📰Latest News Alert
Intercept, on heels of Ocaliva withdrawal, restructures with 146 layoffs . After a long run of regulatory stumbles and the recent wit | "Following the withdrawal of Ocaliva from... www.fiercepharma.com...
Intercept, on heels of Ocaliva withdrawal, restructures with 146 layoffs . After a long run of regulatory stumbles and the recent wit | "Following the withdrawal of Ocaliva from... www.fiercepharma.com...
December 17, 2025 at 8:01 PM
📰Latest News Alert
Intercept, on heels of Ocaliva withdrawal, restructures with 146 layoffs . After a long run of regulatory stumbles and the recent wit | "Following the withdrawal of Ocaliva from... www.fiercepharma.com...
Intercept, on heels of Ocaliva withdrawal, restructures with 146 layoffs . After a long run of regulatory stumbles and the recent wit | "Following the withdrawal of Ocaliva from... www.fiercepharma.com...
Thank you to all who attended & made our educational webinar last Wednesday a successful event! We had attendees from Dubai to Taiwan and back to the US hear our expert panel share their valuable insights & practical advice to #patients!
View webinar here: youtu.be/wSRUQV3hC-4
#PBC #ocaliva
View webinar here: youtu.be/wSRUQV3hC-4
#PBC #ocaliva
October 21, 2025 at 5:42 AM
Thank you to all who attended & made our educational webinar last Wednesday a successful event! We had attendees from Dubai to Taiwan and back to the US hear our expert panel share their valuable insights & practical advice to #patients!
View webinar here: youtu.be/wSRUQV3hC-4
#PBC #ocaliva
View webinar here: youtu.be/wSRUQV3hC-4
#PBC #ocaliva
We are partnering with #PBCers Organization for this important patient-facing webinar to give #patients and #caregivers an opportunity to ask "what's do I do? next" after the voluntary withdrawal of #Ocaliva.
Come prepared with questions & register today 💜
liveralliance.org/events/navig...
Come prepared with questions & register today 💜
liveralliance.org/events/navig...
October 7, 2025 at 2:47 AM
We are partnering with #PBCers Organization for this important patient-facing webinar to give #patients and #caregivers an opportunity to ask "what's do I do? next" after the voluntary withdrawal of #Ocaliva.
Come prepared with questions & register today 💜
liveralliance.org/events/navig...
Come prepared with questions & register today 💜
liveralliance.org/events/navig...
Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary cholangitis (PBC) after the FDA requested its removal and placed ongoing trials on clinical hold.
https://www.medpagetoday.com/gastroenterology/generalhepatology/117441
https://www.medpagetoday.com/gastroenterology/generalhepatology/117441
Liver Disease Drug Pulled From the Market
Intercept removed obeticholic acid for primary biliary cholangitis at FDA's request
www.medpagetoday.com
September 12, 2025 at 8:34 PM
Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary cholangitis (PBC) after the FDA requested its removal and placed ongoing trials on clinical hold.
https://www.medpagetoday.com/gastroenterology/generalhepatology/117441
https://www.medpagetoday.com/gastroenterology/generalhepatology/117441
Liver Disease Drug Pulled From the Market
(MedPage Today) -- Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary cholangitis (PBC) after the FDA requested its removal and placed ongoing trials on clinical hold. The move... Source…
(MedPage Today) -- Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary cholangitis (PBC) after the FDA requested its removal and placed ongoing trials on clinical hold. The move... Source…
Liver Disease Drug Pulled From the Market
(MedPage Today) -- Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary cholangitis (PBC) after the FDA requested its removal and placed ongoing trials on clinical hold. The move... Source link
n24usa.com
September 12, 2025 at 6:43 PM
Liver Disease Drug Pulled From the Market
(MedPage Today) -- Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary cholangitis (PBC) after the FDA requested its removal and placed ongoing trials on clinical hold. The move... Source…
(MedPage Today) -- Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary cholangitis (PBC) after the FDA requested its removal and placed ongoing trials on clinical hold. The move... Source…
Alfasigma's $800m buyout of #Intercept is starting to look like a poor bet as its only product, Ocaliva, is pulled from the market.
pharmaphorum.com/news/interce...
pharmaphorum.com/news/interce...
Intercept pulls Ocaliva off the market in the US
Alfasigma's $800m buyout of Intercept is starting to look like a poor bet as its only product, Ocaliva, is pulled from the market
pharmaphorum.com
September 12, 2025 at 8:45 AM
Alfasigma's $800m buyout of #Intercept is starting to look like a poor bet as its only product, Ocaliva, is pulled from the market.
pharmaphorum.com/news/interce...
pharmaphorum.com/news/interce...
Say it Ain't So...Ocaliva for PBC withdrawn
(and another one bites the dust)
Just wanted to share this, as one who had placed patients with PBC (Primary Biliary Cholangitis) on Ocaliva (obeticholic acid)
Fortunately other options available/in pipeline.
#GIsky #Medsky #IMsky
(and another one bites the dust)
Just wanted to share this, as one who had placed patients with PBC (Primary Biliary Cholangitis) on Ocaliva (obeticholic acid)
Fortunately other options available/in pipeline.
#GIsky #Medsky #IMsky
September 11, 2025 at 8:12 PM
Many patients had been on Ocaliva for years with a good response and tolerability.
Since 2016, intercept invested a significant amount of time, effort and resources towards elevating patient voices, raising awareness and bridging the knowledge gap.
Let’s at least give them credit for this.
Since 2016, intercept invested a significant amount of time, effort and resources towards elevating patient voices, raising awareness and bridging the knowledge gap.
Let’s at least give them credit for this.
September 11, 2025 at 7:35 PM
Many patients had been on Ocaliva for years with a good response and tolerability.
Since 2016, intercept invested a significant amount of time, effort and resources towards elevating patient voices, raising awareness and bridging the knowledge gap.
Let’s at least give them credit for this.
Since 2016, intercept invested a significant amount of time, effort and resources towards elevating patient voices, raising awareness and bridging the knowledge gap.
Let’s at least give them credit for this.
The voluntary withdrawal of Ocaliva by Intercept for PBC is not a cause for celebration.
It is certainly not an action that enhances the safety of the American public by protecting it from a nefarious, hepatotoxic drug.
Ocaliva is not troglitazone or bromfenac.
#liversky
It is certainly not an action that enhances the safety of the American public by protecting it from a nefarious, hepatotoxic drug.
Ocaliva is not troglitazone or bromfenac.
#liversky
September 11, 2025 at 7:30 PM
The voluntary withdrawal of Ocaliva by Intercept for PBC is not a cause for celebration.
It is certainly not an action that enhances the safety of the American public by protecting it from a nefarious, hepatotoxic drug.
Ocaliva is not troglitazone or bromfenac.
#liversky
It is certainly not an action that enhances the safety of the American public by protecting it from a nefarious, hepatotoxic drug.
Ocaliva is not troglitazone or bromfenac.
#liversky
doi.org/10.1042/BCJ2... : Ariane and Audrey-Anne have tested the effects of omega-based pharmaco-nutraceutical combinations on the anti-cholestatic and anti-fibrotic properties of low doses of Ocaliva, a drug that was approved but then withdrawn in Europe for the PBC treatment.
July 26, 2025 at 1:57 PM
doi.org/10.1042/BCJ2... : Ariane and Audrey-Anne have tested the effects of omega-based pharmaco-nutraceutical combinations on the anti-cholestatic and anti-fibrotic properties of low doses of Ocaliva, a drug that was approved but then withdrawn in Europe for the PBC treatment.
doi.org/10.1042/BCJ2...: When a drug is effective, but has a narrow therapeutic window. Either throw it out, or try to improve it. Ariane and Audrey-Anne have explored this second option for Ocaliva.
#primary_biliary_cholangitis
#primary_sclerosing_cholangitis
#Ocaliva
#Pharmaco-nutraceutics
#primary_biliary_cholangitis
#primary_sclerosing_cholangitis
#Ocaliva
#Pharmaco-nutraceutics
July 26, 2025 at 1:55 PM
doi.org/10.1042/BCJ2...: When a drug is effective, but has a narrow therapeutic window. Either throw it out, or try to improve it. Ariane and Audrey-Anne have explored this second option for Ocaliva.
#primary_biliary_cholangitis
#primary_sclerosing_cholangitis
#Ocaliva
#Pharmaco-nutraceutics
#primary_biliary_cholangitis
#primary_sclerosing_cholangitis
#Ocaliva
#Pharmaco-nutraceutics
🚨La FDA continúa identificando el uso de Ocaliva® (ácido obeticólico) en pacientes con colangitis biliar primaria y cirrosis hepática avanzada, pese a sus contraindicaciones por riesgo de hepatotoxicidad grave. En #español 🔎 www.saludyfarmacos.org/boletin-farm... #ÁcidoObeticólico #Hepática #FDA
April 2, 2025 at 12:47 PM
🚨La FDA continúa identificando el uso de Ocaliva® (ácido obeticólico) en pacientes con colangitis biliar primaria y cirrosis hepática avanzada, pese a sus contraindicaciones por riesgo de hepatotoxicidad grave. En #español 🔎 www.saludyfarmacos.org/boletin-farm... #ÁcidoObeticólico #Hepática #FDA
Obeticholic Acid (OCALIVA): A Liver Disease Drug the FDA Never Should Have Approved: www.worstpills.org/newsletters/... (subscription required)
Obeticholic Acid (OCALIVA): A Liver Disease Drug the FDA Never Should Have Approved
Granted accelerated approval by the Food and Drug Administration (FDA) in 2016, obeticholic acid (OCALIVA) is an expensive oral drug that is a second-line treatment for adults with a liver disease kno...
www.worstpills.org
February 11, 2025 at 4:42 PM
Obeticholic Acid (OCALIVA): A Liver Disease Drug the FDA Never Should Have Approved: www.worstpills.org/newsletters/... (subscription required)
Out now! The February 2025 Worst Pills, Best Pills News, featuring: “Obeticholic Acid (OCALIVA): A Liver Disease Drug the FDA Never Should Have Approved,” “The FDA, User Fees and Trump 2.0” & more: www.worstpills.org/newsletters/... (subscription required)
February 3, 2025 at 3:56 PM
Out now! The February 2025 Worst Pills, Best Pills News, featuring: “Obeticholic Acid (OCALIVA): A Liver Disease Drug the FDA Never Should Have Approved,” “The FDA, User Fees and Trump 2.0” & more: www.worstpills.org/newsletters/... (subscription required)
Gastroenterology>General Hepatology
FDA Issues Safety Alert on Liver Disease Drug.
— Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis.
by Ian Ingram, Managing Editor, MedPage Today www.medpagetoday.com/gastroentero...
FDA Issues Safety Alert on Liver Disease Drug.
— Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis.
by Ian Ingram, Managing Editor, MedPage Today www.medpagetoday.com/gastroentero...
FDA Issues Safety Alert on Liver Disease Drug
Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis
www.medpagetoday.com
December 14, 2024 at 7:37 AM
Gastroenterology>General Hepatology
FDA Issues Safety Alert on Liver Disease Drug.
— Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis.
by Ian Ingram, Managing Editor, MedPage Today www.medpagetoday.com/gastroentero...
FDA Issues Safety Alert on Liver Disease Drug.
— Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis.
by Ian Ingram, Managing Editor, MedPage Today www.medpagetoday.com/gastroentero...
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Serious Liver Injury Being Observed in Patients without Cirrhosis posted 2024-12-12
Additional Details Here.
Additional Details Here.
December 13, 2024 at 11:05 AM
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Serious Liver Injury Being Observed in Patients without Cirrhosis posted 2024-12-12
Additional Details Here.
Additional Details Here.
Description: Based on its review of postmarket clinical trial data, the U.S. Food and Drug Administration (FDA) identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver.
December 13, 2024 at 6:00 AM
Description: Based on its review of postmarket clinical trial data, the U.S. Food and Drug Administration (FDA) identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver.
Link: http://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-serious-liver-injury
Date: 2024-12-12
Date: 2024-12-12
December 13, 2024 at 6:00 AM
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Serious Liver Injury Being Observed in Patients without Cirrhosis
December 13, 2024 at 6:00 AM
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Serious Liver Injury Being Observed in Patients without Cirrhosis
Thoughts on this? >> 'Serious liver injury' cases on Ocaliva lead FDA to call for
monitoring: The FDA said it continues to monitor the safety of Intercept Pharmaceuticals… >> Comment below! #strategy #competitiveintelligence #marketing #biotech #productmarketing #pharmaceutical #pharma #healthcare
monitoring: The FDA said it continues to monitor the safety of Intercept Pharmaceuticals… >> Comment below! #strategy #competitiveintelligence #marketing #biotech #productmarketing #pharmaceutical #pharma #healthcare
'Serious liver injury' cases on Ocaliva lead FDA to call for
monitoring
The FDA said it continues to monitor the safety of Intercept Pharmaceuticals and Alfasigma’s rare liver disease drug Ocaliva after seeing evidence of “serious liver injury” in a post-approval clinical trial. The agency announced Thursday ...
dlvr.it
December 12, 2024 at 9:24 PM
Thoughts on this? >> 'Serious liver injury' cases on Ocaliva lead FDA to call for
monitoring: The FDA said it continues to monitor the safety of Intercept Pharmaceuticals… >> Comment below! #strategy #competitiveintelligence #marketing #biotech #productmarketing #pharmaceutical #pharma #healthcare
monitoring: The FDA said it continues to monitor the safety of Intercept Pharmaceuticals… >> Comment below! #strategy #competitiveintelligence #marketing #biotech #productmarketing #pharmaceutical #pharma #healthcare
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
Monitor liver tests often for early identification of worsening liver function www.fda.gov/drugs/drug-s...
Monitor liver tests often for early identification of worsening liver function www.fda.gov/drugs/drug-s...
Serious liver injury being observed in patients without cirrhosis taki
Monitor liver tests often for early identification of worsening liver function
www.fda.gov
December 12, 2024 at 5:15 PM
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
Monitor liver tests often for early identification of worsening liver function www.fda.gov/drugs/drug-s...
Monitor liver tests often for early identification of worsening liver function www.fda.gov/drugs/drug-s...
Thoughts on this? >> Advanz Pharma faces revocation of European authorization for
liver disease drug Ocaliva: The conditional marketing authorization for Advanz Pharma’s… >> Comment below! #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #healthcare #biotech #pharma
liver disease drug Ocaliva: The conditional marketing authorization for Advanz Pharma’s… >> Comment below! #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #healthcare #biotech #pharma
Advanz Pharma faces revocation of European authorization for
liver disease drug Ocaliva
The conditional marketing authorization for Advanz Pharma’s liver disease treatment Ocaliva has been revoked following a decision by the General Court of the European Union, the company announced Wednesday. The court decided not to extend ...
dlvr.it
November 27, 2024 at 5:41 PM
Thoughts on this? >> Advanz Pharma faces revocation of European authorization for
liver disease drug Ocaliva: The conditional marketing authorization for Advanz Pharma’s… >> Comment below! #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #healthcare #biotech #pharma
liver disease drug Ocaliva: The conditional marketing authorization for Advanz Pharma’s… >> Comment below! #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #healthcare #biotech #pharma
I’m glad for you. I was diagnosed in 2007. I’ve been on Urso. I was put on Ocaliva in 2015. If I lose my Medicare I won’t be able to get my meds. I’ll have to look for help. If I lose my SS I can’t pay my bills. I’m stage 3. I haven’t been responding to Urso like I was.
November 19, 2024 at 6:56 PM
I’m glad for you. I was diagnosed in 2007. I’ve been on Urso. I was put on Ocaliva in 2015. If I lose my Medicare I won’t be able to get my meds. I’ll have to look for help. If I lose my SS I can’t pay my bills. I’m stage 3. I haven’t been responding to Urso like I was.
Missed this one early today: CRL for Ocaliva obeticholic acid from Intercept Pharmaceuticals, now owned by Italian pharma Alfasigma S.p.A. following an $800m buyout. No full approval in primary biliary cholangitis; Intercept also got two CRLs in NASH/MASH. www.globenewswire.com/news-release...
Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)
MORRISTOWN, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A.,...
www.globenewswire.com
November 12, 2024 at 6:26 PM
Missed this one early today: CRL for Ocaliva obeticholic acid from Intercept Pharmaceuticals, now owned by Italian pharma Alfasigma S.p.A. following an $800m buyout. No full approval in primary biliary cholangitis; Intercept also got two CRLs in NASH/MASH. www.globenewswire.com/news-release...