#CHMP-Meeting
LightNews LightNews
meducationai.bsky.social
CHMP backed extending teclistamab to R/R myeloma after at least 1 prior therapy, not 3 (meeting of Sept 14 to 17).

MajesTEC-9: median PFS not reached vs 8.2 months, HR 0.29; OS HR 0.60. A committee opinion, not an EU authorisation yet.

#HemOnc
September 26, 2026 at 8:16 PM
europepharmatoday.bsky.social
CHMP recommended 12 medicines and 11 extensions. Opinions, not EU MAs.

https://europepharmatoday.com/news/chmp-september-2026-meeting-highlights?utm_source=bluesky&utm_medium=social&utm_campaign=chmp-september-2026-meeting-highlights
#CHMP
Friday CHMP desk: 12 medicines recommended. Zero EU marketing authorisations. 11 extensions; Xervyteg refusal confirmed.
September 18, 2026 at 2:40 PM
europepharmatoday.bsky.social
CHMP agenda ≠ outcomes. EMA’s 14–17 Sep list is a work list — opinions land Friday.

https://europepharmatoday.com/news/chmp-september-2026-meeting-agenda-week-watch?utm_source=bluesky&utm_medium=social&utm_campaign=chmp-september-2026-meeting-agenda-week-watch
#CHMP
CHMP pathway myth-buster: agenda and opinion are not marketing authorisation
September 15, 2026 at 5:58 AM
drmccoy.info
mNexspike war auch Thema beim "Juli CHMP Meeting":

bsky.app/profile/drmc...

⤵️
drmccoy.info Dr. McCoy 😷 @drmccoy.info · Jul 21
Update: Auf dem aktuellen #CHMP Meeting der #EMA (siehe Agenda-PDF, S. 28 u. 29):

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

...werden alle 5 wichtigen #Impfstoffe zu #Covid19 thematisiert:

1) Comirnaty mRNA
2) mCOMBRIAX (Influenza + Covid19, mRNA)
3) mNEXSPIKE mRNA
4) Nuvaxovid (Protein)
5) Spikevax mRNA
August 3, 2026 at 10:08 PM
europepharmatoday.bsky.social
CHMP opinions from 20–23 July are out — 12 positives, 3 negatives. Commission MAs still pending.
https://europepharmatoday.com/news/chmp-july-2026-meeting-highlights?utm_source=bluesky&utm_medium=social&utm_campaign=chmp-july-2026-meeting-highlights
#CHMP #EMA
July 27, 2026 at 5:58 AM
drmccoy.info
Die untenstehende, berechtigte Fragestellung zu #Novavax #Nuvaxovid #XFG lässt sich heute mit Erscheinen der Juli #CHMP Meeting Highlights im positiven Sinne beantworten:

Ja, endlich ist mal mit einer früheren Nuvaxovid-Verfügbarkeit als i.d. letzten Jahren zu rechnen:

➡️ bsky.app/profile/drmc...
hwiesenmueller.bsky.social Heidrun Wiesenmüller @hwiesenmueller.bsky.social · Jul 16
Gibt's schon einen Hinweis, wann der neue Nuvaxovid-Impfstoff zu erwarten ist? Wäre ja schön, wenn er mal etwas früher im Jahr käme.
July 24, 2026 at 11:02 AM
europepharmatoday.bsky.social
CHMP July: 12 new medicine opinions + 8 extensions. Opinions ≠ EU MAs.

https://europepharmatoday.com/news/chmp-july-2026-meeting-highlights?utm_source=bluesky&utm_medium=social&utm_campaign=chmp-july-2026-meeting-highlights
July 24, 2026 at 11:01 AM
ema.europa.eu
📢 EMA recommends: 12 new medicines for approval, including one medicine for plaque psoriasis. Read more here:
🔗 www.ema.europa.eu/en/news/meet...

🧪 #PublicHealth #medsky #SciComm
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026 | European Medicines Agency (EMA)
Twelve new medicines recommended for approval; another eight medicines recommended for extension of their therapeutic indications
www.ema.europa.eu
July 24, 2026 at 10:51 AM
drmccoy.info
⚠️ Wichtiges Update: Die #CHMP Meeting Highlights der #EMA (vom 20.-23.07.) sind da! Mit guten Nachrichten für alle wichtigen #Impfstoffe mit Anpassung auf #XFG gegen #Covid19 #impfxfg:

www.ema.europa.eu/en/news/meet...

Alle wurden dieses Mal frühzeitig zur Zulassung empfohlen (Screen + Alt-Text)!⬇️
Other updates The CHMP gave a positive opinion to update the composition of the vaccines Bimervax, Comirnaty, Nuvaxovid and Spikevax to target the new XFG variant of the virus that causes COVID-19. The revision of these vaccines is in line with the recommendation issued by EMA’s Emergency Task Force for the 2026/2027 vaccination campaign.
July 24, 2026 at 10:41 AM
drmccoy.info
Update: Auf dem aktuellen #CHMP Meeting der #EMA (siehe Agenda-PDF, S. 28 u. 29):

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

...werden alle 5 wichtigen #Impfstoffe zu #Covid19 thematisiert:

1) Comirnaty mRNA
2) mCOMBRIAX (Influenza + Covid19, mRNA)
3) mNEXSPIKE mRNA
4) Nuvaxovid (Protein)
5) Spikevax mRNA
9.1.2. Comirnaty - COVID-19 mRNA vaccine - EMA/VR/0000355113 BioNTech Manufacturing GmbH Rapporteur: Filip Josephson Scope: Quality variation Action: For adoption 9.1.10. mCOMBRIAX - Influenza and COVID 19, mRNA vaccine - EMA/VR/0000347770 Moderna Biotech Spain S.L. Rapporteur: Daniela Philadelphy Scope: Quality variations Action: For adoption 9.1.11. mNEXSPIKE - COVID-19 mRNA vaccine - EMA/VR/0000333455 Moderna Biotech Spain S.L. Rapporteur: Jan Mueller-Berghaus Scope: Quality variations Action: For adoption 9.1.13. Nuvaxovid - COVID-19 vaccine (recombinant, adjuvanted) - EMA/VR/0000356615 Sanofi Winthrop Industrie Rapporteur: Patrick Vrijlandt Scope: Quality variation Action: For adoption 9.1.14. Spikevax - COVID-19 mRNA vaccine - EMA/VR/0000356879 Moderna Biotech Spain S.L. Rapporteur: Jan Mueller-Berghaus Scope: Quality variation Action: For adoption
July 21, 2026 at 8:35 AM
europepharmatoday.bsky.social
CHMP week: agenda ≠ approval. Opinion ≠ Commission MA.

https://europepharmatoday.com/news/chmp-july-2026-meeting-agenda-week-watch?utm_source=bluesky&utm_medium=social&utm_campaign=chmp-july-2026-meeting-agenda-week-watch
July 21, 2026 at 5:48 AM
drmccoy.info
#impfxfg Vorab-Info:

Vom 20. bis 23.07. findet das nächste CHMP Meeting der EMA statt.

Möglicherweise gibt es im Zuge dessen bereits eine Zulassung des neuen variantenangepassten #Covid19 Impfstoffes #BioNTech #Comirnaty #XFG.

Halten wir also ein Auge drauf.

➡️ www.ema.europa.eu/en/events/co...
Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2026 | European Medicines Agency (EMA)
www.ema.europa.eu
July 15, 2026 at 3:35 PM
drmccoy.info
Wahrscheinlich wird es der "XFG", wobei die WHO auch noch den (alten) LP.8.1 aus der Vorsaison als Empfehlung genannt hatte.

Da jedoch für unsere Breiten die Europäische Arzneimittelagentur den #XFG empfohlen hat, gehe ich von diesem aus.

Wird möglicherweise bereits beim nächsten #CHMP Meeting⤵️
July 4, 2026 at 1:37 PM
drmccoy.info
Ja, im Moment ist es dort noch der bisherige LP.8.1, aber sie haben, sobald verfügbar, dort immer recht schnell auch den neuen zur Hand. Möglicherweise ab etwa September, wenn jetzt im Juli noch bei CHMP-Meeting die Zulassung erfolgt.
July 4, 2026 at 1:35 PM
drmccoy.info
1/2⤵️ Dem schließe ich mich an. Ich halte es für wahrscheinl., dass wir ab dem kommenden #CHMP Meeting der #EMA, das in diesem Jahr vom 20. bis 23. Juli (www.ema.europa.eu/en/events/co...) stattfinden wird, mehr wissen werden.

Im vergangenen Jahr war es auch dieser Zeitraum:
bsky.app/profile/drmc...
July 4, 2026 at 11:39 AM
vitalsignsnews.bsky.social
EMA recommends three new medicines and an orphan treatment for rare Rett Syndrome
#CHMP #EMA #Pharmaceuticals #CSLSeqirus #Parkinsons #RettSyndrome
www.vitalsigns.news/ema-recommen...
EMA recommends three new medicines and an orphan treatment for rare Rett Syndrome
EMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting
www.vitalsigns.news
June 29, 2026 at 11:56 AM
l2plabs.bsky.social
Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy
The positive opinion is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, previously presented at the 2025 American Society of Hematology Annual Meeting and published in The Journal of Clinical Oncology BRUIN CLL-313 is the first Phase 3 study to evaluate a...
dlvr.it
June 26, 2026 at 11:20 AM
pharmaphorum.bsky.social
Following the Bank Holiday, catch up on:

In a packed programme, the #EMA's human medicines committee recommended eight #newmedicines and 13 line extensions at its May meeting, including #NovoNordisk's oral formulation of #GLP1 agonist Wegovy for weight loss. #CHMP

pharmaphorum.com/news/oral-we...
Oral Wegovy backed by CHMP at May meeting
The CHMP recommended eight new medicines and 13 line extensions at its May meeting, including Novo Nordisk's oral weight loss therapy.
pharmaphorum.com
May 26, 2026 at 9:14 AM
ema.europa.eu
📢 We just recommended 5 new medicines for approval, including a medicine for extensive-stage small cell lung cancer, with currently has very limited treatment options

Find out more in our highlights🔗 www.ema.europa.eu/en/news/meet...

#PublicHealth #medsky 🧪
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026 | European Medicines Agency (EMA)
Five new medicines recommended for approval; another 13 medicines recommended for extension of their therapeutic indications
www.ema.europa.eu
March 27, 2026 at 11:59 AM
franzhefter.bsky.social
EMA's human medicines committee, the CHMP, recommended for approval in the EU:
☑️ The first combined messenger RNA vaccine against COVID-19 and seasonal influenza (flu)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026 | European Medicines Agency (EMA)
12 new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications
www.ema.europa.eu
February 27, 2026 at 5:08 PM