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Ropeginterferon alfa-2b
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FDA Rejects Ropeginterferon alfa-2b for Polycythemia Vera
Although their drug
ropeginterferon
alfa
-
2b
is sold in the European Union as Besremi, the FDA has rejected the approval request for use in the United States.
Although their drug
ropeginterferon
alfa
-
2b
is sold in the European Union as Besremi, the FDA has rejected the approval request for use in the United States.
Manouche
in
MPN Voice
3 years ago
PharmaEssentia Provides U.S. Regulatory Update on Ropeginterferon alfa-2b-njft for the Treatment of Polycythemia Vera (PV)
-Regulatory-Update-on-
Ropeginterferon
-
alfa
-
2b
-njft-for-the-Treatment-of-Polycythemia-Vera-PV
-Regulatory-Update-on-
Ropeginterferon
-
alfa
-
2b
-njft-for-the-Treatment-of-Polycythemia-Vera-PV
Manouche
in
MPN Voice
3 years ago
Email to the CEO of the MHRA - please also email this lady
Having done some research I read that Besremi
Ropeginterferon
Alfa
-
2b
has been deemed safe and efficacious in the US ( as of 15/03/2021) as it has also in Europe. I wonder therefore why this drug is not licensed for use in the UK?
Having done some research I read that Besremi
Ropeginterferon
Alfa
-
2b
has been deemed safe and efficacious in the US ( as of 15/03/2021) as it has also in Europe. I wonder therefore why this drug is not licensed for use in the UK?
Loubprv
Volunteer
in
MPN Voice
3 years ago
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Greater Understanding of PV, ET Drives Potential New Treatment Options
“Continued high-impact research may soon foster the development of disease-modifying therapies for PV and ET and satisfy this need for the optimal management of patients with these MPNs,” they said. Researchers are also determining how to best optimize current treatment options, including JAK inhibitors
“Continued high-impact research may soon foster the development of disease-modifying therapies for PV and ET and satisfy this need for the optimal management of patients with these MPNs,” they said. Researchers are also determining how to best optimize current treatment options, including JAK inhibitors
Manouche
in
MPN Voice
3 years ago
Roxadustat and thyroid-stimulating hormone suppression
Just posting this so that it has been posted. I have my doubts it will be relevant to more than a handful - but I could be wrong. [i]
Roxadustat and thyroid-stimulating hormone suppression
Atsuyuki Tokuyama, Hiroyuki Kadoya, Atsushi Obata, Takahiro Obata, Tamaki Sasaki, Naoki Kashihara Clinical
Just posting this so that it has been posted. I have my doubts it will be relevant to more than a handful - but I could be wrong. [i]
Roxadustat and thyroid-stimulating hormone suppression
Atsuyuki Tokuyama, Hiroyuki Kadoya, Atsushi Obata, Takahiro Obata, Tamaki Sasaki, Naoki Kashihara Clinical
helvella
Thyroid UK
in
Thyroid UK
3 years ago
Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study)
This study aimed to compare the efficacy and safety of
ropeginterferon
alfa
-
2b
on top of the standard phlebotomy regimen with phlebotomy alone. https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(20)30373-2/fulltext
This study aimed to compare the efficacy and safety of
ropeginterferon
alfa
-
2b
on top of the standard phlebotomy regimen with phlebotomy alone. https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(20)30373-2/fulltext
Manouche
in
MPN Voice
3 years ago
PharmaEssentia Initiates Pivotal Trial of Ropeginterferon alfa-2b to Treat Essential Thrombocythemia
« With a diversifying pipeline, the company is evaluating applications for pegylated interferon to address underserved hematologic cancers » https://www.pharmiweb.com/press-release/2021-01-07/pharmaessentia-initiates-pivotal-trial-of-
ropeginterferon
-
alfa
-
2b
-to-treat-essential-thrombocythemia
« With a diversifying pipeline, the company is evaluating applications for pegylated interferon to address underserved hematologic cancers » https://www.pharmiweb.com/press-release/2021-01-07/pharmaessentia-initiates-pivotal-trial-of-
ropeginterferon
-
alfa
-
2b
-to-treat-essential-thrombocythemia
Manouche
in
MPN Voice
3 years ago
AOP Orphan announces 5-year results on BESREMi® in PV at the ASH Annual Meeting 2020
https://edomexaldia.com/2020/12/06/aop-orphan-announces-5-year-results-on-besremi-
ropeginterferon
-
alfa
-
2b
-in-pv-at-the-ash-annual-meeting-2020/
https://edomexaldia.com/2020/12/06/aop-orphan-announces-5-year-results-on-besremi-
ropeginterferon
-
alfa
-
2b
-in-pv-at-the-ash-annual-meeting-2020/
Manouche
in
MPN Voice
4 years ago
ICC ruled in favor of AOP Orphan Pharmaceuticals AG in arbitration proceedings pertaining to BESREMi®
«After two and a half years of arbitration proceedings concerning BESREMi® (
Ropeginterferon
alfa
-
2b
), the decision by the ICC Arbitral Tribunal has now been made. In 2017 PharmaEssentia had attempted to terminate the contractual agreement with AOP Orphan.
«After two and a half years of arbitration proceedings concerning BESREMi® (
Ropeginterferon
alfa
-
2b
), the decision by the ICC Arbitral Tribunal has now been made. In 2017 PharmaEssentia had attempted to terminate the contractual agreement with AOP Orphan.
Manouche
in
MPN Voice
4 years ago
On bone marrow biopsy (BMB)?
Hello everyone, People with PV/ET regularly (e.g., per month) test their blood to keep track of cell counts and other things. How about bone marrow biopsy (BMB)? Are there repeats of BMB test to check changes after the first one that was performed to detect any mutation like JK2 ? If yes, how the results
Hello everyone, People with PV/ET regularly (e.g., per month) test their blood to keep track of cell counts and other things. How about bone marrow biopsy (BMB)? Are there repeats of BMB test to check changes after the first one that was performed to detect any mutation like JK2 ? If yes, how the results
samiris
in
MPN Voice
4 years ago
Ropeginterferon Alfa-2b Helps Maintain Hematocrit Control for Low-Risk Polycythemia Vera
« More patients with low-risk polycythemia vera treated with
ropeginterferon
alfa
-
2b
were able to maintain hematocrit levels at or below 45% compared with those who received monthly phlebotomy alone. » https://www.onclive.com/view/added-cytoreductive-therapy-helps-maintain-hematocrit-control-for-low-risk-pv-patients
« More patients with low-risk polycythemia vera treated with
ropeginterferon
alfa
-
2b
were able to maintain hematocrit levels at or below 45% compared with those who received monthly phlebotomy alone. » https://www.onclive.com/view/added-cytoreductive-therapy-helps-maintain-hematocrit-control-for-low-risk-pv-patients
Manouche
in
MPN Voice
4 years ago
FDA Accepts Application for Ropeginterferon Alfa-2b for Polycythemia Vera
The FDA has accepted a Biologics License Application (BLA) for
ropeginterferon
alfa
-
2b
(P1101) for use as a treatment for patients with polycythemia vera (PV) in the absence of symptomatic splenomegaly, according to PharmaEssentia Corporation, the manufacturer of the novel pegylated interferon.
The FDA has accepted a Biologics License Application (BLA) for
ropeginterferon
alfa
-
2b
(P1101) for use as a treatment for patients with polycythemia vera (PV) in the absence of symptomatic splenomegaly, according to PharmaEssentia Corporation, the manufacturer of the novel pegylated interferon.
Manouche
in
MPN Voice
4 years ago
Ropeginterferon superior to Interferon and HU in PV patients
TAKE-HOME MESSAGE In this phase III study and its associated extension study, 257 patients with polycythemia vera (PV) were randomized to receive a monopegylated interferon,
ropeginterferon
alfa
-
2b
, or hydroxyurea.
TAKE-HOME MESSAGE In this phase III study and its associated extension study, 257 patients with polycythemia vera (PV) were randomized to receive a monopegylated interferon,
ropeginterferon
alfa
-
2b
, or hydroxyurea.
JT_Marlin
in
MPN Voice
4 years ago
BESREMi Ropeginterferon alfa-2b is available in Austria and Germany
After hearing very encouraging information regarding effectiveness of BESREMi
Ropeginterferon
alfa
-
2b
from the doctor in my local clinic (based on clinical trial they run for several years) I checked the price in Austrian drug store.
After hearing very encouraging information regarding effectiveness of BESREMi
Ropeginterferon
alfa
-
2b
from the doctor in my local clinic (based on clinical trial they run for several years) I checked the price in Austrian drug store.
Alexbits
in
MPN Voice
5 years ago
Dukoral - Cholera Vaccine
I just took my first dose of Dukoral. I will wait a week to take the second dose. A friend of mine who lives outside of Detroit Michigan went over to Windsor and made the purchase and had no problem crossing the border with it. He declared it as an over the counter diarrhea med. The agent laughed
I just took my first dose of Dukoral. I will wait a week to take the second dose. A friend of mine who lives outside of Detroit Michigan went over to Windsor and made the purchase and had no problem crossing the border with it. He declared it as an over the counter diarrhea med. The agent laughed
Drphil1938
in
Advanced Prostate Cancer
5 years ago
Ropeg versus HU/BAT results after 3 years
“After 36 months of treatment
Ropeginterferon
alfa
-
2b
sustained higher CHR response rates compared to HU/BAT (70.5% vs. 51.4%; p=0.0122).
“After 36 months of treatment
Ropeginterferon
alfa
-
2b
sustained higher CHR response rates compared to HU/BAT (70.5% vs. 51.4%; p=0.0122).
Paul123456
in
MPN Voice
6 years ago
Pipeline of ataxia related research.
Found a report online being offered for $2000 that summarizes the current pipeline of all known ataxia related drugs. - - - Spinocerebellar Ataxia (SCA) - Companies Involved in Therapeutics Development Bio Blast Pharma Ltd Biohaven Pharmaceutical Holding Company Ltd Cadent Therapeutics Ionis Pharmaceuticals
Found a report online being offered for $2000 that summarizes the current pipeline of all known ataxia related drugs. - - - Spinocerebellar Ataxia (SCA) - Companies Involved in Therapeutics Development Bio Blast Pharma Ltd Biohaven Pharmaceutical Holding Company Ltd Cadent Therapeutics Ionis Pharmaceuticals
sunvox
in
Ataxia UK
6 years ago
EMA approval for ropeginterferon alpha2b?
Hi, I found a article dated 11/06 on businesswire.com with the headline : AOP Orphan Announces Progress of its European Marketing Authorization Procedure of
Ropeginterferon
alfa
-
2b
The article mentions that The EUropean Medical Agency will make a final decision on whether Ropeg can be marketed in the
Hi, I found a article dated 11/06 on businesswire.com with the headline : AOP Orphan Announces Progress of its European Marketing Authorization Procedure of
Ropeginterferon
alfa
-
2b
The article mentions that The EUropean Medical Agency will make a final decision on whether Ropeg can be marketed in the
JohnSC
in
MPN Voice
6 years ago
Knight five
Myself and a wee Baroness posing with Sir Alka Seltzer Cheesemonger This particular knight was a thrice married man who once went into battle wearing nothing but a smile. He stoutly refused to use a sword and when that tactic finally caught up with him, his replacement was severed. Forever more he was
Myself and a wee Baroness posing with Sir Alka Seltzer Cheesemonger This particular knight was a thrice married man who once went into battle wearing nothing but a smile. He stoutly refused to use a sword and when that tactic finally caught up with him, his replacement was severed. Forever more he was
BaronC
in
Headway
7 years ago
Bloated constipation due to ibs
So I've had ibs for a year and have found its triggered by pork and stress. I've cut out the pork apart from the odd accident but stress is a different matter. I recently flew to majorca . The stress caused diarrhoea so took an imodium and u haven't on since. The pain is excruciating but u don't want
So I've had ibs for a year and have found its triggered by pork and stress. I've cut out the pork apart from the odd accident but stress is a different matter. I recently flew to majorca . The stress caused diarrhoea so took an imodium and u haven't on since. The pain is excruciating but u don't want
Deb131
in
IBS Network
7 years ago
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