#CHMP

@slidesource.bsky.social

1 day ago

Regulatory presentations require precision and expertise. SlideSource provides full support for FDA AdComms and CHMP meetings, and more. #RegulatoryExperts #PharmaSupport #FDA #CHMP

https://bit.ly/3zBBsIh

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pharmaphorum

@pharmaphorum.bsky.social

1 week ago

#Ipsen's #Ojemda is on course to become the first targeted medicine in the #EU for some #children with a form of #braincancer known as #lowgradeglioma, after it was recommended for approval by the #EMA's human medicines committee. #CHMP

pharmaphorum.com/news/chmp-ba...

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星良孝 Yoshitaka Hoshi

@yoshitakahoshi.bsky.social

1 month ago

UCB、TK2欠損症治療薬KYGEVVIがEMA CHMPで承認推奨──例外的状況下でEU販売承認へ前進 | STELLANEWS.LIFE STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見 | STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見

UCB、TK2欠損症治療薬KYGEVVIがEMA CHMPで承認推奨──例外的状況下でEU販売承認へ前進
KYGEVVI (doxecitine/doxribtimine) recommended for approval in the European Union for thymidine kinase 2 deficiency (TK2d)

stellanews.life/technology/8...

#TK2d #RareDisease #EMA #CHMP #UCB #ExceptionalCircumstances

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SlideSource

@slidesource.bsky.social

2 months ago

Regulatory presentations require precision and expertise. SlideSource provides full support for FDA AdComms and CHMP meetings, and more. #RegulatoryExperts #PharmaSupport #FDA #CHMP

https://bit.ly/3zBBsIh

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40:40 Recruitment - celia@4040recruitment.co.uk

@4040rec.bsky.social

2 months ago

CHMP decision levels the playing field for GSK's RSV jab GSK's RSV vaccine is poised for EU approval in all adults aged 18 and over, bringing it into line with rival shots from Pfizer and Moderna.

#vaccines #immunisations #CHMP #GSK #RSVvaccine #respiratorysyncytialvirus #respiratorysyncytialvirusvaccine #RSV #Arexvy #labelexpansion #CHMPrecommendation #Pfizer #Abrysvo #Moderna #mResvia #lowerrespiratorytractdisease #LRTD #RSVdisease #RSVinfections #infectiousdiseases
zurl.co/PkV03

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Don Porqué

@donporque.bsky.social

2 months ago

¿Qué es el Wegovy 7.2 mg y cómo actúa contra la obesidad? EMA respalda Wegovy 7,2 mg: pérdida media del 20,7% en 72 semanas y debate en España sobre financiación, acceso, seguridad y próximos pasos. La Agencia Europea de Medicamentos ha dado un paso decisivo...

¿Qué es el Wegovy 7.2 mg y cómo actúa contra la obesidad? #Wegovy #semaglutida #EMA #obesidad #pérdidadepeso #salud #AEMPS #CHMP #ComisiónEuropea #GLP1 #farmacoterapia #España #16dediciembre #felizmartes
donporque.com/que-es-el-we...

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INFARMED, I. P.

@infarmed-ip.bsky.social

3 months ago

Acordo sobre a reforma da legislação farmacêutica reforça acesso a medicamentos e competitividade do setor Infarmed

📍 Acordo sobre a reforma da legislação farmacêutica: reforçar acesso a medicamentos e competitividade do setor farmacêutico

Aceda à notícia na íntegra em:
🔗 swki.me/U6yNaMKt

#infarmed #CE #PE #UE #EMA #CHMP #PRAC

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SlideSource

@slidesource.bsky.social

3 months ago

Regulatory presentations require precision and expertise. SlideSource provides full support for FDA AdComms and CHMP meetings, and more. #RegulatoryExperts #PharmaSupport #FDA #CHMP

https://bit.ly/3zBBsIh

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Don Porqué

@donporque.bsky.social

4 months ago

¿Cómo actúa Teizeild y cuánto retrasa la diabetes tipo 1? La EMA respalda Teizeild (teplizumab), terapia que retrasa la diabetes tipo 1 hasta 50 meses. Qué cambia en Europa y el acceso real en la UE. La Agencia Europea de Medicamentos (EMA) ha emitido un dic...

¿Cómo actúa Teizeild y cuánto retrasa la diabetes tipo 1? #Teizeild #Teplizumab #DiabetesTipo1 #EMA #Salud #UE #España #Endocrinología #Inmunoterapia #DíaMundialDeLaDiabetes #14denoviembre #felizviernes #CHMP #FDA #MHRA donporque.com/como-actua-t...

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40:40 Recruitment - celia@4040recruitment.co.uk

@4040rec.bsky.social

4 months ago

CHMP backs first drug for lung disease bronchiectasis Insmed gets EU recommendation for first non-cystic fibrosis bronchiectasis therapy Brinsupri, and other CHMP decisions.

#bronchiectasis #respiratory #CHMP #Insmed #brensocatib #Brinsupri #noncysticfibrosisbronchiectasis #NCFB #ASPENtrial #Sanofi #Wayrilz #rilzabrutinib #immunethrombocytopenia #ITP #SanofiWinthrop #Rezurock #belumosudil #chronicgraftversushostdisease #GvHD #transplant #KadmonPharma
zurl.co/r27x2

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SlideSource

@slidesource.bsky.social

6 months ago

Regulatory presentations require precision and expertise. SlideSource provides full support for FDA AdComms and CHMP meetings, and more. #RegulatoryExperts #PharmaSupport #FDA #CHMP

https://bit.ly/3zBBsIh

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Profit Trading USA

@profittradingusa.bsky.social

7 months ago

Eli Lilly’s Alzheimer’s drug Kisunla gets positive CHMP opinion Investing.com -- Eli Lilly (NYSE:LLY)’s Alzheimer’s treatment Kisunla (donanemab) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending the drug for the treatment of early symptomatic Alzheimer’s disease. The European Commission is expected to make a final regulatory decision on donanemab in the coming months, following this recommendation. The CHMP based its positive opinion primarily on data from two clinical trials: TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6. These trials provided the evidence that supported the committee’s recommendation for approval. If approved by the European Commission, Kisunla would become available as a treatment option for patients with early symptomatic Alzheimer’s disease across European Union member states. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C. Don't miss out on the next big opportunity! Stay ahead of the curve with ProPicks – 6 model portfolios fueled by AI stock picks with a stellar performance this year.. In 2024 alone, ProPicks' AI identified 2 stocks that surged over 150%, 4 additional stocks that leaped over 30%, and 3 more that climbed over 25%. That's an impressive track record. With portfolios tailored for Dow stocks, S&P stocks, Tech Stocks, and Mid Cap stocks, you can explore various wealth-building strategies. So if LLY is on your watchlist, it could be very wise to know whether or not it made the ProPicks lists.

Click Subscribe #EliLilly #Alzheimers #Kisunla #CHMP #Pharmaceuticals

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Grupo de Trabajo sobre Tratamientos del VIH (gTt-VIH)

@gtt-vih.bsky.social

7 months ago

Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice Yearly Lenacapavir for HIV Prevention Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice Yearly Lenacapavir for HIV Prevention

El #CHMP (Comité de Medicamentos de Uso Humano) europeo ha dado su opinión positiva a lenacapavir como PrEP. ✅ Se espera que la decisión final de la Comisión Europea llegue este mismo 2025. 📅
www.gilead.com/news/news-de...

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Dr. McCoy 😷

@drmccoy.info

7 months ago

🧵1/x Dieser Punkt stand zwar nicht explizit auf der veröffentlichten Agenda für das aktuell laufende #CHMP Meeting der #EMA, aber aus diesem Kreis wurde nun die Zulassung des neu angepassten #BioNTech #Comirnaty #LP.8.1 empfohlen:

➡️ investors.biontech.de/de/news-rele...

(Weiter in 🧵2/x⤵️)

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European Medicines Agency

@ema.europa.eu

7 months ago

The agenda of EMA's human medicines committee #CHMP is now published.
Find out what medicines will be discussed this month 💊💉
www.ema.europa.eu/en/documents...
The committee highlights will be released on Friday.

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SlideSource

@slidesource.bsky.social

8 months ago

Regulatory presentations require precision and expertise. SlideSource provides full support for FDA AdComms and CHMP meetings, and more. #RegulatoryExperts #PharmaSupport #FDA #CHMP

https://bit.ly/3zBBsIh

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OncLive

@onclive.bsky.social

8 months ago

Subcutaneous Daratumumab Approaches EU Approval in High-Risk Smoldering Myeloma The EMA’s CHMP has issued a positive opinion regarding the use of subcutaneous daratumumab in high-risk smoldering myeloma.

Subcutaneous Daratumumab Approaches EU Approval in High-Risk Smoldering Myeloma #hematology #multiplemyeloma #CHMP
www.onclive.com/view/subcuta...

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OncLive

@onclive.bsky.social

8 months ago

Darolutamide Plus ADT Earns Positive Opinion for European Approval From CHMP in Metastatic Hormone-Sensitive Prostate Cancer The European Medicines Agency’s CHMP has recommended the approval of darolutamide plus ADT in mHSPC in the European Union.

Darolutamide Plus ADT Earns Positive Opinion for European Approval From CHMP in Metastatic Hormone-Sensitive Prostate Cancer #CHMP #prostatecancer #oncology

www.onclive.com/view/darolut...

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OncLive

@onclive.bsky.social

8 months ago

UM171 Cell Therapy Earns Positive CHMP Opinion for Hematological Malignancies The EMA’s CHMP has issued a positive opinion for UM171 cell therapy for patients with hematological malignancies and limited stem cell transplant options.

UM171 Cell Therapy Earns Positive CHMP Opinion for Hematological Malignancies #HematologyOncology #CHMP
www.onclive.com/view/um171-c...

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OncLive

@onclive.bsky.social

8 months ago

CHMP Recommends EU Approval of Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors The EMA’s CHMP has recommended the approval of cabozantinib for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

CHMP Recommends EU Approval of Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors #CHMP #oncology

www.onclive.com/view/chmp-re...

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OncLive

@onclive.bsky.social

8 months ago

Nirogacestat Awaits Review Following Positive CHMP Opinion for Desmoid Tumors The EMA’s Committee for Medicinal Products for Human Use granted a positive opinion for nirogacestat for the treatment of patients with desmoid tumors.

Nirogacestat Awaits Review Following Positive CHMP Opinion for Desmoid Tumors
#DesmoidTumors #CHMP
www.onclive.com/view/nirogac...

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Sadhna Bokhiria

@sbokhiria.bsky.social

8 months ago

‼️ Not every oncology drug gets a seat at the EU table.

👇 Get familiar with the 9 therapies driving change.

#Oncology #CHMP #EMA #DrugApprovals #Biotech

2 1 0 0

ilQuaderno.it

@ilquaderno.bsky.social

9 months ago

Patologie retiniche, Ema raccomanda aflibercept 8 mg fino a ogni 6 mesi (Adnkronos) - Nuove prospettive per i pazienti con patologie retiniche. Il Comitato per i medicinali per uso umano (Chmp) dell'Agenzia europea per i medicinali (Ema) ha espresso parere positivo per un'ulteriore estensione dell'intervall...

Patologie retiniche, Ema raccomanda aflibercept 8 mg fino a ogni 6 mesi ... LEGGI TUTTO #PatologieRetiniche #Aflibercept #Ema #Chmp #Salute

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INFARMED, I. P.

@infarmed-ip.bsky.social

9 months ago

CHMP recomenda alterações no uso da azitromicina para otimizar a sua utilização e combater a resistência antimicrobiana Infarmed

CHMP recomenda alterações no uso da azitromicina para otimizar a sua utilização e combater a resistência antimicrobiana

📰 swki.me/5BSqIQa8

#infarmed #CHMP #EMA #resistenciaantimicrobiana #azitromicina #medicamentos #saude

1 1 0 0

TRAstonDrs

@castltrastondrs.bsky.social

9 months ago

#Medsky🧪 #publichealth The Committee for Medicinal Products for #CHMP published the current list of Medicines in EU & needed to be discussed &
ETF recommends updating #COVID19vaccines & Therapeutic Tx to target new LP.8.1 variant

www.ema.europa.eu/en/search?se...

www.ema.europa.eu/en/documents...

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European Medicines Agency

@ema.europa.eu

9 months ago

The agenda of EMA's human medicines committee #CHMP is now published.

Find out what medicines will be discussed this month 💊💉
www.ema.europa.eu/en/events/co...

The committee highlights will be released on Friday.

18 1 0 1

40:40 Recruitment - celia@4040recruitment.co.uk

@4040rec.bsky.social

10 months ago

Argenx receives positive CHMP opinion for CIDP treatment - PharmaTimes VYVGART could be the first CIDP drug with a novel mechanism in 30 years

#Argenx #CHMP #CIDPtreatment #VYVGART #efgartigimodalfa #chronicinflammatorydemyelinatingpolyneuropathy #CIDPdrug #ADHEREtrial #CIDPclinicalstudy #IgGFcantibodyfragment #immunoglobulintherapy #CIPDpatients #EPODIN #CIPDmanagement #CHMPrecommendation #CHMPopinion
pharmatimes.com/news/argenx-...

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SlideSource

@slidesource.bsky.social

10 months ago

Regulatory presentations require precision and expertise. SlideSource provides full support for FDA AdComms and CHMP meetings, and more. #RegulatoryExperts #PharmaSupport #FDA #CHMP

https://bit.ly/3zBBsIh