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BIO Comments to FDA (No. FDA–2022-D-2983) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
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Letters, Testimony & Comments  •  May 2, 2023
BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.
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What's in USTR's IP report
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Good Day BIO Newsletter  •  May 2, 2023
USTR released its annual report on global IP protections—we take a closer look at what’s in it, and BIO’s take. Plus, we tell you why you should know about the lablab bean. (547 words, 2 minutes, 44 seconds)
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BIO Comments to FDA–2023-N-0487: Discussion Paper: Artificial Intelligence in Drug Manufacturing
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Letters, Testimony & Comments  •  May 1, 2023
In these comments to FDA, BIO supports FDA’s efforts to improve future guidance related to Artificial Intelligence in Drug Manufacturing and outlines recommendations for FDA’s review and further consideration.
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House hearing spotlights AMR threat
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Good Day BIO Newsletter  •  May 1, 2023
Kicking off a new week and month with a recap of Friday’s AMR hearing, and a look at new biotech shirts on sale now at lululemon. (565 words, 2 minutes, 49 seconds)
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PASTEUR Act reintroduced
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Good Day BIO Newsletter  •  April 28, 2023
Busy Friday: the PASTEUR Act was reintroduced yesterday, and a hearing today will look at the emerging threat of AMR. Plus, six things we’re watching on PBMs and a recap of yesterday’s hearing on patents and IP. (845 words, 4 minutes, 13 seconds)
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Organizations Focused on Fight Against Superbugs Celebrate Reintroduction of the PASTEUR Act
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Press Release  •  April 27, 2023
Groups urging need for revitalizing antimicrobial development call for passage of the bill this year  Today, five prominent national organizations — the Biotechnology Innovation Organization, the Cystic Fibrosis Foundation, the Infectious Diseases Society of America, the Partnership to Fight Infectious Disease, and The Pew Charitable Trusts — issued the following statement in response to the reintroduction of the Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act: The reintroduction of the bipartisan PASTEUR Act by the U.S. House of Representatives and the Senate is a critical step forward to address the antimicrobial resistance crisis that threatens the public health and U.S. national security and preparedness. We applaud the efforts of Senators Michael Bennet (D-CO) and Todd Young (R-IN) and Representatives Drew Ferguson (R-GA) and Scott Peters (D-CA) to keep this vital issue a key priority for congressional action this year.  Initially introduced in the 116th Congress, PASTEUR has gained broad, bipartisan support because of its balanced approach to catalyze the development of urgently needed antibiotics and antifungals while also supporting appropriate use of existing medications, which is key to preserving their efficacy and slowing the spread of dangerous, drug-resistant superbugs. Before the end of the last Congress, the bill had the support of more than 70 House and Senate co-sponsors. Earlier this year, President Joseph R. Biden Jr.’s administration urged Congress to pass this type of policy, while more than 230 organizations representing health care providers, public health professionals, scientists, patients, and the pharmaceutical and diagnostics industries joined in a letter to congressional leaders calling for the passage of PASTEUR as soon as possible.  Antimicrobial resistance is not a partisan issue. It is an increasingly challenging public health emergency that reverberates…
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Call for Sessions for BIO's Impact Ag & Environment Conference
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Press Release  •  April 27, 2023
BIO’s Impact Ag & Environment Conference, Sept. 19-20, 2023, in Raleigh, N.C., is an opportunity for companies and non-governmental organizations working across agriculture, bioprocessing, and climate adaptation/mitigation to connect and collaborate. With sessions on climate change and food security, market access and acceptance and promoting innovation, the conference presents opportunities to hear from leaders in government, business and academia on some of today’s leading issues.Are you interested in presenting a session at this year’s Impact Conference? Know someone who might be? Please click or share the link to BIO’s call for sessions and let us know what our conference attendees need to hear about at this year’s Impact!  What:           The BIO Impact Ag & Environment Conference is the premier gathering of global biotech leaders for discussion, partnering and networking to advance the role of science in enhancing agriculture and improving the environment. BIO has issued a call for sessions to give all interested companies and organizations an opportunity to propose presentations.When:          Call for sessions: Open now through May 1, 2023                       Conference dates: Tue., Sept. 19, – Wed., Sept. 20, 2023      Where:         Raleigh Convention Center                      500 S. Salisbury St.                      Raleigh, NC 27601Why:            The Impact Ag & Environment Conference (formerly World Congress) is the place to hear from thought leaders, forge partnerships and celebrate the many ways in which biotech innovations are…
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House advances bills to boost small biotechs
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Good Day BIO Newsletter  •  April 27, 2023
A busy day on Capitol Hill advanced several BIO-backed bills that would help small biotechs, plus hearings that covered topics including PBMs, price controls, and 340B. (594 words, 2 minutes, 58 seconds)
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Weathering The Storm: How To Navigate A Slowing Investor Market
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Webinars  •  April 27, 2023
During this webinar, panelists discuss strategies for biotechnology companies to manage economic downturns and weakened investor interest in the biotech industry. Our expert panel of industry leaders share their insights and experiences on how to maintain momentum and emerge stronger during periods of economic uncertainty. This webinar is designed to provide practical advice and actionable strategies that can be implemented immediately. The panel covers the following topics: • Effective communication and investor relations strategies during economic downturns • Actions biotechs can take to cut costs without sacrificing innovation and growth • How to pitch to investors during weakened investor interest periods
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BIO Office Hours: Cash Management with Brex
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April 26, 2023
Experts from Brex will be available for twenty-minute virtual appointments to answer questions and offer guidance on how to manage your business accounts and preserve capital during uncertain times. Use the attached link to complete the questionnaire and schedule your twenty-minute session. Please note that this is offered on a first come first served basis. BIO will send you a calendar invite with your scheduled appointment time and Zoom participation link within 24-hours as confirmation.   Schedule Office Hour
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