Thera-Business
@therabusiness.bsky.social
Experts in regulatory services | 25+ years of experience in #evidence-based reports and #regulatory documents. #SystematicReview #MetaAnalysis #Surveys
Ottawa, Canada | https://therabusiness.com/
Ottawa, Canada | https://therabusiness.com/
A new mouse study suggests a protein produced by cancer cells may help protect against Alzheimer’s disease by breaking down brain plaques linked to cognitive decline. While still early, the findings could inform future Alzheimer’s drug research.
🔗 Read the full article below.
🔗 Read the full article below.
Cancer might protect against Alzheimer’s — this protein helps explain why
A molecule produced by cancer cells can shield the brain from Alzheimer’s disease in mice.
www.nature.com
February 6, 2026 at 7:39 PM
A new mouse study suggests a protein produced by cancer cells may help protect against Alzheimer’s disease by breaking down brain plaques linked to cognitive decline. While still early, the findings could inform future Alzheimer’s drug research.
🔗 Read the full article below.
🔗 Read the full article below.
The FDA has removed a key barrier to using RWE in application reviews. New guidance for certain device submissions says FDA may accept RWE without always requiring identifiable patient-level data, enabling broader use of large de-identified datasets.
🔗 Read the full news release below
🔗 Read the full news release below
FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
www.fda.gov
February 4, 2026 at 4:31 PM
The FDA has removed a key barrier to using RWE in application reviews. New guidance for certain device submissions says FDA may accept RWE without always requiring identifiable patient-level data, enabling broader use of large de-identified datasets.
🔗 Read the full news release below
🔗 Read the full news release below
The FDA has issued a draft guidance proposing minimal residual disease and complete response as primary endpoints for accelerated approval of multiple myeloma therapies, aiming to support more feasible trial designs while preserving long-term evidence generation.
🔗 Read the draft guidance below.
🔗 Read the draft guidance below.
MRD and Complete Response in Multiple Myeloma
This guidance provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) in multiple myeloma.
www.fda.gov
February 2, 2026 at 6:41 PM
The FDA has issued a draft guidance proposing minimal residual disease and complete response as primary endpoints for accelerated approval of multiple myeloma therapies, aiming to support more feasible trial designs while preserving long-term evidence generation.
🔗 Read the draft guidance below.
🔗 Read the draft guidance below.
Thera-Business is pleased to welcome Aliisa Heiskanen to the team as a Health Research Analyst! With her background and expertise in infectious disease epidemiology and data analysis, we look forward to her contributions.
👉 Read more about Aliisa and her role: therabusiness.com/news/welcomi...
👉 Read more about Aliisa and her role: therabusiness.com/news/welcomi...
January 30, 2026 at 3:27 PM
Thera-Business is pleased to welcome Aliisa Heiskanen to the team as a Health Research Analyst! With her background and expertise in infectious disease epidemiology and data analysis, we look forward to her contributions.
👉 Read more about Aliisa and her role: therabusiness.com/news/welcomi...
👉 Read more about Aliisa and her role: therabusiness.com/news/welcomi...
Today, we observe the National Day of Remembrance of the Quebec City Mosque Attack and Action Against Islamophobia. We honor the six lives lost in 2017 and reaffirm our commitment to standing against Islamophobia, hatred, and discrimination, and to building a more inclusive society.
January 29, 2026 at 1:51 PM
Today, we observe the National Day of Remembrance of the Quebec City Mosque Attack and Action Against Islamophobia. We honor the six lives lost in 2017 and reaffirm our commitment to standing against Islamophobia, hatred, and discrimination, and to building a more inclusive society.
Today, we observe International Holocaust Remembrance Day.
Thera-Business joins the global community in remembrance, reflection, and commitment to dignity, human rights, and justice.
Thera-Business joins the global community in remembrance, reflection, and commitment to dignity, human rights, and justice.
January 27, 2026 at 2:54 PM
Today, we observe International Holocaust Remembrance Day.
Thera-Business joins the global community in remembrance, reflection, and commitment to dignity, human rights, and justice.
Thera-Business joins the global community in remembrance, reflection, and commitment to dignity, human rights, and justice.
January is National Blood Donor Month, recognizing the vital role blood donors play in patient care. Donations help support emergency medicine, surgery, and cancer treatment year-round.
There are a few days left in the month, learn how and where you can donate at www.redcross.org
There are a few days left in the month, learn how and where you can donate at www.redcross.org
January 26, 2026 at 3:45 PM
January is National Blood Donor Month, recognizing the vital role blood donors play in patient care. Donations help support emergency medicine, surgery, and cancer treatment year-round.
There are a few days left in the month, learn how and where you can donate at www.redcross.org
There are a few days left in the month, learn how and where you can donate at www.redcross.org
CBER has outlined its 2026 guidance priorities, highlighting a strong focus on cell and gene therapy, CAR-T products, blood and blood components, and vaccines. The agenda offers early insight into evolving regulatory expectations for biologics.
Read the full CBER guidance agenda below.
Read the full CBER guidance agenda below.
Guidance Documents CBER is Planning to Publish Calendar Year 2026
This is the list of guidance topics CBER is considering for development during Calendar Year 2026
www.fda.gov
January 22, 2026 at 2:29 PM
CBER has outlined its 2026 guidance priorities, highlighting a strong focus on cell and gene therapy, CAR-T products, blood and blood components, and vaccines. The agenda offers early insight into evolving regulatory expectations for biologics.
Read the full CBER guidance agenda below.
Read the full CBER guidance agenda below.
What if cells could remember their past? Researchers have developed “TimeVaults,” engineered cellular structures that capture and store mRNA over time. This innovation may help explain cancer drug resistance, stem cell differentiation, and how prior cellular events shape future behavior.
A ‘time capsule’ for cells stores the secret experiences of their past
Scientists have transformed enigmatic cell structures, called vaults, into storage units for messenger RNA molecules.
www.nature.com
January 21, 2026 at 2:55 PM
What if cells could remember their past? Researchers have developed “TimeVaults,” engineered cellular structures that capture and store mRNA over time. This innovation may help explain cancer drug resistance, stem cell differentiation, and how prior cellular events shape future behavior.
The U.S. Food and Drug Administration is expanding use of real-world evidence by no longer requiring identifiable patient data in some device reviews, with possible updates for drugs to follow. The move unlocks large de-identified datasets.
📄 Read more here: www.fda.gov/news-events/...
#FDA #RWE
📄 Read more here: www.fda.gov/news-events/...
#FDA #RWE
January 15, 2026 at 10:03 PM
The U.S. Food and Drug Administration is expanding use of real-world evidence by no longer requiring identifiable patient data in some device reviews, with possible updates for drugs to follow. The move unlocks large de-identified datasets.
📄 Read more here: www.fda.gov/news-events/...
#FDA #RWE
📄 Read more here: www.fda.gov/news-events/...
#FDA #RWE
January is Cervical Health Awareness Month. Routine screening and HPV vaccination can help prevent cervical cancer and support earlier detection. Awareness is a powerful step toward better health outcomes. 🩵
#CervicalHealthAwarenessMonth #WomensHealth #PreventCancer
#CervicalHealthAwarenessMonth #WomensHealth #PreventCancer
January 12, 2026 at 7:00 PM
January is Cervical Health Awareness Month. Routine screening and HPV vaccination can help prevent cervical cancer and support earlier detection. Awareness is a powerful step toward better health outcomes. 🩵
#CervicalHealthAwarenessMonth #WomensHealth #PreventCancer
#CervicalHealthAwarenessMonth #WomensHealth #PreventCancer
Happy New Year! 🎉 Here’s to a 2026 filled with new beginnings, big ideas, and bright moments. Wishing you all the best from everyone at Thera-Business! ✨
#HappyNewYear #Welcome2026
#HappyNewYear #Welcome2026
January 1, 2026 at 3:58 PM
Happy New Year! 🎉 Here’s to a 2026 filled with new beginnings, big ideas, and bright moments. Wishing you all the best from everyone at Thera-Business! ✨
#HappyNewYear #Welcome2026
#HappyNewYear #Welcome2026
EU lawmakers agree on a major rewrite of pharma rules, reshaping data and market exclusivity, speeding reviews and addressing drug shortages. Industry groups welcome faster approvals but warn incentives may fall short on competitiveness.
📰 Read more here:
#EUPharma #LifeSciences #PharmaPolicy
📰 Read more here:
#EUPharma #LifeSciences #PharmaPolicy
European legislators reach agreement on sweeping overhaul to pharma policies
European legislators have reached a deal on a major rewrite of the region's pharma policies, pushing forward a framework aimed at boosting the bloc's competitiveness while strengthening supply chai | ...
www.fiercepharma.com
December 30, 2025 at 10:22 PM
EU lawmakers agree on a major rewrite of pharma rules, reshaping data and market exclusivity, speeding reviews and addressing drug shortages. Industry groups welcome faster approvals but warn incentives may fall short on competitiveness.
📰 Read more here:
#EUPharma #LifeSciences #PharmaPolicy
📰 Read more here:
#EUPharma #LifeSciences #PharmaPolicy
Christmas greetings to all who are celebrating!🎄🎁 Wishing you a joyful, cozy, and relaxing holiday season.✨🎅
#MerryChristmas #HappyHolidays
#MerryChristmas #HappyHolidays
December 25, 2025 at 9:22 PM
Christmas greetings to all who are celebrating!🎄🎁 Wishing you a joyful, cozy, and relaxing holiday season.✨🎅
#MerryChristmas #HappyHolidays
#MerryChristmas #HappyHolidays
Wishing you peace, joy, and celebration this holiday season! ✨
We’re grateful for your support and collaboration this year. Happy Holidays from our team to yours! 🎉
#HappyHolidays #SeasonsGreetings
We’re grateful for your support and collaboration this year. Happy Holidays from our team to yours! 🎉
#HappyHolidays #SeasonsGreetings
December 24, 2025 at 5:22 PM
Wishing you peace, joy, and celebration this holiday season! ✨
We’re grateful for your support and collaboration this year. Happy Holidays from our team to yours! 🎉
#HappyHolidays #SeasonsGreetings
We’re grateful for your support and collaboration this year. Happy Holidays from our team to yours! 🎉
#HappyHolidays #SeasonsGreetings
FDA approves Augmentin XR under the Commissioner’s National Priority Voucher (CNPV) pilot program—the first approval through this pathway—with review completed in just 2 months, significantly accelerating timelines for priority antibiotic therapies.
#FDA #DrugApproval #Antibiotics #PublicHealth
#FDA #DrugApproval #Antibiotics #PublicHealth
First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity
The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approva...
www.fda.gov
December 22, 2025 at 10:02 PM
FDA approves Augmentin XR under the Commissioner’s National Priority Voucher (CNPV) pilot program—the first approval through this pathway—with review completed in just 2 months, significantly accelerating timelines for priority antibiotic therapies.
#FDA #DrugApproval #Antibiotics #PublicHealth
#FDA #DrugApproval #Antibiotics #PublicHealth
The FDA launches the TEMPO pilot under the ACCESS Model, giving ~40 chronic-care devices enforcement discretion before clearance. Goal: real-world evidence to speed innovation in metabolic, musculoskeletal and behavioral health care.
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
December 18, 2025 at 7:48 PM
The FDA launches the TEMPO pilot under the ACCESS Model, giving ~40 chronic-care devices enforcement discretion before clearance. Goal: real-world evidence to speed innovation in metabolic, musculoskeletal and behavioral health care.
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
🔗 Read more here: www.fiercehealthcare.com/health-tech/...
Wishing a joyful and meaningful Hanukkah to all who celebrate! May this Festival of Lights bring warmth, reflection, and peace to you and your loved ones. ✨
#Hanukkah #FestivalOfLights
#Hanukkah #FestivalOfLights
December 15, 2025 at 8:15 PM
Wishing a joyful and meaningful Hanukkah to all who celebrate! May this Festival of Lights bring warmth, reflection, and peace to you and your loved ones. ✨
#Hanukkah #FestivalOfLights
#Hanukkah #FestivalOfLights
The @fda.gov has released draft guidance on Quality Management System info for certain PMA submissions, ahead of the QMSR rule taking effect in Feb 2026. Comments are open until Jan 16, 2026.
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
December 11, 2025 at 7:58 PM
The @fda.gov has released draft guidance on Quality Management System info for certain PMA submissions, ahead of the QMSR rule taking effect in Feb 2026. Comments are open until Jan 16, 2026.
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
🔗 Draft guidance: www.fda.gov/regulatory-i...
#FDA #MedicalDevices #QMSR #RegulatoryUpdates
December 10th is #HumanRightsDay. Today, we are reminded that dignity, freedom, and justice are everyday essentials.
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
December 10, 2025 at 9:51 PM
December 10th is #HumanRightsDay. Today, we are reminded that dignity, freedom, and justice are everyday essentials.
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
Let’s work toward a world where human rights are upheld for everyone.
🔗 Learn more: www.un.org/en/observanc...
#UDHR #RightsMatter
Today, on the National Day of Remembrance and Action on Violence Against Women, we honour the 14 women killed at École Polytechnique in 1989. As part of the #16Days of Activism, we recommit to ending gender-based violence.
#December6 #EndGBV #WhiteRibbon
#December6 #EndGBV #WhiteRibbon
December 7, 2025 at 9:41 PM
Today, on the National Day of Remembrance and Action on Violence Against Women, we honour the 14 women killed at École Polytechnique in 1989. As part of the #16Days of Activism, we recommit to ending gender-based violence.
#December6 #EndGBV #WhiteRibbon
#December6 #EndGBV #WhiteRibbon
Fierce Pharma’s 2025 Fiercest Women in Life Sciences celebrates women leading innovation across pharma & biotech.
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
December 5, 2025 at 5:15 PM
Fierce Pharma’s 2025 Fiercest Women in Life Sciences celebrates women leading innovation across pharma & biotech.
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
Read about the impact, insight, and inspiration these leaders bring to the field.
🔗 www.fiercepharma.com/pharma/2025s...
#FierceWomen #LifeSciences #STEMLeadership
The Top 5 CNN Heroes of 2025 have been announced — five everyday people doing extraordinary good. 💛
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
December 3, 2025 at 2:27 PM
The Top 5 CNN Heroes of 2025 have been announced — five everyday people doing extraordinary good. 💛
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
The Thera-Business will be voting and supporting these inspiring nonprofits.
Read about each person and cast your vote at www.cnn.com/world/heroes and help uplift changemakers.
#CNNHeroes
On this #GivingTuesday, we’re proud to support those advancing equity, access, and better health. Today, our team is taking time to recognize the organizations that inspire us and make a meaningful difference in the communities they serve. 💙
#GivingTuesday2025 #HealthEquity #Impact
#GivingTuesday2025 #HealthEquity #Impact
December 2, 2025 at 4:10 PM
On this #GivingTuesday, we’re proud to support those advancing equity, access, and better health. Today, our team is taking time to recognize the organizations that inspire us and make a meaningful difference in the communities they serve. 💙
#GivingTuesday2025 #HealthEquity #Impact
#GivingTuesday2025 #HealthEquity #Impact