🚀 4 Core Policy Decisions for Setting Up an Expanded Access Program (EAP)
When establishing an Expanded Access Program (EAP), making the right policy decisions early on is crucial. Here are the four key considerations:
#ExpandedAccess #EarlyAccess #EAP #CompassionateUse
When establishing an Expanded Access Program (EAP), making the right policy decisions early on is crucial. Here are the four key considerations:
#ExpandedAccess #EarlyAccess #EAP #CompassionateUse
April 1, 2025 at 3:54 PM
🚀 4 Core Policy Decisions for Setting Up an Expanded Access Program (EAP)
When establishing an Expanded Access Program (EAP), making the right policy decisions early on is crucial. Here are the four key considerations:
#ExpandedAccess #EarlyAccess #EAP #CompassionateUse
When establishing an Expanded Access Program (EAP), making the right policy decisions early on is crucial. Here are the four key considerations:
#ExpandedAccess #EarlyAccess #EAP #CompassionateUse
ALS Access Update: https://bit.ly/3MtWLSG
An expanded access program for the experimental therapy MN 166 has reached fifty percent enrollment.
#ALS #ALSNewsToday #Bionews #ALSResearch #ExpandedAccess #ClinicalTrials #ALSTreatment #RareDiseaseNews
An expanded access program for the experimental therapy MN 166 has reached fifty percent enrollment.
#ALS #ALSNewsToday #Bionews #ALSResearch #ExpandedAccess #ClinicalTrials #ALSTreatment #RareDiseaseNews
February 6, 2026 at 8:02 PM
ALS Access Update: https://bit.ly/3MtWLSG
An expanded access program for the experimental therapy MN 166 has reached fifty percent enrollment.
#ALS #ALSNewsToday #Bionews #ALSResearch #ExpandedAccess #ClinicalTrials #ALSTreatment #RareDiseaseNews
An expanded access program for the experimental therapy MN 166 has reached fifty percent enrollment.
#ALS #ALSNewsToday #Bionews #ALSResearch #ExpandedAccess #ClinicalTrials #ALSTreatment #RareDiseaseNews
Where you live shouldn’t limit your access to treatments and clinical trials.
That’s why we are proud to lead the FIRST virtual clinical study via Clene's #ExpandedAccess Program
Learn more: www.synapticure.com/blog/increas...
#ALSAwareness #ALSResearch #EndALS
That’s why we are proud to lead the FIRST virtual clinical study via Clene's #ExpandedAccess Program
Learn more: www.synapticure.com/blog/increas...
#ALSAwareness #ALSResearch #EndALS
May 6, 2025 at 2:04 PM
Where you live shouldn’t limit your access to treatments and clinical trials.
That’s why we are proud to lead the FIRST virtual clinical study via Clene's #ExpandedAccess Program
Learn more: www.synapticure.com/blog/increas...
#ALSAwareness #ALSResearch #EndALS
That’s why we are proud to lead the FIRST virtual clinical study via Clene's #ExpandedAccess Program
Learn more: www.synapticure.com/blog/increas...
#ALSAwareness #ALSResearch #EndALS
🚀How early could an EAP be launched?
It's all about the risk benefit balance
When should a Global Expanded Access Program (EAP) be launched? The answer depends on compelling clinical data—sometimes as early as Phase 1 or Phase 2.
#ExpandedAccess #EarlyAccess #EAP
It's all about the risk benefit balance
When should a Global Expanded Access Program (EAP) be launched? The answer depends on compelling clinical data—sometimes as early as Phase 1 or Phase 2.
#ExpandedAccess #EarlyAccess #EAP
April 11, 2025 at 11:37 AM
🚀How early could an EAP be launched?
It's all about the risk benefit balance
When should a Global Expanded Access Program (EAP) be launched? The answer depends on compelling clinical data—sometimes as early as Phase 1 or Phase 2.
#ExpandedAccess #EarlyAccess #EAP
It's all about the risk benefit balance
When should a Global Expanded Access Program (EAP) be launched? The answer depends on compelling clinical data—sometimes as early as Phase 1 or Phase 2.
#ExpandedAccess #EarlyAccess #EAP
🚀 Pivotal Data release triggers requests for Early Access.
When pivotal clinical data is released—whether at ASCO or another major medical symposium—healthcare professionals worldwide ask the same critical question:
#ExpandedAccess #PivotalData #EarlyAccess #ASCO #ClinicalTrials
When pivotal clinical data is released—whether at ASCO or another major medical symposium—healthcare professionals worldwide ask the same critical question:
#ExpandedAccess #PivotalData #EarlyAccess #ASCO #ClinicalTrials
April 4, 2025 at 9:14 AM
🚀 Pivotal Data release triggers requests for Early Access.
When pivotal clinical data is released—whether at ASCO or another major medical symposium—healthcare professionals worldwide ask the same critical question:
#ExpandedAccess #PivotalData #EarlyAccess #ASCO #ClinicalTrials
When pivotal clinical data is released—whether at ASCO or another major medical symposium—healthcare professionals worldwide ask the same critical question:
#ExpandedAccess #PivotalData #EarlyAccess #ASCO #ClinicalTrials
🚀 Companies Starting EAPs After First Approval
Some pharmaceutical companies choose to initiate an Expanded Access Program (EAP) only after securing their first regulatory approval.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
Some pharmaceutical companies choose to initiate an Expanded Access Program (EAP) only after securing their first regulatory approval.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
April 2, 2025 at 11:30 AM
🚀 Companies Starting EAPs After First Approval
Some pharmaceutical companies choose to initiate an Expanded Access Program (EAP) only after securing their first regulatory approval.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
Some pharmaceutical companies choose to initiate an Expanded Access Program (EAP) only after securing their first regulatory approval.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
🚀 Risk minimisation: Launchng an EAP post first country regulatory approval.
Can EAPs be launched after the first regulatory approval has been granted? Some companies only commence EAPs at this time.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
Can EAPs be launched after the first regulatory approval has been granted? Some companies only commence EAPs at this time.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
April 2, 2025 at 10:30 AM
🚀 Risk minimisation: Launchng an EAP post first country regulatory approval.
Can EAPs be launched after the first regulatory approval has been granted? Some companies only commence EAPs at this time.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
Can EAPs be launched after the first regulatory approval has been granted? Some companies only commence EAPs at this time.
#ExpandedAccess #EarlyAccess #EAP #DrugApproval
#mRNAvaccines #GLP1 #obesity #CARTcelltherapies #oncology #PCSK9inhibitors #HepatitisC #Immunotherapy #checkpointinhibitors #RSVvaccines #Genetherapies #rarediseases #antivirals #Biosimilars #expandedaccess #biologics #HIV #Migraine #CGRPinhibitors #antifungals #precisionmedicine
zurl.co/3UDz7
zurl.co/3UDz7
22-23 PHARMA - Fast and the curious
This month: the NHS as a dystopian game of Tetris, the GLP-1 explosion and its impact on future meds, plus deep dives into AI in pharma, reproductive health, and Trump’s healthcare influence. Also, co...
magazine.pharmatimes.com
April 2, 2026 at 11:21 AM
#drugdevelopment #Clinicaltrials #RandD #clinicalresearch #neurodegeneration #regenerativemedicine #clinicaltrialdevelopments #orphandrugdesignation #preclinicaldata #fasttrackdesignation #expandedaccess #FDApriorityreview #clinicalprogress #strategicfunding
zurl.co/jmZiW
zurl.co/jmZiW
Q3 Clinical trials round-up: July to September 2025
As the third quarter of 2025 draws to a close, the clinical research landscape has been marked by a surge of promising data and regulatory milestones.
zurl.co
October 15, 2025 at 11:15 AM
#CellandGeneTherapy #CGT #Uniphar #personalisedmedicine #Celltherapy #CARTcelltherapy #Genetherapy #CGTlandscape #CGTpipeline #genetherapytrials #Expandedaccess #NamedPatientSupply #FreeofChargeaccess #FOCaccess #MAPs #EAPs #realworldevidencegeneration #marketreadiness
zurl.co/2pdyj
zurl.co/2pdyj
firstwordpharma.com
September 29, 2025 at 10:58 AM
#NHSdiabetesstrategy #GLP1 #NHS #type2diabetes #personalisedapproach #expandedaccess #GLP1agonisttherapies #NHScosts #Individualisedcare #NICEdraftguidance #NICE #SGLT2inhibitors #GLP1receptoragonists #NICEguidance #NHS10Yearplan #patientadvocacy #DiabetesUK
pharmaphorum.com/news/new-nhs...
pharmaphorum.com/news/new-nhs...
New NHS diabetes strategy could raise GLP-1 drug use
New guidelines on NHS management of type 2 diabetes will introduce a more personalised approach that could see expanded access to drug treatments
pharmaphorum.com
September 3, 2025 at 8:20 AM
@democrats.senate.gov @housedemocrats.bsky.social
Something deeply troubling is happening in the ultra-rare Galactosemia community.
In December, Cycle pharma aquired Applied Therapeutics, Inc. Therapeutics
During this transition, patients were cut out of communication with both companies.
Something deeply troubling is happening in the ultra-rare Galactosemia community.
In December, Cycle pharma aquired Applied Therapeutics, Inc. Therapeutics
During this transition, patients were cut out of communication with both companies.
#raredisease #patientaccess #expandedaccess #galactosemia #drugdevelopment #patientsfirst | Gillian Sapia RN | 10 comments
Something deeply troubling is happening in the ultra-rare Galactosemia community.
In December, Applied Therapeutics, Inc. Therapeutics was acquired by Cycle Pharmaceuticals Pharmaceuticals.
Durin...
www.linkedin.com
March 14, 2026 at 2:29 PM
@democrats.senate.gov @housedemocrats.bsky.social
Something deeply troubling is happening in the ultra-rare Galactosemia community.
In December, Cycle pharma aquired Applied Therapeutics, Inc. Therapeutics
During this transition, patients were cut out of communication with both companies.
Something deeply troubling is happening in the ultra-rare Galactosemia community.
In December, Cycle pharma aquired Applied Therapeutics, Inc. Therapeutics
During this transition, patients were cut out of communication with both companies.
thank you @medsci.ox.ac.uk for working together to get advances in health & care to people most likely to benefit.
1) Is #informedconsent part of the protocol?
2) Might a #HumanImmuneMonitoringCenter mitigate risk of adverse events?
3) #Expandedaccess to parents & caregivers? #ItTakesaVillage
1) Is #informedconsent part of the protocol?
2) Might a #HumanImmuneMonitoringCenter mitigate risk of adverse events?
3) #Expandedaccess to parents & caregivers? #ItTakesaVillage
NEWS: New clinical trials for malaria vaccine begin in Burkina Faso
These studies are expected to provide proof-of-concept for the use of a multi-stage vaccine to extend the protection against malaria.
These studies are expected to provide proof-of-concept for the use of a multi-stage vaccine to extend the protection against malaria.
New clinical trials for malaria vaccine begin in Burkina Faso
Vaccinations have started at the Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-URCN), Burkina Faso for two clinical trials to assess the blood-stage malaria vaccine candidates R78C and RH5.1 with Matrix-M (developed by the Draper Lab in the Department of Paediatrics), in combination with the R21/Matrix-M vaccine, which targets the earlier liver-stage.
f.mtr.cool
March 2, 2026 at 4:34 PM
thank you @medsci.ox.ac.uk for working together to get advances in health & care to people most likely to benefit.
1) Is #informedconsent part of the protocol?
2) Might a #HumanImmuneMonitoringCenter mitigate risk of adverse events?
3) #Expandedaccess to parents & caregivers? #ItTakesaVillage
1) Is #informedconsent part of the protocol?
2) Might a #HumanImmuneMonitoringCenter mitigate risk of adverse events?
3) #Expandedaccess to parents & caregivers? #ItTakesaVillage
Revolution Medicines has started shipping its experimental pancreatic cancer drug daraxonrasib through expanded access while preparing FD…
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionmedicine
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionm…
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionmedicine
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionm…
New Pancreatic Cancer Drug Ships to Patients
Revolution Medicines has started shipping its experimental pancreatic cancer drug daraxonrasib through expanded access while preparing FD…
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionmedicine
news.gmj.ge
June 9, 2026 at 12:07 PM
Revolution Medicines has started shipping its experimental pancreatic cancer drug daraxonrasib through expanded access while preparing FD…
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionmedicine
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionm…
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionmedicine
#Daraxonrasib #Expandedaccess #KRASinhibitor #Pancreaticcancer #Precisionm…