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Announcement! Olympian and Grand Slam Champ Venus Williams and Emmy-nominated sportscaster Erin Andrews will headline BIO International Convention and share their patient perspectives—only in San Diego! Get the details and register. In today’s news: a recap of yesterday’s House markup of FDA user fee reauthorization, Mental Health Action Day, and Dr. Michelle’s take on SAF. (663 words, 3 minutes, 18 seconds) |
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House committee advances FDA user fees, accelerated approval changes |
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The full House Energy & Commerce Committee yesterday marked up six health-related bills, including reauthorization of the FDA user fee agreements—here’s what happened. What happened: The House Energy & Commerce Committee voted unanimously (55-0) to advance the FDA user fee reauthorization legislation, which the Health Subcommittee marked up last week. The bill, Food and Drug Amendments of 2022, includes accelerated approval reforms and provisions to improve clinical trial diversity.
What it will do: The legislation would “improve FDA’s review of drugs, biologics, and medical devices,” said Chair Frank Pallone (D-NJ). “The bill will also reduce drug costs, improve program integrity and oversight in the accelerated approval program, and improve diverse representation in clinical studies.”
About accelerated approval…The bill “would strengthen the FDA’s power to ensure there are clear conditions for completing confirmatory trials and gives regulators the authority to require studies to be underway before approval is granted,” Axios reported last week.
What they’re saying: “The accelerated approval pathway is key to innovation and making sure innovators have certainty in their application process, and is a good policy,” said Rep. Larry Bucshon, M.D. (R-IL).
Watch more highlights from the markup.
The next steps: The Senate released its version of the FDA user fee reauthorization earlier this week, which notably “does not address either accelerated approval reforms or clinical trial diversity,” reports Endpoints News. |
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BIO CEO: ‘The future of green air travel is here’ |
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With air travel “rapidly returning to pre-pandemic norms,” we need to refocus on reducing the industry’s emissions. Luckily, sustainable aviation fuel is already here, writes BIO’s Dr. Michelle McMurry-Heath in the Seattle Times. Why sustainable aviation fuel? SAF can “generate up to 80% fewer carbon emissions than kerosene,” writes BIO’s President and CEO Dr. Michelle McMurry-Heath. “SAFs can be used in any aircraft that currently burns jet fuel, without modification to the engine or plane.”
It’s already taking off—with United Airlines carrying 100 passengers on the first flight powered solely by SAF (and BIO member company Virent).
“But limited supply has hindered adoption, such that SAFs currently account for only 0.01% of global jet fuel use,” she continues.
“That’s poised to change," she explains. "In September, the Biden administration set an ambitious goal of replacing all jet fuel with sustainable alternatives by 2050. In response, biotech companies are partnering with airlines and others to scale up production of biofuels.”
Read and share the whole thing. |
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Mental Health Action Day is a call for connection |
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Today is Mental Health Action Day—and this year’s theme, Connection, focuses on how we can take action against the loneliness and isolation of the pandemic.
By the numbers: The global incidence of anxiety and depression jumped 25% in the first year of COVID-19, per the World Health Organization (WHO). And the CDC found lockdowns, remote schooling, and isolation during the pandemic had a significant impact on the mental health of teenagers.
“The last two years have brought to light mental health challenges and made it easier to talk about them,” Erika Soto Lamb of MTV Entertainment Group, one of the organizers of Mental Health Action Day, told Bloomberg. “But there is still so much work to do to help people take actions to address them.”
Mental Health Action Day aims to shift from awareness to action—this year, focusing on providing resources for coping with loneliness and isolation.
We’re coming together for mental health. May is Mental Health Awareness Month. All month long, the National Alliance on Mental Illness (NAMI) will continue to provide support, educate the public, and advocate for policies that support people with mental illness and their families, focused on the theme “Together for Mental Health.” |
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| Nikon's New Confocal Microscopes
| Nikon’s AX/AX R Confocal Microscopes combine optical enhancements with advanced AI-based tools designed to dramatically improve usability. The industry-leading 25 mm field of view enables faster data acquisition with unprecedented detail and ease. BIO members get exclusive discounts.
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