Yale CRRIT
@yalecrrit.bsky.social
The Collaboration for Regulatory Rigor, Integrity, & Transparency (CRRIT), based out of Yale Medical, Public Health, & Law schools, researches the regulation, approval, & coverage of medical drugs & devices to advance policies that improve patient health.
Read the full article: jamanetwork.com/journals/jam... (7/7)
Venture Capital Investments by Academic Medical Centers in Health Care Companies
This cross-sectional study investigates how US academic medical centers used their own venture capital funds to invest in early-stage health care companies from 2014 to 2024.
jamanetwork.com
November 11, 2025 at 5:25 PM
Read the full article: jamanetwork.com/journals/jam... (7/7)
This team was comprised of Emory School of Medicine student Ravi Dhawan, @hsph.harvard.edu Denys Shay, @emoryrollins.bsky.social student Anna Leland, CRRIT Co-Directors @reshmagar.bsky.social and @jsross119.bsky.social, and @emoryrollins.bsky.social Joshua Wallach. (6/7)
November 11, 2025 at 5:25 PM
This team was comprised of Emory School of Medicine student Ravi Dhawan, @hsph.harvard.edu Denys Shay, @emoryrollins.bsky.social student Anna Leland, CRRIT Co-Directors @reshmagar.bsky.social and @jsross119.bsky.social, and @emoryrollins.bsky.social Joshua Wallach. (6/7)
Investments declined in 2022-2023. However, this reflected patterns of higher inflation and borrowing costs in the market. Our study was also discussed in a @jamainternalmed.com editorial: jamanetwork.com/journals/jam... (5/7)
When Academic Medical Centers Invest in Bringing Their Research to Market
Academic medical centers (AMCs) are facing difficult financial times, with funding uncertainty from the National Institutes of Health (NIH) and other federal agencies and concerns over potential reduc...
jamanetwork.com
November 11, 2025 at 5:25 PM
Investments declined in 2022-2023. However, this reflected patterns of higher inflation and borrowing costs in the market. Our study was also discussed in a @jamainternalmed.com editorial: jamanetwork.com/journals/jam... (5/7)
These findings reflect the continued trend of increased financialization of healthcare. Additionally, this also shows AMCs’ interest in investing in internally developed scientific advancements. (4/7)
November 11, 2025 at 5:25 PM
These findings reflect the continued trend of increased financialization of healthcare. Additionally, this also shows AMCs’ interest in investing in internally developed scientific advancements. (4/7)
Key findings: AMCs are using venture capital funds to invest in early-stage companies, with total investments doubling between 2014 and 2024. 110 AMCs made 880 investments in 693 healthcare companies between 2014 and2024 which, totaled $24.2 billion (3/7)
November 11, 2025 at 5:25 PM
Key findings: AMCs are using venture capital funds to invest in early-stage companies, with total investments doubling between 2014 and 2024. 110 AMCs made 880 investments in 693 healthcare companies between 2014 and2024 which, totaled $24.2 billion (3/7)
AMCs are using VC funds to invest in healthcare companies, allowing increased control over the development of innovations and facilitation of external commercialization to increase revenue (2/7)
November 11, 2025 at 5:25 PM
AMCs are using VC funds to invest in healthcare companies, allowing increased control over the development of innovations and facilitation of external commercialization to increase revenue (2/7)
Full story: www.statnews.com/2025/10/29/f... (3/3)
FDA moves to ease path for biosimilars as Trump seeks to cut drug costs
The FDA is aiming to make it easier to get biosimilar drugs approved.
www.statnews.com
November 4, 2025 at 2:05 PM
Full story: www.statnews.com/2025/10/29/f... (3/3)
CRRIT Co-Director @reshmagar.bsky.social told @ STAT News that “this is a good thing and aligns with other regulatory agencies like the European Medicines Agency”. However, more needs to be done regarding access and affordability, specifically “reimbursement and patents” (2/3)
November 4, 2025 at 2:05 PM
CRRIT Co-Director @reshmagar.bsky.social told @ STAT News that “this is a good thing and aligns with other regulatory agencies like the European Medicines Agency”. However, more needs to be done regarding access and affordability, specifically “reimbursement and patents” (2/3)
This team was comprised of @yaleschoolofmed.bsky.social student Carla Godoy, CRRIT Co-Director @reshmagar.bsky.social, Yale College alumnus Pradyumna Sapre, and CRRIT Co-Director @jsross119.bsky.social (8/8)
Full article: journals.sagepub.com/doi/10.1177/...
Full article: journals.sagepub.com/doi/10.1177/...
Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023 - Carla Barile Godoy, Reshma Ramachandran, Pradyumna Sapre, Joseph S Ros...
Backgrounds/Aims: To secure market authorization, the Food and Drug Administration requires that drug manufacturers demonstrate product safety and efficacy for ...
journals.sagepub.com
November 3, 2025 at 6:35 PM
This team was comprised of @yaleschoolofmed.bsky.social student Carla Godoy, CRRIT Co-Director @reshmagar.bsky.social, Yale College alumnus Pradyumna Sapre, and CRRIT Co-Director @jsross119.bsky.social (8/8)
Full article: journals.sagepub.com/doi/10.1177/...
Full article: journals.sagepub.com/doi/10.1177/...
Given increased use of single pivotal trials supporting FDA approval of new drugs & biologics, our study findings indicate a need for greater clarity & transparency by reviewers & sponsors on what evidence was considered to be confirmatory when approving drugs based on a single pivotal trial (7/8)
November 3, 2025 at 6:35 PM
Given increased use of single pivotal trials supporting FDA approval of new drugs & biologics, our study findings indicate a need for greater clarity & transparency by reviewers & sponsors on what evidence was considered to be confirmatory when approving drugs based on a single pivotal trial (7/8)
185 (42%) were based on a single pivotal trial. FDA explicitly referenced confirmatory evidence for 36 (19.5%) single pivotal trial approvals and implicitly referenced confirmatory evidence for 4 (2.2%). (6/8)
November 3, 2025 at 6:35 PM
185 (42%) were based on a single pivotal trial. FDA explicitly referenced confirmatory evidence for 36 (19.5%) single pivotal trial approvals and implicitly referenced confirmatory evidence for 4 (2.2%). (6/8)
Key findings: 441 original drug and biologics indications were approved between 2015 and 2023, 181 (41%) were based on 2 or more pivotal trials, 35 (7.9%) were based on a single pivotal trial with at least one clinical primary efficacy endpoint without orphan designation (5/8)
November 3, 2025 at 6:35 PM
Key findings: 441 original drug and biologics indications were approved between 2015 and 2023, 181 (41%) were based on 2 or more pivotal trials, 35 (7.9%) were based on a single pivotal trial with at least one clinical primary efficacy endpoint without orphan designation (5/8)
Long story, short: We found that looking at years of new drug and biologic approvals, that just over half were based on single pivotal trials and only a few explicitly or implicitly referenced confirmatory evidence supporting that single pivotal trial. (4/8)
November 3, 2025 at 6:35 PM
Long story, short: We found that looking at years of new drug and biologic approvals, that just over half were based on single pivotal trials and only a few explicitly or implicitly referenced confirmatory evidence supporting that single pivotal trial. (4/8)
In 2024, 66% of all new drug and biologic approvals were based on 1 pivotal trial. www.agencyiq.com/blog/analysi... (3/8)
Analysis: The majority of novel drugs approved by FDA rely on evidence from a single pivotal trial | AgencyIQ by POLITICO
An analysis by AgencyIQ shows that the FDA is increasingly relying upon evidence obtained from a single pivotal study to demonstrate the safety and efficacy ...
www.agencyiq.com
November 3, 2025 at 6:35 PM
In 2024, 66% of all new drug and biologic approvals were based on 1 pivotal trial. www.agencyiq.com/blog/analysi... (3/8)
@fda.gov typically required 2 or more pivotal trials to demonstrate “substantial evidence of effectiveness”, but later allowed for 1 along with confirmatory evidence such as animal studies, RWE, natural history data, & more. (2/8)
Analysis: The majority of novel drugs approved by FDA rely on evidence from a single pivotal trial | AgencyIQ by POLITICO
An analysis by AgencyIQ shows that the FDA is increasingly relying upon evidence obtained from a single pivotal study to demonstrate the safety and efficacy ...
www.agencyiq.com
November 3, 2025 at 6:35 PM
@fda.gov typically required 2 or more pivotal trials to demonstrate “substantial evidence of effectiveness”, but later allowed for 1 along with confirmatory evidence such as animal studies, RWE, natural history data, & more. (2/8)
Watch the full hearing including Dr. Ramachandran’s testimony here: www.help.senate.gov/hearings/the... (5/5)
November 1, 2025 at 11:15 PM
Watch the full hearing including Dr. Ramachandran’s testimony here: www.help.senate.gov/hearings/the... (5/5)
www.help.senate.gov
November 1, 2025 at 11:15 PM
In her written testimony, she further elaborates on specific solutions that Congress and agencies like the @fda.gov can employ to ensure a “Future for Biotech” that “aligns stated principles with actions that deliver not just more cures, but those that are truly safe, effective, & accessible” (3/5)
November 1, 2025 at 11:15 PM
In her written testimony, she further elaborates on specific solutions that Congress and agencies like the @fda.gov can employ to ensure a “Future for Biotech” that “aligns stated principles with actions that deliver not just more cures, but those that are truly safe, effective, & accessible” (3/5)
CRRIT Co-Director @reshmagar.bsky.social discussed challenges at @fda.gov and other agencies hindering the delivery of safe, effective & affordable drugs at the Senate HELP Committee hearing, "The Future of Biotech: Maintaining US Competitiveness and Delivering Lifesaving Cures to Patients” (2/5)
November 1, 2025 at 11:15 PM
CRRIT Co-Director @reshmagar.bsky.social discussed challenges at @fda.gov and other agencies hindering the delivery of safe, effective & affordable drugs at the Senate HELP Committee hearing, "The Future of Biotech: Maintaining US Competitiveness and Delivering Lifesaving Cures to Patients” (2/5)
This team was comprised of @yaleschoolofmed.bsky.social Tiffany Jiang, CRRIT Co-Director @reshmagar.bsky.social, University of Zurich Kerstin Vokinger & CRRIT Co-Director @jsross119.bsky.social (3/3)
Full article: www.tandfonline.com/doi/full/10....
Full article: www.tandfonline.com/doi/full/10....
Therapeutic benefit of the most expensive drugs covered by Medicare and Medicaid
The United States began drug pricing negotiations in 2024 under the Inflation Reduction Act. Evaluating the therapeutic benefit of drugs will help guide pricing decisions and are an opportunity to ...
www.tandfonline.com
October 24, 2025 at 1:57 PM
This team was comprised of @yaleschoolofmed.bsky.social Tiffany Jiang, CRRIT Co-Director @reshmagar.bsky.social, University of Zurich Kerstin Vokinger & CRRIT Co-Director @jsross119.bsky.social (3/3)
Full article: www.tandfonline.com/doi/full/10....
Full article: www.tandfonline.com/doi/full/10....
Key findings: 50 of the most expensive drugs in 2022 covered by Medicare and Medicaid were evaluated, over 50% were rated by French & German HTAs as having low therapeutic benefit, six were rated as “not acceptable” or “to avoid” (2/3)
October 24, 2025 at 1:57 PM
Key findings: 50 of the most expensive drugs in 2022 covered by Medicare and Medicaid were evaluated, over 50% were rated by French & German HTAs as having low therapeutic benefit, six were rated as “not acceptable” or “to avoid” (2/3)