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340B transparency bill advances
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Bio.News  •  May 25, 2023
A busy pre-holiday Thursday, with activity on 340B in the House yesterday and a look at why Congress must repeal the R&D amortization provision. Plus, BIO just announced a new keynote speaker at the BIO International Convention—we have the details. (665 words, 3 minutes, 19 seconds)
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FDA Commissioner Dr. Robert Califf to Address Medical Misinformation During Keynote Address at BIO International Convention
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Press Release  •  May 25, 2023
BIO CEO Rachel King and Califf will discuss issues impacting FDA and the biotech communityWASHINGTON - (May 25, 2023) – Robert Califf, commissioner of the Food and Drug Administration, will be the keynote speaker on day three of the 2023 BIO International Convention. In a wide-ranging interview on June 7, hosted by Rachel King, CEO of the Biotechnology Innovation Organization (BIO), Califf will discuss the public health consequences of misinformation, threats to FDA’s authority in determining drug safety and efficacy, the pandemic response, the impact of the Inflation Reduction Act, the importance of diversity, equity, and inclusion in biotech, the consequences of health disparities, and more. The BIO International Convention will take place at the Boston Convention and Exhibition Center from June 5 – 8. “Scientific facts and data are at the heart of what we do in the biotech industry,” said King. “We are so pleased that Dr. Califf is joining us, as we Stand Up For Science and fight back against distortions and half-truths that can spread like wildfire in the age of social media. I look forward to discussing this and the myriad of issues facing our industry and the FDA.”  Califf returned to lead the FDA as the 25th commissioner in 2022, having served as the 22nd commissioner in 2016. During his latest tenure as FDA commissioner, he’s weathered a pandemic, attacks on the accelerated approval pathway, and an infant formula shortage. Califf has made fighting misinformation a top priority, citing its spread as a contributing factor to a drop in life expectancy in the U.S. In a recent episode of the I am BIO podcast on misinformation Califf said, “I am deeply concerned and passionate about the issue of misinformation, because it kills people. When we look across the whole spectrum of medicine and how many great technologies we now have that can extend useful life, it's essential that we get truthful, reliable information to people. The purveyors…
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BIO Office Hours: FDA Inspections with PSC Biotech
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May 24, 2023
How do you prepare for an upcoming regulatory inspection? Do fully understand the FDA inspection procedures? What are the steps following inspection close? Ask a PSC Inspection Management Expert during BIO’s Office Hours.   Schedule Office Hour  
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Are PBMs working in the interest of health care?
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Bio.News  •  May 24, 2023
Could PBMs provide the bipartisanship we need? Yesterday’s House hearing made us think so. Plus, researchers asked 100 questions facing plant science—and biotech has some answers. (626 words, 3 minutes, 7 seconds)
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How Boston became a 'biotech hub'
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Bio.News  •  May 23, 2023
A bonus episode of the I am BIO Podcast explores how Boston became a biotech hub—and how you can get in on the action. Plus, climate change is affecting our sleep in more ways than one—here’s what biotech can do about it. (632 words, 3 minutes, 9 seconds)
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Why are Katie Couric and 15K People Headed to Boston?
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I am BIO Podcast  •  May 23, 2023
During the last several decades Boston has become a biotech Mecca, with its Kendall Square attracting more than 120 biotech companies, both large and small. It is called the most innovative square mile on the planet.  This June BIO will bring over 15,000 biotech leaders to Boston for its 2023 BIO International Convention. Speakers including award-winning journalist and health advocate, Katie Couric, will talk about how they will “Stand up for Science”—the Convention’s theme. MassBIO CEO, Kendalle Burlin O’Connell joins host, Rachel King in a wide-ranging discussion about how Boston became the largest biotech hub in the world.
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This partnership aims to accelerate gene therapy
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Bio.News  •  May 22, 2023
A public-private partnership, led by the Foundation for the National Institutes of Health (NIH), announced eight rare diseases for a clinical trial portfolio that will help accelerate gene therapies. Plus, the World Organization for Animal Health’s 90th general session opens with a focus on avian flu. (678 words, 3 minutes, 23 seconds)
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New weather data highlights need for biotech, ASAP
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Bio.News  •  May 19, 2023
The bad news: The planet’s almost definitely getting hotter. The better news: Biotech has solutions to address the impact and curb future emissions. Plus, news on a groundbreaking menopause treatment, ARPA-H, and the RSV vaccine race. (545 words, 2 minutes, 43 seconds)
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PBM and 340B bills advance in House
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Bio.News  •  May 18, 2023
Today, we have a recap of hearings and a markup on Capitol Hill, which advanced important PBM and 340B legislation, among other bills. Plus, it’s Global Accessibility Awareness Day—we tell you why it matters and how you can be a better advocate. (840 words, 4 minutes, 12 seconds)
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Who owns AI-assisted inventions?
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Bio.News  •  May 17, 2023
Today, what BIO told the U.S. Patent & Trademark Office about AI, and why crops need to worry about superbugs, too. (614 words, 3 minutes, 4 seconds)
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