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BIO Files Amicus Brief Urging Harmonization of Federal Court Frameworks for Determining Patent Obviousness in Patent Litigation
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Amicus Brief  •  October 16, 2020
BIO filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit on an important and recurring question concerning the framework for determining patent obviousness in patent litigation. BIO argues that courts, when considering whether a patent meets the statutory “nonobviousness” requirement, should consider all evidence for and against the patent’s validity together at the same time. Courts should not use only part of the evidence to conclude that the patent is invalid and then shift the burden to the patent owner.
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FDA approved the first drug to treat Ebola
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Good Day BIO Newsletter  •  October 16, 2020
BREAKING NEWS: The Wall Street Journal reports that Pfizer could apply for emergency use of a COVID-19 vaccine by late November. Pfizer CEO Albert Bourla published an open letter to speak directly to the public about the company's plans.In other news, the FDA approved the first drug to treat Ebola virus, which is a major breakthrough as Ebola continues to spread. We have details, plus what former VP Joe Biden said about carbon capture and renewable energy, in around 770 words, just under 4 minutes.
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Investment and innovation are booming, but…
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Good Day BIO Newsletter  •  October 15, 2020
Day 2 of BIO Investor Forum Digital brought insights into how the FDA is handling the pandemic, the outlook for biotech markets and drug pricing policy, and practical advice on how to improve diversity and inclusion. As usual, Washington news at the end. Here are around 1,000 words, 5 minutes.
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Biotech VC, by the numbers
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Good Day BIO Newsletter  •  October 14, 2020
We recap a fantastic first day of BIO Investor Forum Digital, with a look at VC investment trends, the latest news from the AMR Action Fund, and why diversity matters in clinical trials and in companies. It's all below, plus your usual news from Washington, in just under 1,000 words, just under 5 minutes.
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What are biotech investors thinking?
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Good Day BIO Newsletter  •  October 13, 2020
BIO Investor Forum Digital begins today—and we give you a sneak peek at what you’ll hear from both investors and emerging companies, as well as tell you how to follow along. We also take a closer look at COVID-19 and the world’s plastic problem and what’s happening in Washington. Here are around 785 words, just under 4 minutes.
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The golden age of medicine
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Good Day BIO Newsletter  •  October 12, 2020
BIO Investor Forum Digital kicks off tomorrow—and to get ready, Dr. Michelle talks to a biotech investor about everything from COVID-19 therapeutics and diagnostics to the impact of drug pricing policy on investors’ decision-making. Also, POET explains how biofuels can help farmers and the environment. Here are around 840 words, just over 4 minutes.
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Breakthrough drugs are no accident
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Good Day BIO Newsletter  •  October 9, 2020
There’s been a lot of chatter about breakthrough coronavirus treatments this week—so today, we tell you how novel therapies come about in the United States. (No, it’s not magic.) And since we’re still excited about the Nobel Prize for Chemistry, we take a look at CRISPR’s potential in industrial biotech and biofuels. Here are 830 words, 4 minutes.
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Let’s help patients, not PBMs
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Good Day BIO Newsletter  •  October 8, 2020
Today, we dig into the SCOTUS case addressing pharmacy benefit managers, and explain why we need to fix this system. Also, meet the winners of the Nobel Prize in Chemistry and learn why their technology is so important to human, animal, and environmental health. Here’s your Thursday news in 900 words, 4 and a half minutes.
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FDA releases COVID-19 vaccine guidance
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Good Day BIO Newsletter  •  October 7, 2020
Days after we sent a letter about it to the Trump administration, the U.S. Food and Drug Administration (FDA) released new guidance related to COVID-19 vaccines, bringing clarity to scientists and strengthening public confidence in the process. We have details, plus a look at two BIO members collaborating to develop biofuels and biochemicals, in around 711 words, 3 and a half minutes.
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BIO’s Dr. McMurry-Heath Applauds FDA Release of Guidance for Covid-19 Vaccines
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Press Release  •  October 6, 2020
Dr. Michelle McMurry-Heath, the president and CEO of the Biotechnology Innovation Organization (BIO), today applauded the Food and Drug Administration (FDA) for publicly releasing new guidance related to the emergency use authorization of future Covid-19 vaccines. The FDA’s action came just days after Dr. McMurry-Heath called on U.S. Health & Human Services Secretary Alex Azar to release the guidance in order to help those developing a vaccine and to promote greater public confidence in future Covid-19 vaccines. Dr. McMurry-Heath released the following statement: “In the midst of a pandemic, transparency and collaboration are critical if we are going to quickly and safely eradicate this global health threat. That is why we recently called for the public release of any new FDA guidance concerning emergency use authorization for Covid-19 vaccines. The release of this information is vital for the scientists and researchers working on the frontlines combating this pandemic, as well as for building public confidence in the scientific solutions our industry is committed to delivering. “We applaud the FDA for following their tried and true tradition of releasing their guidance in a public and transparent way. Science should stand on its own. While we are still reviewing the details, this is an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people’s trust in any future vaccines. We look forward to ongoing communication with the independent experts at the FDA to further clarify the steps needed to bring a safe and effective vaccine to the American public.”
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