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IRA Medicare Inflation Rebates: At A Glance
Human Health, Inflation Reduction Act  •  Toolkit  •  January 2, 2023
The Inflation Reduction Act (IRA) of 2022 requires biopharmaceutical companies to pay rebates to the government if the price for drugs in Medicare Part B or Part D increase faster than the rate of inflation.
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Good Day BIO: Our most-clicked stories – plus, the latest on TRIPS
Bio.News  •  December 22, 2022
It’s our last issue of Good Day BIO for the year, so we’re giving you some holiday reading: our most popular stories on Bio.News and a few exclusives you need to read before the new year, plus the latest on the TRIPS waiver and government funding. (685 words, 3 minutes, 25 seconds)Good Day BIO will be on break for the holidays, returning Tuesday, January 3. In the meantime, keep an eye on Bio.News to stay up to date. We hope you have a wonderful holiday and look forward to seeing you in 2023!
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Good Day BIO: Tell the government how it can support biotech
Bio.News  •  December 20, 2022
The government wants you to weigh in on how to streamline biotech regulation and the value of the bioeconomy—we tell you how. Plus, BIO’s been working with international partners on global regulatory harmonization of pharmaceutical regulations, which could help us prepare for the next pandemic. (613 words, 3 minutes, 3 seconds)
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What's in the government funding package
Bio.News  •  December 20, 2022
BIO experts have been analyzing the 4,155-page omnibus spending bill since it was delivered around 2 a.m. yesterday. There are key provisions related to biopharma, agriculture, and environment. (805 words, 4 minutes, 1 second)
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Good Day BIO: Mexico proposes amendments to corn ban
Bio.News  •  December 19, 2022
We’re officially in the home stretch of the year. Today, we have news on Mexico’s proposed corn ban, a recap of BIO’s event during the U.S.-Africa Summit and what it means for cancer in Africa, and a lot more health news. (791 words, 3 minutes, 57 seconds)
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Good Day BIO: Midterms recap and Mexico's corn ban
Bio.News  •  December 16, 2022
For your weekend reading, we have our 2022 midterms recap: what happened, why it matters, and what the results mean for biotech innovation and patients. Plus, ahead of Agriculture Secretary Vilsack’s meeting with Mexico today, bipartisan Senators are calling for the U.S. to take action on the proposed corn ban. (740 words, 3 minutes, 42 seconds)
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Good Day BIO: FDA cut back on Accelerated Approvals in 2022
Bio.News  •  December 15, 2022
With appropriations negotiations underway on Capitol Hill, we look at what some members of Congress want the package to say about genome editing for food. Plus,the FDA cut back on use of Accelerated Approval in 2022—a very unwelcome holiday surprise for patients.  (634 words, 3 minutes, 10 seconds)
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Good Day BIO: COVID vaccines at two years
Bio.News  •  December 14, 2022
Hard to believe the first COVID vaccines were administered in the U.S. two years ago today—here’s more on the impact on lives and money saved, and future R&D. Plus, President Biden’s hosting the U.S.-Africa Leaders Summit and today will highlight the role for biotech. (501 words, 2 minutes, 30 seconds)
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BIO Comments on FDA Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs
Letters, Testimony & Comments  •  December 13, 2022
On Tuesday, December 13th, BIO submitted comments in response to a recent FDA discussion paper for stakeholders on distributed manufacturing (DM) and point-of-care (POC) manufacturing. In the comments submitted, BIO commended the FDA on its collaborative approach to addressing unique challenges related to advanced manufacturing and noted that discussion paper provides a timely mechanism to further the harmonization of terminology and concepts around DM and POC. Along with specific feedback on the questions raised by the Agency in the paper, BIO offered several high-level recommendations. For example, it would be beneficial if FDA more clearly conveyed the benefits offered by DM and POC manufacturing while acknowledging the relative risks associated with their introduction. Furthermore, it would be useful if the document recognized and addressed the limitations that manufacturers face in attempting to deploy these technologies in different regions and settings.
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Good Day BIO: Inequities persist in R&D
Bio.News  •  December 13, 2022
Recent data provides more evidence of the need for equity and inclusion in clinical trials and drug development—here’s what we’re doing about it. And while we know the lame duck is busy, the Senate should add two key agriculture nominations to the agenda. (551 words, 2 minutes, 45 seconds)
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