Esempio di una circolare giornaliera
Novità
Sanitarie Farmaceutiche
FDA Food and Drug Administration
FDA Approves Drug for Adult and Pediatric Patients
Aged 6 and Older with Allergic Fungal Rhinosinusitis
On February 23, 2026, the U.S. Food
and Drug Administration (FDA) approved Dupixent (dupilumab) for the treatment
of adult and pediatric patients aged 6 years and older with allergic fungal
rhinosinusitis (AFRS) with a history of sino-nasal surgery or for whom surgery
is not advisable. This is the first approval for this condition.
Condition: Allergic fungal rhinosinusitis
(AFRS) is an uncommon type of chronic sinus inflammation caused by an allergic
reaction to fungi growing in the sinuses, with production of thick, sticky
mucus often described as resembling peanut butter. AFRS affects up to 8% of
people with chronic sinus inflammation and nasal polyps, is more common in
warm, humid areas where fungi thrive, and typically begins in teenagers and
young adults. If left untreated, AFRS can cause serious problems, including
expansion of the sinuses, erosion of surrounding bone (in up to 90% of
patients), and spread to the eye area or brain, leading to facial deformities,
vision problems, and nerve damage.
Data Supporting Dupixent: Dupilumab's effectiveness and safety
were evaluated in a 52-week study of adult and pediatric participants aged 6
years and older with AFRS. The study showed that dupilumab significantly improved
sinus opacification compared to placebo, as measured by CT scan scores
(Lund-Mackay score). Additional measures — including nasal polyp size, nasal
congestion, and sense of smell — also showed significant improvement and
supported the main findings.
Dupilumab substantially reduced the
need for systemic corticosteroids and sinus surgery compared to placebo over 52
weeks, which is particularly important given the severity of AFRS. The
medication also reduced sinus bone erosion, a serious complication unique to
AFRS. Together, these results demonstrate clear benefits across imaging
findings, endoscopic results, and patient-reported symptoms.
The safety profile of dupilumab in
AFRS patients is similar to what has been observed in patients with chronic rhinosinusitis
with nasal polyps, both in clinical trials and post-market setting. No safety
issues were identified that would outweigh the benefits of dupilumab.
For children and adolescents aged 6
to <18 years, the effectiveness of dupilumab is based on adult AFRS data,
supported by the fact that the disease works similarly across age groups and
that children achieve comparable drug levels at weight-adjusted doses. Safety
data comes from supportive results in children and adolescents treated for
other conditions.
Based on the trial results and the
existing safety database for dupilumab's approved uses, the benefits outweigh
the risks for treating AFRS in patients 6 years and older.
Safety Information: The most common side effects of
Dupixent are injection-site reactions, eosinophilia (elevated count of white
blood cells), insomnia, toothache, gastritis, and joint pain.
Designation: Dupixent received priority review
designation for this indication.
SPS - Specialist
Pharmacy Service (NHS)
Introduction
to advanced therapy medicinal products (ATMPs)
ATMPs are biological medicines that
use cells, genes or tissues to treat complex conditions including cancers, rare
diseases and genetic disorders.
Types of ATMPs
ATMPs represent a rapidly evolving
area of modern medicine and require robust governance, specialist handling and
multidisciplinary collaboration. These innovative medicines fall into three
main categories:
Gene therapy medicinal products
Somatic cell therapy medicinal products
Tissue engineered products
SPS - Specialist
Pharmacy Service (NHS)
Outsourcing
marketed ATMPs: A template technical agreement
11
February 2026 · A template Quality Technical Agreement for
outsourcing the receipt, storage, preparation and onward supply of marketed
cryopreserved ATMPs.
Outsourcing
ATIMP storage or preparation across legal boundaries
11 February 2026 · Guidance on the
considerations for pharmacy clinical trial sites outsourcing activities
involved in the delivery of ATIMPs.
Requirements
for governance and preparation of gene therapy
11 February 2026 · Practical advice
for centres implementing gene therapies detailing governance requirements and
optimal preparation location decision making support.
Managing
the risks of using effervescent tablets in children
11 February 2026 · Careful use of
effervescent or soluble tablets to deliver part tablet doses for children and
neonates can minimise risks of toxicity or suboptimal therapy
Performing
preparation risk assessments for ATMPs
11 February 2026 · Preparation risk
assessment tools for cell and tissue-based advanced therapy medicinal products
(ATMPs) and in-vivo gene therapies.
Pharmacy
oversight and supervision when preparing cellular ATMPs
11 February 2026 · This guidance
provides definitions of oversight and supervision and clarifies where each are
required when implementing ATMPs.
SPS - Specialist
Pharmacy Service (NHS)
Identifying
risk factors for developing a long QT interval
17 February 2026 · Some medicines (erythromycin,
citalopram,
ondansetron)
can cause a long QT interval. Consider risk factors and follow MHRA
recommendations for safe use
NICE National Institute for Health and
Care Excellence
More
than 20,000 people benefitting from innovative migraine pills recommended by
NICE
A new type of tablet specifically designed to prevent
migraine is transforming lives across England, with the number of people being
prescribed these medicines more than tripling in just one year.
NICE’s approval of the therapies has
given people with migraine further treatment choice. Joanne McShane, an NHS
health visitor, had suffered from migraine for a decade when she was first
prescribed atogepant in 2024, shortly after NICE recommended the new treatment
option. “It is life changing,” she said. “I thought ‘this is going to be
another thing that works for a little while and then stops’. But I haven't had
a headache since. It has restored my life.” In 2025, 22,800 people were
prescribed atogepant or rimegepant by their GPs – more than triple the number
in 2024 – following NICE approval of the treatments. The total receiving these
tablets across the NHS is higher still, as these figures exclude prescriptions
from hospitals and specialist clinics. Nice's approval of these new tablets has
widened access for those whom other preventive therapies had failed.
AIFA -
Nuovi Farmaci e Confezioni Autorizzati in Italia
Elenco dei nuovi
farmaci e confezioni autorizzati
dall’AIFA Agenzia Italiana del Farmaco
e Pubblicati nella Gazzetta Ufficiale
del 25 febbraio 2026. Ogni link Vi porta al testo completo della Determina o Comunicato AIFA
etofenamato,
Etofenamato Greencango
sacubitril,
valsartan, Sacubitril e Valsartan KRKA
amiodarone
cloridrato, Amiodarone DOC
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 – Refused - Withdraw):
Triheptanoin
- Treatment of carnitine palmitoyltransferase II deficiency
Triheptanoin
- Treatment of mitochondrial trifunctional protein deficiency
Triheptanoin
- Treatment of long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency
Triheptanoin
- Treatment of very long-chain acyl-CoA dehydrogenase deficiency
MHRA Medicines and Healthcare products
Regulatory Agency
Orphan
registered medicinal products
A list of authorised orphan
medicinal products registered by the UK licensing authority.
Last updated: 25 February 2026
Addition
of an Orphan designation for Minjuvi
EMA Agenzia Europea per I Medicinali
Paediatric Investigation Plan (Aggiornamento del 25
febbraio 2026)
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.
2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione
- Congenital, familial and genetic disorders
iodine (131I) apamistamab - Surgical and medical procedures
vatiquinone
- Neurology
naldemedine
tosilate - Gastrointestinal disorders
abelacimab
- Vascular disorders
Commissione
Europea
Selezione
delle novita’ sui medicinali uso umano pubblicate sul sito web della CE
Nuove Autorizzazioni -
Modifiche e Comunicazioni pubblicate sui seguenti medicinali:
Balversa
(erdafitinib)
Deltyba
(delamanid)
Evkeeza
(evinacumab)
Flucelvax
Tetra (influenza vaccine)
Rybrevant
(amivantamab)
Takhzyro
(lanadelumab)
Vectibix
(panitumumab)
Vokanamet
(canagliflozin – metformina)
Wilzin
(zinc acetate dihydrate)
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:
Byooviz
(ranibizumab)
CellCept
(micofenolato mofetil)
DaTSCAN
(ioflupane 123I)
Daxas (roflumilast)
Eltrombopag (Accord)
Gotenfia (golimumab)
Hepcludex (bulevirtide)
Kavigale
(sipavibart)
Qaialdo
(spironolactone)
Sprycel
(dasatinib)
Steqeyma
(ustekinumab)
Sycrest
(asenapine)
Tibsovo
(ivosedinib)
Verzenios
(abemaciclib)
FDA
Food and Drug Administration
Pubblicazioni delle nuove autorizzazioni
all’immissione in commercio (Orig-1) dei seguenti farmaci:
SITAGLIPTIN
PHOSPHATE (AJANTA PHARMA) - Tentative Approval
LIRAGLUTIDE (BIOCON PHARMA)
LIRAGLUTIDE (ORBICULAR)
MICAFUNGIN
SODIUM (YICHANG HUMANWELL)
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
depemokimab (TBC)
Mirvetuximab
Soravtansine (Elahere)
Ferric
Derisomaltose for Heart Failure and Iron Deficiency
CDA-AMC
Canada’s Drug Agency - L’Agence des Medicaments du Canada
Ferric
derisomaltose for heart failure
Project Status: Completed
Project Sub Line: Rapid Review
What Is the Issue?
Iron deficiency is a common
comorbidity in patients with heart failure. -
Decision-makers are interested in understanding the clinical efficacy
and safety of ferric derisomaltose in the treatment of patients with heart
failure and iron deficiency.
What Did We Do?
We searched key resources, including
journal citation databases, and conducted a focused internet search for
relevant evidence published since 2020
EMA
Agenzia Europea per i Medicinali
List
of medicines under additional monitoring - Aggiornamento
del 25 febbraio 2026
L'elenco dei medicinali sottoposti a
monitoraggio addizionale include medicinali autorizzati nell'Unione Europea (UE)
che vengono monitorati in modo particolarmente attento dalle autorità di
regolamentazione. I medicinali sottoposti a monitoraggio addizionale hanno un
triangolo nero capovolto visualizzato nel foglio illustrativo e nel riassunto
delle caratteristiche del prodotto, insieme a una breve frase che spiega cosa
significa il triangolo.
Summary of changes in February 2026
The following CAPs have been added to the list:
Ranluspec
- New biological
Gotenfia
- New biological
Myqorzo
- New active substance
mNexspike
- New biological, new active substance
Exdensur
- New biological, new active substance
Aumseqa
- New active substance
The following CAPs have been removed from the list:
Lydisilka
- Five years following its authorisation (June 2021)
Yuflyma
- Five years following its authorisation (March 2021)
Insulin
aspart Sanofi - Five years following its authorisation (July 2020)
Enspryng
- Five years following its authorisation (July 2021)
Orladeyo
- Five years following its authorisation (May 2021)
Ministero
della Salute
-) Rappresentanza
Assemblea generale dell’Alleanza, Comitato Esecutivo
-) Elenco
delle Società/Associazioni aderenti all'Alleanza cardio- cerebrovascolare 2026
-) Regolamento
dell’Alleanza italiana per le malattie cardio-cerebrovascolari 2026
FarmacoVigilanza
MHRA Medicines and Healthcare products
Regulatory Agency
Medicines:
Marketing Authorisation Holders' submission of Nitrosamine risk evaluation,
risk assessment and confirmatory testing
Marketing Authorisation Holders
should review their manufacturing processes to mitigate the risk of nitrosamine
impurities being present. - In accordance with the CHMP opinion under Article 5
(3) of Regulation (EC) No. 726/2004 on the presence of nitrosamine impurities
in human medicinal products, as a precaution, marketing authorisation holders
(MAHs) should review their manufacturing processes to mitigate the risk of
nitrosamine impurities being present. MAHs should work with manufacturers of
API and finished products in order to review the API and finished product
manufacturing processes in light of the arrangements for preventing nitrosamine
formation as well as contamination or cross-contamination. This should take
into account their knowledge of the manufacturing processes as well as the
potential sources of nitrosamine impurities. Update February 2026: MAHs are
reminded of their responsibilities to monitor and mitigate nitrosamine risks
throughout the lifecycle of their products.
MHRA Medicines and Healthcare products
Regulatory Agency
MHRA
disrupts second manufacturing facility suspected to be involved in the manufacture
of illegal weight loss medicines in latest blow to criminal network - Officers from the MHRA's Criminal
Enforcement Unit (CEU) have raided two separate premises as part of an ongoing
investigation into an organised criminal network involved in the manufacture
and sale of unlicensed weight loss medicines.
Carenza Farmaci
AIFA
Agenzia Italiana dcel Farmaco
Carenza
VANFLYTA (quizartinib) - modalità di richiesta d'importazione dall'estero
L'Agenzia Italiana del Farmaco rende disponibili
aggiornamenti relativi al medicinale "VANFLYTA (quizartinib) 17,7 mg -
Compressa rivestita con film - Uso orale blister (alluminio/alluminio) - 28 × 1
compresse (dose unitaria) (A.I.C.050967025)”, non reperibile sul territorio
nazionale per il quale è stata autorizzata l’importazione dall’estero su
richiesta dell’azienda.
AIFA
Agenzia Italiana dcel Farmaco
Carenza
CAELYX PEGYLATED LIPOSOMAL - modalità di richiesta d'importazione dall'estero
L'Agenzia Italiana del Farmaco rende disponibili
aggiornamenti relativi al medicinale “CAELYX PEGYLATED LIPOSOMAL (doxorubicina
cloridrato) 2 mg/ml concentrato per soluzione per infusione - 1
flaconcino 10 ml uso EV (A.I.C. 033308014)”, non reperibile sul territorio
nazionale per il quale è stata autorizzata l’importazione dall’estero del
medicinale "DOXIL" su richiesta dell’azienda
AIFA
Agenzia Italiana dcel Farmaco
Carenza
TEMOMEDAC (temozolomide) 20 MG - modalità di richiesta d'importazione
dall'estero
L'Agenzia Italiana del Farmaco rende disponibili
aggiornamenti relativi al medicinale “TEMOMEDAC (temozolomide) 20 mg - capsula
rigida - uso orale - flacone (vetro) 5 capsule (A.I.C. 042082038)”, non
reperibile sul territorio nazionale per il quale è stata autorizzata
l’importazione dall’estero su richiesta dell’azienda.
AIFA
Agenzia Italiana dcel Farmaco
Carenza
GASTROMIRO (iopamidolo) - modalità di richiesta d'importazione dall'estero
L'Agenzia Italiana del Farmaco rende disponibili
aggiornamenti relativi al medicinale "GASTROMIRO (iopamidolo) 61,2%
soluzione - flacone 100 ml per uso orale o rettale (A.I.C. 026899031)”, non
reperibile sul territorio nazionale per il quale è stata autorizzata
l’importazione dall’estero su richiesta dell’azienda.
Giurisprudenza
Sanitaria Farmaceutica
Corte
di Cassazione (Sentenza del 19 febbraio 2026 n.6857)
Certificazione
Medica
La Suprema Corte ha affermato che non può attribuirsi minore
capacità rappresentativa a una certificazione medica resa al di fuori del
servizio sanitario nazionale (Ssn); in particolare, non è privo di validità ai
fini della prognosi il certificato del medico privato che opera in regime
libero professionale, successivo al primo rilasciato dal medico del Ssn, anche
in assenza di effettuazione di esami strumentali. Autore: Chiara di Lorenzo - Ufficio Legislativo FNOMCeO
Rassegna
Sanitaria Farmaceutica
ASCO American Heart Association
Intravenous Amiodarone
in Preexcited Atrial Fibrillation: A Systematic Review
ASCO American Society of Clinical
Oncology
Cost-Effectiveness of Dabrafenib Plus Trametinib
Versus Standard Chemotherapy in BRAFV600E-Mutant Pediatric Low-Grade Glioma
BMJ Journals of Hospital Pharmacy
Assessment
of residual stainless steel surface contamination in an anticancer drug
preparation microbiological safety cabinet after decontamination with four
cleaning solutions
British Journal of Clinical Pharmacology
Lean body weight should guide enoxaparin
dosing in obesity: A response to Roberts et al
ESMO European Society for Medical
Oncology
FDA Approves Pembrolizumab
with Paclitaxel
for Platinum-Resistant
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma - It also
approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic device
Gimbe
Scienza per
decidere. Salute da proteggere. Sanità pubblica da difendere. GIMBE
compie 30 anni: il 4 marzo al via il programma annuale con uno streaming sul
futuro del SSN e i nuovi dati sulla mobilità sanitaria - Nel 2026 GIMBE compie
trent’anni. Dal 1996 promuove l’integrazione delle migliori evidenze
scientifiche in tutte le decisioni che riguardano la salute delle persone. Dal
2013, con la campagna #SalviamoSSN, monitora l’evoluzione del Servizio
Sanitario Nazionale e difende il diritto costituzionale alla tutela della
salute. Sempre nel segno dell’indipendenza e del rigore metodologico.
Istituto
di Ricerche Farmacologiche Mario Negri IRCCS
Malattie
renali rare: da un’unica diagnosi emergono cinque profili, verso terapie sempre
più mirate - Il lavoro del Mario Negri su una forma ultra rara di danno
renale. Allo studio un’app per orientare diagnosi e scelta terapeutica
JAC
Antimicrobial Resistance (Oxford Academic)
The
AMR footprint: an integrative indicator in the global response to antimicrobial
resistance
The Lancet
Fixed-dose daily doravirine
(100 mg) with islatravir
(0·25 mg) versus bictegravir,
emtricitabine,
and tenofovir
alafenamide for initial HIV-1 therapy: 48-week results of a phase 3,
randomised, controlled, double-blind, non-inferiority trial
Dispositivi
Medici (Avvisi di sicurezza nazionali ed internazionali)
FDA Food and Drug Administration
Early
Alert: Heart Pump Purge Cassette Issue from Abiomed
CDRH is issuing this Early Alert to
notify the public 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.
Ministero della Salute
ZHERMACK S.P.A. - 60578320 AQUASIL
PUTTY SOFT REG PACK 2X450ML 60578321AQUASIL PUTTY SOFT PACK4X(450+450ML)
60578332 AQUASIL PUTTY HARD FAST PACK 2X450ML 60578333 AQUASIL PUTTY HARD
PACK4X(450+450ML)
Le
Aziende Farmaceutiche Informano
Argo
Biopharma
Argo Biopharma to Present Positive
Phase II Interim Results of siRNA Therapeutic BW-20805 for HAE
at the 2026 AAAAI Annual Meeting - Poster Presentation Selected as Late
Breaking Abstract - Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a
clinical-stage small interfering RNA (siRNA) therapeutics company, has been
selected as a late breaking abstract to present Phase II interim data for
BW-20805 during the American Academy of Allergy, Asthma & Immunology
(AAAAI) 2026 Annual Meeting on February 27-March 2, 2026
Azafaros
Azafaros Announces Publication
of Preclinical Efficacy Data with Nizubaglustat
in GM2 Gangliosidosis - Preclinical proof-of-concept data in GM2 gangliosidosis
demonstrated survival benefit, functional improvement and target engagement -
Results are published in the 7 January issue of the Journal of Inherited
Metabolic Disease - Nizubaglustat is currently in Phase 3 registrational
studies in GM1/GM2 gangliosidoses and Niemann-Pick type C disease (NPC)
Cumberland Pharmaceuticals
Cumberland
Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused
on developing new products for rare diseases, today announced the launch of its
national sales promotional for Talicia.
Cumberland has assumed responsibility for the distribution and sales promotion
of the brand in the U.S. under the co-commercialization agreement with RedHill
Biopharma. Talicia is an FDA-approved oral capsule indicated for the treatment
of Helicobacter pylori infection in adults, a bacterial infection and leading
risk factor for gastric cancer. Talicia is the only all-in-one treatment
containing omeprazole,
amoxicillin
and
rifabutin and is now listed as a first-line option in the American
College of Gastroenterology guidelines for H. pylori infections. Talicia is
patent protected through 2042 and received eight years of U.S. market
exclusivity under its Qualified Infectious Disease Product designation.
Ethris
Ethris
Part of Consortium to Receive up to EUR 148 Million European Commission
Contract to Advance Novel Pandemic Influenza Vaccine - Initial tender
contract of EUR 13 million supports gated advancement into two subsequent
competitive phases - Ethris GmbH, a
clinical-stage biotechnology company pioneering next-generation RNA
therapeutics and vaccines, today announced that the European Health and Digital
Executive Agency (HaDEA) has awarded an initial EUR 13 million under a tender
contract worth up to EUR 148 million to NOFLU, a vaccine development consortium
comprising Ethris and six other European partners. The funding will support the
advancement of Ethris’s mRNA vaccine technology as a mucosal vaccine against
pandemic influenza. NOFLU is one of just three programs funded under this competitive
pre-commercial procurement framework as part of a broader EU initiative to
explore multiple vaccine strategies in parallel.
GSK
ViiV Healthcare presents pipeline
data for two investigational HIV treatment therapies with potential for
twice-yearly dosing - VH184,
the first, third‑generation integrase inhibitor in development shows
potential for up to twice-yearly dosing intervals - Additional in-vitro data on
VH184 demonstrate improved potency and an enhanced resistance profile versus
bictegravir - VH499 demonstrates good tolerability, supporting twice-yearly
dosing intervals
GSK
ViiV Healthcare reports positive
12-month data showing investigational bNAb
lotivibart (N6LS) maintains high levels of viral suppression in
long-acting HIV treatment regimen - 94% of adults on stable therapy maintained
viral suppression with intravenous lotivibart dosed every four months in
combination with long-acting cabotegravir - These phase IIb results reinforce
lotivibart’s ultra long-acting potential, with the trial progressing to
evaluate a twice-yearly intravenous dosing interval
Hikma
Hikma launches
authorised generic of
Nucynta (tapentadol)
in the US - Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary
Hikma Pharmaceuticals USA Inc. (Hikma), announces it has launched an authorised
generic version of Nucynta® (tapentadol) for US patients.
Ideaya
IDEAYA Biosciences Announces
First-Patient-In for Phase 1 Trial of IDE034,
a Potential First-In-Class
B7H3/PTK7 Bispecific TOP1 ADC - Phase 1 dose escalation trial to
determine safety, tolerability and PK of IDE034 - Potential as a monotherapy
and in combination with proprietary PARG inhibitor,
IDE161 - B7H3/PTK7 co-expressed in 30-40% of multiple solid tumor
types, including lung, breast, ovarian and colorectal cancers
InnoCare Pharma
InnoCare
Announces Key Developments of Critical Clinical Studies - InnoCare
Pharma (HKEX:
09969), a leading biopharmaceutical company focusing on the treatment
of cancer and autoimmune diseases, announced today key clinical development
progress, including the completion of patient enrollment of multiple Phase III
registrational trials. - The Company completed patient enrollment of a Phase
III registrational clinical trial of BCL2
inhibitor mesutoclax
(ICP-248)
in combination with BTK inhibitor orelabrutinib
for treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL) patients.
Lupin
Lupin Announces the
Approval and Launch of Brivaracetam
Oral Solution in the United States - Global pharma major Lupin Limited (Lupin)
today announced that it has received approval from the U.S. FDA for its
Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10
mg/mL. Brivaracetam is the bioequivalent to Briviact
Oral Solution, 10 mg/mL, of UCB, Inc. and is indicated for the treatment of
partial-onset seizures in patients 1 month of age and older. Following the
approval, the company initiated the launch of Brivaracetam Oral Solution in the
United States.
Merck
Merck Announces Late-Breaking Data
from Three Phase 3 Trials Evaluating Doravirine
/
Islatravir (DOR/ISL),
an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults
Living with HIV-1 at CROI 2026 - DOR/ISL
is the first non-INSTI, two-drug regimen to demonstrate non-inferiority and a
similar safety profile at Week 48 to BIC/FTC/TAF
in adults living with HIV-1 who had not previously received antiretroviral
treatment -
DOR/ISL maintained virologic
suppression at Week 96 in adults with virologically suppressed HIV-1 who
switched from other oral antiretroviral therapies, including BIC/FTC/TAF
Novartis
Novartis
to build new radioligand therapy site in Denton, Texas, delivering more next-generation
treatments to patients - Facility expected to be operational in 2028 in
Dallas-Fort Worth area, expanding largest RLT manufacturing network in US -
Site to serve patients in Southern US and add network capacity as RLT expands
into earlier treatment lines and additional tumor types - Company broke ground
on 4 new manufacturing and R&D facilities, initiated 3 facility expansions,
and announced 2 additional sites in last 10 months, rapidly making progress on
its commitment to expand its US operations
Novo Nordisk
Novo
Nordisk and Vivtex partner to develop next-generation oral medicines for
obesity and diabetes - Partnership will leverage Vivtex’s proprietary
technologies built to identify optimal oral formulations for peptide and
protein therapeutics with improved bioavailability - Novo Nordisk will lead
global development and commercialization, and Vivtex is eligible to receive up
to 2.1 billion US dollars, as well as royalties on net sales of future products
- Partnership expands Vivtex’s platform to metabolic diseases and supports Novo
Nordisk’s mission to deliver scalable and innovative medicines to people with
obesity and diabetes
Viatris
FDA Accepts Viatris
Supplemental New Drug Application for MR-141 (Phentolamine
Ophthalmic Solution 0.75%) for the Treatment of Presbyopia - Viatris
Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S.
Food and Drug Administration (FDA) has accepted for review the supplemental New
Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for
the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October
17, 2026. Presbyopia is the age-related progressive loss of the ability to
focus on close objects that results in blurred near vision and eye strain. The
condition affects approximately 90% of adults in the U.S. over the age of 45.
Ydeaya
IDEAYA Biosciences
Announces First-Patient-In for Phase 1 Trial of IDE034,
a Potential First-In-Class B7H3/PTK7 Bispecific TOP1 ADC - Phase 1 dose
escalation trial to determine safety, tolerability and PK of IDE034 - Potential
as a monotherapy and in combination with proprietary PARG inhibitor,
IDE161 - B7H3/PTK7
co-expressed in 30-40% of multiple solid tumor types, including lung, breast,
ovarian and colorectal cancers
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