Novità
Sanitarie Farmaceutiche
MHRA Medicines and Healthcare products
Regulatory Agency
Pharmacovigilance
following agreement of the Windsor Framework
Information on the implementation of
changes to pharmacovigilance for medicines authorised in the UK following the
agreement of the Windsor Framework.
Last updated - 11 March 2025: Updated to remove: “1. Subject to
the UK providing written guarantees to the European Commission as provided for
in Article 8 of EU Regulation 2023/1182 and following the entry into force and
application procedure provided for in Article 14” from document
Pharmacovigilance following agreement of the Windsor Framework.
Advertising
and Promotion following agreement of the Windsor Framework
This guidance is designed to provide
information on the implementation of changes to advertising and promotion of
medicines authorised in the UK from 1 January 2025.
Last updated: 11 March 2025 - Updated to remove footnote: '1. Subject to the UK
providing written guarantees to the European Commission as provided for in
Article 8 of EU Regulation 2023/1182 and following the entry into force and
application procedure provided for in Article 14'
FDA Food and Drug Administration
Immune
Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary
Lot Withdrawals - Due to Increased Reports of Allergic/Hypersensitivity
Reactions
ISSUE: As a precautionary measure, the following lots of
Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have
been voluntarily withdrawn by the manufacturers due to a higher rate of
allergic/hypersensitivity type reactions, some of which were considered
medically significant. BACKGROUND: Hypersensitivity and
anaphylactic/anaphylactoid reactions are a known risk with immune globulin
products.
RECOMMENDATIONS: Please examine your stock
immediately to determine if you have any vials from these lots. - If you have product from these lots, please
cease use immediately. - Return the affected
product to the point of purchase to receive replacement product.
NICE National Institute for Health and
Care Excellence
Zolbetuximab with
chemotherapy for untreated claudin-18.2-positive HER2-negative unresectable
advanced gastric or gastro-oesophageal junction adenocarcinoma
Evidence-based recommendations on
zolbetuximab (Vyloy)
with chemotherapy for untreated claudin-18.2-positive HER2-negative
unresectable advanced gastric or gastro-oesophageal junction adenocarcinoma in
adults.
Last reviewed: 12 March 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
Atezolizumab for untreated
advanced or recurrent non-small-cell lung cancer when platinum-doublet
chemotherapy is unsuitable (terminated appraisal)
NICE is unable to make a recommendation
about the use in the NHS of atezolizumab (Tecentriq) for
untreated advanced or recurrent non-small-cell lung cancer when
platinum-doublet chemotherapy is unsuitable in adults. This is because Roche
Products did not provide an evidence submission.
Last reviewed: 12 March 2025: Next review: We will review this
decision if the company decides to make an evidence submission.
EMA
Agenzia Europea per i Medicinali
Orphan Designation:
EMA publishes
information on orphan medicinal product designation adopted by the Committee
for Orphan Medicinal Products (COMP)
Adeno-associated
virus sector serotype rh74 containing the human SGCG gene - treatment
of limb-girdle muscular dystrophy
Autologous
CD34+ cell enriched population containing haematopoietic stem and progenitor
cells transduced ex vivo with a lentiviral vector encoding the human ADA2 gene
- treatment of adenosine deaminase 2 deficiency (DADA2)
Epertinib
- treatment of amyotrophic lateral sclerosis
Volixibat
potassium - treatment of primary sclerosing cholangitis
Adeno-associated
virus vector serotype SNY001 containing the human PAH gene - treatment of hyperphenylalaninaemia
Paltusotine - treatment of
acromegaly
Human
immunoglobulin G1 - X-linked hypohidrotic ectodermal dysplasia
(Christ-Siemens-Touraine Syndrome)
Venetoclax
- diffuse large B-cell lymphoma
(R)-(3-(2'-cyclopropyl-3-(hydroxymethyl)-[1,1'-biphenyl]-4-yl)pyrrolidin-1-yl)(5-hydroxy-6-methylpyridin-2-yl)methanone
- Olmsted syndrome
Adeno-associated
virus serotype rh.10 containing the human PKP2 gene - arrhythmogenic
cardiomyopathy caused by pathogenic mutations in the PKP2 gene
Venetoclax
- mantle cell lymphoma
Hydroxocobalamin
acetate - homocystinuria and/or methylmalonic acidaemia due to genetic
defects of intracellular cobalamin processing
Rimeporide - Duchenne muscular dystrophy
Tafasitamab - follicular lymphoma
EMA Agenzia Europea per i Medicinali
Prime:
Priority Medicines (Last Updated: 11/03/2025)
PRIME
è un programma gestito dall'Agenzia europea per i medicinali (EMA) per
potenziare il sostegno allo sviluppo di farmaci mirati a un'esigenza medica
insoddisfatta. Questo schema volontario si basa su una migliore interazione e un
dialogo tempestivo con gli sviluppatori di farmaci promettenti, per ottimizzare
i piani di sviluppo e accelerare la valutazione in modo che questi farmaci
possano raggiungere i pazienti prima
List
of medicines currently in PRIME scheme
Recommendations
on eligibility to PRIME scheme - Adopted at the CHMP meeting 24-27 February
2025
EMA
Agenzia Europea per i Mdicinali
Nuove Autorizzazioni
- Modifiche - Comunicazioni pubblicate sui seguenti farmaci:
Andembry (garadacimab)
mResvia (Single-stranded 5' capped
mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the
prefusion conformation)
Paxneury
(guanfacine)
Quetiapine (Supply Shortage)
Rybrevant (amivantamab)
Rytelo (imetelstat)
Uzpruvo (ustekinumab)
AIFA
Agenzia Italiana del Farmaco
Epatite
C: aggiornamento del 10 marzo 2025 sui pazienti arruolati
L'Agenzia Italiana del Farmaco rende disponibile l’aggiornamento
settimanale dei dati relativi ai trattamenti con i nuovi farmaci ad azione
antivirale diretta di seconda generazione (DAAs) per la cura dell’epatite C
cronica, raccolti dai Registri di monitoraggio AIFA.
AIFA
Agenzia Italiana del Farmaco
Banca Dati Farmaci (Aggiornamento del 11 marzo 2025)
Ultimi medicinali autorizzati:
FRIPASS - Bb Farma
S.r.l.
KYLEENA - Bb Farma
S.r.l.
XALATAN - Abacus
Medicine A/s
LANSOPRAZOLO SUN PHARMA
- Sun Pharmaceutical Industries (Europe) B.v.
ATLIMARBAI -
Sigillata Limited
DALBAVANCINA TEVA -
Teva B.v.
DABIGATRAN ETEXILATO MEDICAL
VALLEY - Medical Valley Invest Ab
TICAGRELOR ABDI -
Abdi Farma Gmbh
ZARONTIN - Gmm Farma
S.r.l.
ENZALUTAMIDE ACCORD -
Accord Healthcare, S.l.u.
Ultime confezioni
autorizzate:
XALATAN
- 50 MICROGRAMMI/ML COLLIRIO, SOLUZIONE 1 FLACONE IN LDPE DA 2,5 ML
FRIPASS
- 100 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/AL
KYLEENA
- 19,5 mg sistema a rilascio intrauterino – 1 sistema a rilascio intrauterino
KYLEENA
- 19,5 mg sistema a rilascio intrauterino – 1 sistema a rilascio intrauterino
DEXMEDETOMIDINA
B. BRAUN - 4 MICROGRAMMI/ML SOLUZIONE PER INFUSIONE 10 FLACONI DA 50 ML
IN PE
ATLIMARBAI
- 10 MG/G GEL 1 TUBO IN AL DA 50 G
ATLIMARBAI
- 10 MG/G GEL 1 TUBO IN AL DA 30 G
DALBAVANCINA
TEVA - 500 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE 1
FLACONCINO IN VETRO
DEXMEDETOMIDINA
B. BRAUN - 8 MICROGRAMMI/ML SOLUZIONE PER INFUSIONE 10 FLACONI DA 50 ML
IN PE
DEXMEDETOMIDINA
B. BRAUN - 4 MICROGRAMMI/ML SOLUZIONE PER INFUSIONE 10 FLACONI DA 100
ML IN PE
FDA
Food and Drug Administration
Pubblicazioni delle nuove autorizzazioni
all’immissione in commercio (Orig-1) dei seguenti farmaci:
Arformoterol
tartrate (Micro Labs)
Ketoconazole
(Zydus Lifesciences)
CDA-AMC
Canada’s Drug Agency - L’Agence des Medicaments du Canada - Novita’ sui Farmaci
(N/A) means not available (brand name is not available)
(TBC) means to be confirmed (brand name
is still to be confirmed)
(TBD) The Brand Name is to be determined
Glofitamab (Columvi)
Nemolizumab (TBC)
Pasireotide (Signifor LAR)
Pegcetacoplan (TBC)
CDA-AMC
Canada’s Drug Agency - L’Agence des Medicaments du Canada – Report
The
Cost-Effectiveness and Budget Impact of Nirmatrelvir-Ritonavir for COVID-19
The
Cost-Effectiveness and Budget Impact of Remdesivir for Outpatient Treatment of
COVID-19
The
Cost-Effectiveness and Budget Impact of Tocilizumab for COVID-19
The
Cost-Effectiveness and Budget Impact of Remdesivir for Inpatient Treatment of
COVID-19
MHRA Medicines and Healthcare products
Regulatory Agency
Class
4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11
Jubilant Pharmaceuticals NV has
informed the MHRA that the Patient information leaflet (PIL) in the cartons for
the batches listed in the table include an outdated PIL. These packs contain a
PIL which was revised in October 2021. The
latest approved PIL is dated February 2025.
Giurisprudenza
Sanitaria Farmaceutica
Corte
di Cassazione (Ordinanza del 02 marzo 2025 n.5501)
Dirigenti
Medici
La Suprema Corte ha affermato che il dirigente medico che eserciti un’azione di esatto adempimento non
può ottenere nulla più della retribuzione mensile a lui spettante, la quale
è stabilita, su base mensile e non oraria, in misura omnicomprensiva di tutte
le prestazioni dal medesimo rese, senza che il suo ammontare abbia nulla a che
vedere con il tempo effettivo dedicato al lavoro. In particolare, egli non ha
diritto ad essere compensato per il lavoro eccedente rispetto all’orario
indicato dalla contrattazione collettiva, pure se esso sia dipeso dall’erroneo
criterio di calcolo adottato dall’ASL per determinare il debito orario minimo
assolto; in tale evenienza, potrà eventualmente far valere la responsabilità
datoriale a titolo risarcitorio, ove abbia patito un pregiudizio concreto alla
salute, alla personalità morale o al riposo, che dovrà specificamente allegare
e provare, anche attraverso presunzioni semplici. - Autore: Chiara di Lorenzo - Ufficio Legislativo FNOMCeO
Rassegna Sanitaria Farmaceutica
L'industria farmaceutica lancia un appello all'azione
collettiva per affrontare il crescente carico globale di malattie croniche
Fonte: IFPMA
International Federation of Pharmaceutical Manufactures Association
Via libera della Commissione UE alla proposta di Regolamento
anti-carenze - Tra le misure nuove regole sule gare pubbliche, finanziamenti
alla produzione industriale e solidarietà tra gli Stati Membri sulle scorte. -
Collatina: «Ora i Governi europei lavorino con ambizione e rapidità sul piano
di implementazione di questa proposta»
Fonte: Egualia
Industrie Farmaci Accessibili
Commission proposes Critical
Medicines Act to bolster the supply of critical medicines in the EU
Fonte: Commissione
Europea
EFPIA response to the Critical
Medicines Act - EFPIA supports the European Commission’s ambition to strengthen
Europe’s medicines supply chain through the Critical Medicines Act.
Fonte: EFPIA
Pharmacokinetics and safety of
once-yearly lenacapavir:
a phase 1, open-label study
Fonte: The
Lancet
Enfortumab
Vedotin With or Without Pembrolizumab
in Metastatic Urothelial Carcinoma - A Systematic Review and Meta-Analysis
Fonte: Jama
Network
Sindrome di Alagille: maralixibat
è efficace e ben tollerato anche negli adolescenti - Il farmaco ha dimostrato
di poter migliorare il prurito colestatico e ridurre il livello degli acidi
biliari sierici
Fonte: OMAR
Osservatorio Malattie Rare
A model-based evaluation of the
pharmacokinetics-pharmacodynamics (PKPD) of avibactam
in combination with ceftazidime
- The emergence of β-lactamase-producing bacteria limits
the effectiveness of β-lactam (BL) antibiotics, and the
combination with a β-lactamase inhibitor (BLI) aims to
counteract this resistance. However, existing guidelines primarily focus on
optimizing the dosing of BLs and do not adequately address the interaction
between BLs and BLIs, leading to uncertain pharmacokinetic/pharmacodynamic
(PK/PD) targets and potentially suboptimal dosing strategies.
Fonte: JAC
Antimicrobial Resistance (Oxford Academic)
Dieta mediterranea: un alleato contro le malattie croniche
certificato dalle nuove linee guida
Fonte: Nutrienti e Supplementi
The environmental impact of
intravenous antimicrobial therapies: a comparison of OPAT and inpatient
administration care pathways
Fonte: JAC
Antimicrobial Resistance (Oxford Academic)
Protocol for COVID-19 vaccine
effectiveness multi-country study (VEBIS) using health data registries -
Version 3.0 - This protocol presents an updated common methodology for
estimating COVID-19 vaccine effectiveness (VE) using established health data
registries in participating European Union (EU) and European Economic Area
(EEA) Member States. This work is performed within the Vaccine Effectiveness,
Burden and Impact Studies (VEBIS) project. The first objective of the study is
to prospectively monitor COVID-19 VE via pooled estimates produced monthly as
part of a multi-country network. The present master protocol (version 3.0)
intends to update the methods previously used to monitor COVID-19 VE, adapting
them to the context of autumn 2024 vaccine campaigns in the EU/EEA.
Fonte: ECDC
European Centre for Disease Prevention and Control
Adjuvant Multiagent Chemotherapy
Regimens Associated with OS Benefit Following Resection of Localised Pancreatic
Adenocarcinoma Following Preoperative (m)FOLFIRINOX - Findings
from a retrospective cohort study
Fonte: ESMO European Society for Medical
Oncology
Parassitosi alimentari - Le parassitosi alimentari sono malattie
dell’uomo causate da parassiti trasmessi attraverso gli alimenti contaminati.
Fonte: ISSalute
(ISS Istituto Superiore di Sanita')
Le Aziende Farmaceutiche Informano
First Clinical Data for Gilead’s
Investigational Once-Yearly Lenacapavir
for HIV Prevention Presented at CROI 2025 and Published in The Lancet - Phase 1
Data Indicate Potential for Use of Once-Yearly Lenacapavir for HIV Prevention,
with Plans to Launch a Phase 3 Trial in 2H 2025 - Also at CROI: New PURPOSE 1
Data Showcasing Preference for Twice-Yearly Lenacapavir vs. Once-Daily Orals
and In-Depth Look at Adolescent Pharmacokinetic, Safety and Efficacy Data
Fonte: Gilead
ViiV Healthcare showcases leadership
in long-acting injectables innovation at CROI
2025 with data on third-generation integrase inhibitor (INSTI) and
highly potent capsid inhibitor against HIV-1 - Results illustrate ViiV
Healthcare’s pipeline is generating multiple options for the development of new
ultra long-acting HIV regimens - VH4524184 (VH184), a potent, investigational
third-generation integrase inhibitor (INSTI), demonstrates strong antiviral
activity and positive safety results across multiple dose levels in people with
HIV-1, supporting further development as a long-acting injectable
antiretroviral - VH4011499 (VH499), a promising, highly potent investigational
capsid inhibitor, shows positive antiviral activity and good safety findings
for treatment of HIV-1, supporting further development as a long-acting
antiretroviral
Fonte: GSK
MaaT Pharma Receives Positive
Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013
- Positive EMA Pediatric Committee opinion has cleared the investigation
clinical plan to evaluate the safety and efficacy of MaaT013 in patients from 6
years old to less than 18 years old with aGvHD - Key regulatory milestone
showing alignment with EMA expectations for pediatric investigation confirming
MaaT013 is on track towards a marketing authorization submission to the EMA in
June 2025 - MaaT013 has the potential to be the first microbiome-driven therapy
approved in Europe
Fonte: MaaT Pharma
Arvinas and Pfizer Announce Positive
Topline Results from Phase 3 VERITAC-2 Clinical Trial - VERITAC-2 achieved its
primary endpoint in the estrogen receptor 1-mutant population, demonstrating
statistically significant and clinically meaningful improvement in
progression-free survival - Vepdegestrant
is the first PROTAC degrader to demonstrate clinical benefit in a Phase 3 trial
Fonte: Pfizer
Sydnexis Announces FDA Acceptance of
New Drug Application for SYD-101
for the Treatment of Progression of Pediatric Myopia - FDA assigns a PDUFA
target action date of October 23, 2025 - If approved, SYD-101 would be the
first and only pharmaceutical treatment option proven to slow the progression
of pediatric myopia
Fonte: Sydnexis
Dispositivi
Medici (Avvisi di sicurezza)
Ministero
della Salute
ESAOTE
S.P.A. - US PROBE E 3-12
ZOLL
MEDICAL CORPORATION - POWERHEART G5 AED, SEMI-AUTOMATIC/ AUTOMATIC, G5X
MIM SOFTWARE INC. - MIM
MEDTRONIC
INC. - INCEPTIV RC APP PER TABLET DI PROGRAMMAZIONE CLINICA DELLA TERAPIA
IMTMEDICAL AG - EVAIR COMPRESSOR
FDA Food and Drug Administration
Smiths
Medical Issues Urgent Medical Device Correction Informing Customers of a
Potential Issue with Certain Sizes of Intubation ORAL/NASAL Endotracheal Tubes
Being Smaller Than Expected
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