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FDA approves first RSV vaccine
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Bio.News  •  May 4, 2023
Exciting news from BIO members today, as the FDA has approved the first RSV vaccine in the U.S. for older adults, and Eli Lilly has promising news about its Alzheimer’s drug. Meanwhile, a new analysis asks: who will pay for transformative therapies? (640 words, 3 minutes, 12 seconds)
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Inquiry Form for ODP Business Solutions
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BIO Business Solutions
BIO Business Solutions® is the largest cost savings purchasing program for the biotech industry operated by the Biotechnology Innovation Organization (BIO). With more than half a billion in annual sales, BIO Business Solutions® aggregates the purchasing power of over 4,700 life science companies from North America. Companies of all sizes save substantial money each year through this cost-savings program. To request information for the BIO-ODP Program, please fill the fields below and click the Submit button at the bottom of the form.   MktoForms2.loadForm("//app-ab15.marketo.com", "490-EHZ-999", 3818);  
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SBA Policy Directive: SBIR Foreign Investment Template
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May 3, 2023
The Small Business Administration is amending the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs Policy Directive to incorporate a template for agencies participating in the SBIR or STTR programs (Participating Agencies) to request the disclosure of statutorily required information from SBIR or STTR applicants. These revisions to the SBIR/STTR Policy Directive take effect on May 3, 2023, without further action, unless significant adverse comment is received by May 3, 2023. For more information, please contact John Guy (Jguy@bio.org).
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PBM vote delayed to May 11
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Bio.News  •  May 3, 2023
We recap what happened at yesterday’s markup of PBM legislation, and look at how gene editing could eliminate allergens from eggs. (495 words, 2 minutes, 28 seconds)
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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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Bio.News  •  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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Bio.News  •  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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Bio.News  •  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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