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New SEC rules will help small biotechs deliver the medicines we need
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Bio.News  •  April 28, 2020
ICYMI: New SEC rules that went into effect yesterday will help small biotechs research the medicines we need for COVID-19 and many other diseases. There's also more news on one BIO member doing incredible research with animal biotech to help humans fight this pandemic. Here are around 800 words, 4 minutes.
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BIO BOARDLIST
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A vital dose of vaccine education
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Bio.News  •  April 27, 2020
It’s World Immunization Awareness Week, with the theme Vaccines Work for All. The world is watching the biotech industry race to find a COVID-19 vaccine—yet anti-vaccination rhetoric is, unfortunately, alive and well. Today’s new episode of the I AM BIO Podcast explores the importance of vaccines, and how a COVID-19 vaccine will bring the world out of this crisis. Here are around 730 words, 3 minutes, 30 seconds.
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COVID-19’s true origins
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Bio.News  •  April 24, 2020
For your weekend listening, we have a new episode of the I AM BIO Podcast with a world-renowned zoonotic disease expert who explores the origins of the coronavirus—and some of it may surprise you. Here are 605 words, or 3 minutes.
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Attorney for Agriculture & Environment
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Position Title:  Attorney for Agriculture & Environment Department:  Legal  Reports to:   1) President, Advocacy, Law and Public Policy Division, and                       2) General Counsel & SVP Legal Primary Purpose of the Position:  Provide regulatory counseling and litigation management regarding legal, policy, and regulatory matters for the Agriculture and Environment groups at BIO. This advocacy counseling primarily involves any litigation and regulatory activities related to USDA, EPA and FDA, as well as any related legislative and advocacy activities.  Also serve as in-house counsel providing legal services for the organization, including supervising compliance and contractual matters, as well as training for BIO attorneys and staff. Responsibilities: Provide legal assistance, training and supervision, as needed, on contracts and compliance, as well as state, federal, and international legislative, regulatory, and trade-related matters for BIO on non-health matters, including evaluating and developing comments on regulatory proposals, proposed legislation, and other documents. Serve as legal counsel to the Agriculture and Environment groups at BIO, including regulatory counsel and support, litigation management and support, antitrust counsel, corporate legal support, and advice and support on governance and compliance issues. Serve as counsel to section Boards for Agriculture and Environment, and all related staff-level committees, work streams and working groups. Provide legal assistance on voluntary industry self-regulatory initiatives (e.g., product stewardship and transparency) and communication campaigns related to Agriculture and Environment.  Manage the efficient use of outside counsel within all of the above subject matters. Assist with other legal activities of the organization, as requested by the General Counsel (GC) and…
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J&J launches live COVID-19 web series
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Bio.News  •  April 23, 2020
Mark your stay-at-home calendar! Next Tuesday, April 28, join Medexprim and Graticule for a free webinar on how global collaboration can help us build much-needed real-world data for treating COVID-19. Click here to register...because if there's one thing we love more than Netflix right now, it's collaboration. Today, we have an update on the global food supply chain and why One Health matters, plus links to Johnson & Johnson’s new web series about a COVID-19 vaccine, in around 715 words, or 3 minutes, 30 seconds.
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Why COVID-19 has made Earth Day and antibiotics more significant
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Bio.News  •  April 22, 2020
Microsoft has teamed up with BIO members Takeda and CSL Behring to recruit patients who have recovered from COVID-19 to donate their plasma—yet another shining example of how the industry is coming together to collaborate in innovative ways to defeat this thing. In other news, today we're celebrating 50 years of Earth Day—and we’re taking a look at the links between humans, animals, and the environment and what it means for the pandemic. We’ve also got an update from Pew on the antibiotic pipeline and why even patients fighting a virus need to worry about superbugs. Here are 780 words, around 4 minutes.
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Why COVID-19 has made Earth Day and antibiotics more significant
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Bio.News  •  April 22, 2020
Microsoft has teamed up with BIO members Takeda and CSL Behring to recruit patients who have recovered from COVID-19 to donate their plasma—yet another shining example of how the industry is coming together to collaborate in innovative ways to defeat this thing. In other news, today we're celebrating 50 years of Earth Day—and we’re taking a look at the links between humans, animals, and the environment and what it means for the pandemic. We’ve also got an update from Pew on the antibiotic pipeline and why even patients fighting a virus need to worry about superbugs. Here are 780 words, around 4 minutes.
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Why Bayh-Dole matters more than ever
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Bio.News  •  April 21, 2020
Another Tuesday. Our industry’s still working hard on coronavirus breakthroughs—but some lawmakers want to put those vaccines and treatments at risk by making changes to the Bayh-Dole Act, which helps partnerships and R&D happen. We discuss why the law matters more than ever, plus a look at how your coffee habit could help clean up the planet and provide the products we need, in about 660 words, or 3 minutes, 20 seconds.
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BIO Comments on Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
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Human Health  •  Letters, Testimony & Comments  •  April 20, 2020
Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance). General Comments: As noted in the introduction of the Draft Guidance, several guidance documents address, to variable extents, nonclinical immune system safety assessments. While the stated purpose of this Guidance is to supplement the recommendations provided in the existing guidances, as pointed out in the more detailed comments below, the language and organization of the proposed Draft Guidance lacks clarity and/or appears to conflict with existing guidance. In its current form we are concerned that the Draft Guidance will mislead some Sponsors, particularly those who do not have immunotoxicity expertise, and lead to either inadequate safety packages or unnecessary animal studies. Full the full comments, please click on the link below.
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