Centralised Authorisation
Yeytuo
injection is indicated in combination with safer sex practices for pre-exposure
prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in
adults and adolescents with increased HIV 1 acquisition risk, weighing at least
35 kg (see sections 4.2, 4.4 and 5.1 of the SmPC
Nintedanib
(Viatris) – Centralised Authorisation
Nintedanib
Viatris is indicated in adults for the treatment of idiopathic pulmonary
fibrosis (IPF). - Nintedanib Viatris is also indicated in adults for the
treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a
progressive phenotype. - Nintedanib Viatris is indicated in children and
adolescents from 6 to 17 years old for the treatment of clinically significant,
progressive fibrosing interstitial lung diseases (ILDs). - Nintedanib Viatris
is indicated in adults, adolescents and children aged 6 years and older for the
treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Zemcelpro
(dorocubicel / allogeneic umbilical cord-derived CD34- cells, non-expanded)
- Centralised Authorisation
Zemcelpro is
indicated for the treatment of adult patients with haematological malignancies
requiring an allogeneic haematopoietic stem cell transplantation following
myeloablative conditioning for whom no other type of suitable donor cells is
available.
Usymro
(ustekinumab) - Centralised Authorisation
Abecma
(idecabtagene vicleucel)
Alhemo (concizumab)
Baqsimi (glucagon)
Clopidogrel (Zentiva)
Imnovid (pomalidomide)
Invokana (canagliflozin)
Roclanda (latanoprost – netarsudil)
Sirturo (bedaquikine)
Taltz (ixekizumab)
Tevimbra (tislelizumab)
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:
Betmiga
(mirabegron)
Enzalutamide
(Viatris)
Icatibant
(Accord)
Itovebi
(inavolisib)
Kyntheum
(brodalumab)
Laventair Ellipta (umeclidinium bromide –
vilanterol)
Lixiana
(edoxaban)
Nilotinib
(Accord)
Pregabalin
(Accord)
Revolade
(eltrombopag)
Roteas
(edoxaban)
Tabrecta
(capmatinib)
Zypadhera
(olanzapine) – Supply Shortage
AIFA
Agenzia Italiana del Farmaco
Banca Dati Farmaci (Aggiornamento del 27 agosto 2025)
Ultimi medicinali autorizzati:
AKELYA - Italfarmaco
S.p.a.
NINTEDANIB SANDOZ -
Sandoz S.p.a.
FUNGOTILL LIPOSOMIALE
- Tillomed Italia Srl
TICAGRELOR AUROBINDO
- Aurobindo Pharma (Italia) S.r.l.
BILASTINA
AMAROX - Amarox Pharma Bv
AKYNZEO
- Abacus Medicine A/s
ZESTRIL
- Farmed S.r.l.
KIPLING
- Farmed S.r.l.
VICKS
VAPORUB - New Pharmashop S.r.l.
DAYLETTE - Bb Farma
S.r.l.
AIFA
Agenzia Italiana del Farmaco
Carenza
ESOMEPRAZOLO TILLOMED - modalità di richiesta d'importazione dall'estero
L'Agenzia Italiana del Farmaco rende disponibili aggiornamenti
relativi al medicinale “ESOMEPRAZOLO TILLOMED (esomeprazolo) 40 mg polvere per
soluzione per infusione 10 flaconcini in vetro da 5 ml (A.I.C. 047977020)”, non
reperibile sul territorio nazionale per il quale è stata autorizzata
l’importazione dall’estero su richiesta dell’azienda.
FDA
Food and Drug Administration
Pubblicazioni delle nuove autorizzazioni
all’immissione in commercio (Orig-1) dei seguenti farmaci:
CAMCEVI
ETM (LEUPROLIDE MSEYLATE) - Type 5 - New Formulation or New
Manufacturer
SODIUM
BICARBONATE (FRESENIUS KABI USA)
MELPHALAN (ALEMBIC GLOBAL) - Tentative Approval
DASATINIB (LUPIN)
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
durvalumab
(Imfinzi)
Rassegna
Sanitaria Farmaceutica
OMAR
Osservatorio Malattie Rare
Individuato
il meccanismo patologico alla base della SAVI, una rara vasculite a esordio
infantile - Uno studio congiunto tra Università di Colonia e Ospedale
Bambino Gesù apre nuove strade nella ricerca di terapie per le malattie
autoinfiammatorie legate alla proteina STING
ESMO European Society for Medical
Oncology
Combining Enzalutamide
with Radium-223
Significantly Improves rPFS as First-Line Therapy for Patients with mCRPC -
Findings from the PEACE-3 study
ASCO American Society of Clinical
Oncology
ASCO
Approves First Guideline on Cancer-Specific Geriatric Assessment of
Older Patients in Resource-Limited Settings
The Lancet
TAR-200 plus cetrelimab
versus cetrelimab monotherapy as neoadjuvant therapy in patients with
muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based
chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2
trial
The Lancet
Bictegravir,
emtricitabine,
and tenofovir
alafenamide versus ritonavir-boosted
protease inhibitor-based antiretroviral therapy in people with HIV and viral
suppression on second-line therapy in Haiti: an open-label, randomised,
non-inferiority trial
MDPI Multidisciplinary Digital
Publishing Institute
Targeted Fluoxetine Delivery
Using Folic Acid-Modified
PLGA Nanoparticles for Selective Uptake by Glioblastoma Cells
Istituto
di Ricerche Farmacologiche Mario Negri IRCCS
Febbre
West Nile: cos'è la febbre del Nilo? - La febbre del Nilo Occidentale
(o febbre West Nile) è una malattia infettiva virale causata dal virus West
Nile, trasmesso dalle punture di zanzara. Come riconoscerla, dove è più
diffusa, quando diventa pericolosa o mortale.
Istituto
di Ricerche Farmacologiche Mario Negri IRCCS
Autismo:
cos'è, sintomi e disturbi dello spettro autistico - Come riconoscere l'autismo,
le cause, i segnali, i sintomi, l'importanza di una diagnosi precoce: tutto sul
disturbo dello spettro autistico e le sue diverse manifestazioni.
PubMed
Apixaban Versus Aspirin to Reduce Cognitive
Decline After Cryptogenic Stroke and Atrial Cardiopathy: ARCADIA-Cognition
Study
Istituto
di Ricerche Farmacologiche Mario Negri IRCCS
Cardioaspirina:
cos'è, a cosa serve e come funziona - La cardioaspirina è uno dei farmaci più
utilizzati nella prevenzione di eventi cardiovascolari come infarti e ictus
grazie alla sua azione antiaggregante. Scopri come funziona, quando è indicata
e quali sono i possibili rischi ed effetti collaterali.
Le Aziende Farmaceutiche Informano
AbbVie
AbbVie to Acquire Gilgamesh
Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major
Depressive Disorder, Expanding Psychiatry Pipeline - Gilgamesh's lead asset, bretisilocin
(GM-2505), is a potential best-in-class psychedelic compound currently in Phase
2 development for the treatment of major depressive disorder (MDD) -
Bretisilocin is a novel, short-acting serotonin
(5-HT)2A receptor agonist and 5-HT releaser
AbCellera
AbCellera Doses First Participants
in a Phase 1 Clinical Trial of ABCL575
- ABCL575 is an Fc-silenced, half-life extended investigational antibody
therapy that is being developed for the treatment of atopic dermatitis
Antiva Biosciences
Antiva Biosciences Announces
Positive Top-Line Results from Phase 1b/2 Study of ABI-2280 for
Treatment of Cervical High-Risk Human Papillomavirus (hrHPV) Infection - Study
Achieves Primary and all Secondary Endpoints Demonstrating Clinically
Meaningful, Statistically Significant Improvements in hrHPV Negativity at Week
12 as Compared to Placebo - 46% of Patients Treated with 3 mg Cumulative Dose
for Two Weeks Demonstrated Negativity for hrHPV at Week 12 as Compared to 16%
for Placebo Group - ABI-2280 Efficacy was Durable, with 87% of Responders at
Week 12 Maintaining hrHPV Negativity at Week 24 based on Interim Data Treatment
Shown to be Safe and Well Tolerated with Most Common Adverse Events Categorized
as Mild or Moderate and Localized to Treatment Area
Ascletis
Ascletis Announces Favorable and
Differentiated Pharmacokinetic Profile of ASC30
Oral Once-Daily Tablet in Its U.S. Phase Ib Multiple Ascending Dose Study -
ASC30 oral once-daily tablet demonstrated approximately 2.3-fold to 3.3-fold
greater drug exposure than orforglipron in a cross-trial comparison - Higher
drug exposure and favorable tolerability profile positions ASC30 oral
once-daily tablet favorably compared to orforglipron
- Topline data from the Ascletis’ U.S. Phase IIa study for ASC30 in
participants with obesity or overweight are expected in the fourth quarter of
2025
Azitra
Azitra, Inc. Announces First Patient
Dosed in Phase 1/2 Trial for ATR-04 Program Targeting Oncology Patients with EGFRi-Associated
Rash - Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical
stage biopharmaceutical company focused on developing innovative therapies for
precision dermatology, today announced the dosing of the first patient in its
Phase 1/2 clinical trial of ATR04-484,
a topically applied live biotherapeutic product candidate designed to treat
EGFR inhibitor ("EGFRi")-associated rash. Azitra has received Fast
Track designation from the FDA for EGFRi associated rash, which impacts
approximately 150,000 people in the U.S. annually.
Bayer
Gadoquatrane
New Drug Application Accepted for Review by U.S. FDA - New Drug Application
(NDA) for low dose contrast agent gadoquatrane seeks approval for
contrast-enhanced magnetic resonance imaging (MRI) of the central nervous
system (CNS) and other body regions for adults and pediatric patients including
neonates / Submitted dose corresponds to a 60 percent reduction in gadolinium
compared to macrocyclic
gadolinium-based contrast agents (GBCAs) dosed at 0.1 mmol gadolinium
per kilogram of body weight
ExCellThera
Zemcelpro
(UM171 Cell Therapy) receives EC authorization as the first and only
cell therapy for blood cancer patients without access to suitable donor cells -
Zemcelpro is conditionally authorized by the European Commission for adults
with haematological malignancies requiring an allogeneic haematopoietic stem
cell transplantation following myeloablative conditioning for whom no other
type of suitable donor cells is available - Zemcelpro will increase access to
allogeneic stem cell transplantation to treat life-threatening haematologic
malignancies, including leukemias and myelodysplastic syndromes - Timing of
Zemcelpro availability in individual countries will depend on several factors,
including the completion of national reimbursement procedures - Cordex
Biologics, an ExCellThera company, is actively seeking strategic partnerships
to accelerate the commercialization of Zemcelpro in Europe and other markets
Immuno Precise Advances
ImmunoPrecise Advances AI Discovered
and Developed Universal Dengue
Vaccine Initiative: Moves into Preclinical Antibody Generation -
Manufacturing of validated dengue epitope underway; proprietary immunization
studies in rabbit model to assess monoclonal antibody (mAb) responses
Merck
HERTHENA-Breast04 Phase 3 Trial of Patritumab
Deruxtecan Initiated in Patients with Metastatic Hormone Receptor
Positive, HER2 Negative Breast Cancer Previously Treated with Endocrine Therapy
- The first patient has been dosed in the HERTHENA-Breast04 phase 3 trial
evaluating the efficacy and safety of investigational patritumab deruxtecan
(HER3-DXd) versus investigator’s choice of treatment in patients with
unresectable locally advanced or metastatic hormone receptor (HR) positive,
HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer with disease
progression following endocrine and CDK4/6 inhibitor therapy in either the
adjuvant or first-line metastatic settings.
NRx Pharmaceuticals
NRx Pharmaceuticals, Inc.
(NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100
(preservative-free ketamine) - US Food and Drug Administration (FDA)
has granted Fast Track designation for NRX-100 in the treatment of suicidal
ideation in patients with depression, including bipolar depression. - NRx
Pharmaceuticals is making NRX-100 available on an expanded access basis upon
physician request for patients with serious or life-threatening suicidal
depression despite treatment with currently available therapy. - Approximately
13 million adults seriously consider suicide each year, according to the CDC.
An American dies from suicide every 11 minutes.
Pfizer
Pfizer and BioNTech’s COMIRNATY
Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5
through 64 at Increased Risk for Severe COVID-19 - The 2025-2026 COVID-19
vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA
guidance to more closely match circulating strains - Shipping of the
LP.8.1-adapted vaccine will begin immediately to ensure robust supply and rapid
access of this season’s vaccine in pharmacies, hospitals, and clinics across
the country
Dispositivi
Medici (Avvisi di sicurezza)
Ministero
della Salute
MEDLIGHT
- N-LINEPRO UVB 311NM - N-LINEPRO UVA - N-LINEPRO UNIVERSAL
QUIDEL CORPORATION - TRIAGE TROPONIN
I TEST
GETINGE DISINFECTION AB - GETINGE CM
320-4 WWWD LAVASTRUMENTI MULTICAMERA A 4 PORTE
FDA Food and Drug Administration
Early
Alert: Automated Impella Controller Issue from Abiomed - This
communication is part of the Communications Pilot to Enhance the Medical Device
Recall Program. The FDA has become aware of a potentially high-risk device
issue. The FDA will keep the public informed and update this web page as
significant new information becomes available
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