|
|
|
BIO sets the record straight on accelerated approval—and experts answer YOUR questions about biotech, from how personalized medicine is shaping care to what makes startups attractive to investors. (641 words, 3 minutes, 12 seconds) |
|
|
|
|
|
|
Setting the record straight on accelerated approval |
|
|
Accelerated approval “has successfully sped up the development of new medicines for people with life-threatening conditions and few treatment options,” says BIO in a Bio.News editorial refuting a misleading critique.
Accelerated approval “relies on surrogate endpoints that can reasonably predict whether a treatment will result in clinical benefit, such as tumor shrinkage or a lab result,” explains BIO.
A misleading study “claims that nearly half of cancer medicines granted accelerated approval lack clinical benefit because they don’t improve overall survival. Recent commentary and new research demonstrate why this assertion is wrong,” says BIO.
Why it matters: “A lack of data on whether a drug has extended lives is different than proving it doesn’t extend lives,” says BIO, citing BioCentury’s Steve Usdin. Furthermore, the “practical—and ethical—challenges of studying overall survival” mean the FDA does not always require survival to prove medical benefit.
Extending life:A study of 69 cancer therapies receiving accelerated approval found “earlier access to the treatments added roughly 263,000 life years across 911,000 cancer patients.”
Helping disadvantaged communities: “A new Avalere analysis found accelerated approval helps Medicare beneficiaries in underserved communities gain access to life-changing medicines.”
The bottom line: “The facts clearly show the accelerated approval pathway is providing new hope and meaningful new treatments for patients to fight their disease, and why we shouldn’t be misled by biased studies that distort reality,” concludes BIO. Read and share the whole thing. More Health News: The New York Times: First patient begins newly approved sickle cell gene therapy
“The treatment helped patients in clinical trials, but Kendric [Cromer] is the first commercial patient for bluebird bio, a Somerville, Mass., company… Wednesday’s treatment was only the first step. Doctors removed his bone marrow stem cells, which bluebird will then genetically modify in a specialized lab for his treatment.” Read more from bluebird bio. |
|
|
|
|
Your biotech questions, answered |
|
|
The new episode of the I am BIO Podcast, released today, features experts answering listeners’ pressing biotech questions.
Q: Will agrigenomics let us feed the world and address climate change by 2050?
A: “Biotechnology has enabled a tremendous change toward soil health,” says Fred Yoder, Ohio farmer. CRISPR gene editing also makes seeds able to increase yields despite climate change: “These new genetics have been tremendous.”
Q: What makes startups attractive for acquisition?
A: “Networking is incredibly important, particularly for startups who need to know what they don't know and need to share what they do know,” says Bernard Fallon, BIO Deputy VP of Industry Programs, explaining how events like BIO 2024 enable networking.
Q: How is personalized medicine reshaping care?
A: Personalized medicine can “guide doctors' decisions in treatment” and “improve diagnosis and prevention,” says Dr. E'Lissa Flores, BIO Director of Science and Regulatory Affairs. “You could save so much cost in the long term, with reduced doctor and hospital visits.”
Q: How can we make consumers more accepting of GMOs in foods?
A: “The science that drives innovations like GMOs can often be misunderstood,” says Dr. Ray Dobert of Bayer Crop Science. “Find stories and analogies that broader audiences can understand so that they can relate to not just the products and how they're generated, but to the people who use them.” Listen at bio.org/podcast or wherever you get your podcasts. More Agriculture News: AgWeb: U.S. continues to assert Mexico’s ban on GMO corn for food lacks scientific basis
“The U.S. rebuttal on Mexico’s GMO corn ban for food use argues Mexico’s submission to the U.S.-Mexico-Canada Agreement (USMCA) panel contains factual and legal inaccuracies.” |
|
|
|
Are you a life science entrepreneur in the fields of therapeutics or diagnostics ready to build and hone your business model, product development plan and commercialization strategy? Are you gearing up for Seed or Series A funding?
California Life Sciences is now accepting applications for the Fall cohort of its bi-annual advisory program, FAST California. Early-stage startups creating disruptive technologies with high medical impact are invited to apply by July 1, 2024. Click here to learn more. |
|
|
|
|
|
|
|
|
|
