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BIO Joins Letter to FDA Commissioner on Clarifying Guidance for Plant Gene Editing
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Agriculture & Environment  •  Letters, Testimony & Comments  •  July 29, 2020
New innovations capable of advancing plant breeding, such as gene editing, have immense potential to improve agriculture and food production. Researchers are exploring genetic innovations aimed at increasing agricultural productivity; improving environmental sustainability outcomes; providing consumers safer and more nutritious products; and reducing food waste, among many other benefits. However, the future of many of these innovations relies on the existence of a science-based, risk-appropriate regulatory system – one that is consistent across domestic regulatory agencies and internationally – and does not impose unnecessary burdens to market access. FDA has a critical role to play in shaping this regulatory framework by clarifying the agency’s approach to plants derived from these new techniques under its 1992 guidance on Foods Derived from New Plant Varieties. To obtain an outcome that best supports regulatory consistency, we urge FDA to issue this clarifying guidance as expeditiously as possible.
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Making the case for small and emerging biotechs
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Bio.News  •  July 29, 2020
With so much talk in the news about “big pharma,” it’s important to remember the small companies driving innovation in our industry. So, today, we’re dedicating our issue to the small and emerging biotechs researching solutions for COVID-19 and other global challenges—and what the government needs to do to support them. Here are 725 words, around 3 and a half minutes.
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It’s 5 AM on the coronavirus vaccine clock
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Bio.News  •  July 28, 2020
As Moderna’s COVID-19 vaccine heads to Phase 3 clinical trials, USA Today has updated its “coronavirus clock” to give you an idea of when we might return to normal. We also explore new research on how to eliminate plastic waste—and how bioplastics are part of the solution. Here are 900 words, 4 and a half minutes.
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Join the BIO Member Diversity and Inclusion 2020 Survey
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2 things biotech investors need to know today
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Bio.News  •  July 27, 2020
Following the announcement of sweeping drug price controls on Friday, Trump's kicking off the week with a visit to a biotech company (and BIO member) working on a COVID-19 vaccine. We've got the details below. We also look at two important issues for biotech investors: racial diversity and the SEC's new rules on proxy firms. Here are around 850 words, or 4 minutes, 15 seconds.
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What you need to know about Trump's executive orders on drug pricing
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Bio.News  •  July 25, 2020
Yesterday, President Trump announced four potentially sweeping executive orders on prescription drug prices, including one that could impose foreign price controls that are more extreme than what the administration has proposed in the past. In this special Saturday edition of Good Day BIO, we take a look at what's in the executive orders and what you can expect to happen next, in about 540 words, under 3 minutes.
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What you need to know about Trump's executive orders on drug pricing
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Bio.News  •  July 25, 2020
Yesterday, President Trump announced four potentially sweeping executive orders on prescription drug prices, including one that could impose foreign price controls that are more extreme than what the administration has proposed in the past. In this special Saturday edition of Good Day BIO, we take a look at what's in the executive orders and what you can expect to happen next, in about 540 words, under 3 minutes.
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BIO’s Dr. McMurry-Heath Warns Executive Order to “Cripple Small, Innovative Companies” Working to Eradicate COVID-19
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Press Release  •  July 24, 2020
Says biopharma researchers and scientists stand ready to support real solutions that will address patient drug costs, continue lifesaving science Dr. Michelle McMurry-Heath, the president and CEO of the Biotechnology Innovation Organization (BIO), released a statement today warning that an executive order to adopt foreign price controls on certain prescription medicines could “cripple” companies working to eradicate COVID-19 and lead to less patient access to lifesaving treatments. Dr. McMurry-Heath raised these and other concerns in a letter to President Trump, which urged the president to abandon any further implementation of the executive order imposing foreign price controls. Her full statement is below: “As the pandemic continues to worsen in the U.S., hitting more and more communities, the administration should be focused on doing everything it can to support those on the frontlines working to save lives, get our kids back to school and our economy back on track. While we strongly support today’s action to help reform a broken rebate system and ensure savings provided by drugmakers are passed along to patients, adopting foreign price controls by executive fiat will cripple the small, innovative companies developing the vaccines and therapies that will help end this pandemic and get the American people back to work.  "All across the country, there are scientists and researchers in our labs working day and night to end the COVID-19 pandemic. They are trying desperately to develop the scientific solutions we need to eradicate this devastating public health crisis. We will not overcome this pandemic or future ones if we seek short-sighted polices that adopt foreign price controls from systems that don’t value innovation, disrupt providers’ ability to deliver care and increase barriers to patient access. There is a reason that over half of all the science and drug development related to COVID-19 is coming from the U.S. “It is ironic, but perhaps not…
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Trump’s foreign drug price controls return
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Bio.News  •  July 24, 2020
We’re starting the weekend with a win for BIO members: The Securities and Exchange Commission (SEC) voted to regulate proxy advisers more closely, meaning members will be able to fight back against corporate activists. We’ll dig into this more on Monday. In the meantime, we have breaking news on Trump’s plans to announce foreign price controls for prescription drugs, as well as a refresher on the Americans with Disabilities Act (ADA) ahead of the law’s 30th anniversary. And, since we’re at just about 100 days until the election, we have a special election update at the end. We’re clocking in at about 1,000 words, or 5 minutes.
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No, Americans don’t pay twice for new medicines
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Bio.News  •  July 23, 2020
Now more than ever, we need to support biotech innovators—helping them find investors and strategic partners to advance their company to the next stage in their business life cycle. From October 13-15, BIO Investor Forum Digital will create a venue—entirely online—to support investment deal flow and help small biotechs find the capital and strategic partners to succeed in their next stage of growth. Click here for details and registration.  Today, we dive into a new study on public research funding and drug prices, as well as the EPA’s announcement on airline emissions. Here are around 800 words, 4 minutes.
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