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Good Day BIO: News from Mexico and JPM
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Bio.News  •  January 10, 2023
Today, we have a readout from the North American Leaders’ Summit and what BIO said about Mexico’s plans to ban biotech corn, plus news from JPM and Capitol Hill. (730 words, 3 minutes, 39 seconds)
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Groups Call on North American Leaders to Follow USMCA to Resolve Disputes, Grow Trade
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Press Release  •  January 9, 2023
The governments of Mexico, Canada and the United States should look to the framework in the U.S.-Mexico-Canada Agreement to continue growing the complementary trade and integrated markets throughout North America, agriculture-related associations said in a joint statement as the heads of the three nations gather today in Mexico City.   The groups encouraged the three governments to take advantage of relevant USMCA committees to align on best practices and resolve trade disputes such as Mexico’s proposed ban on some uses of biotech corn and other agricultural technologies.   “Through science- and risk-based policies that are efficient, predictable, and compliant with international obligations, North American markets can embrace technology that advances food security, agricultural sustainability and rural prosperity and foster a variety of cost-effective food choices for our consumers,” the groups wrote.   The three nations enjoy the largest trilateral agricultural trade relationship in the world. Agricultural trade in North American has grown from $7.8 billion to $67 billion, a 769.7% increase since the North American Free Trade Agreement took effect in 1994. USMCA replaced NAFTA in 2020 and provided “the world’s best framework” to turn the supply chain challenges of the last few years into an opportunity to further strengthen North American trade in agricultural products, the groups added.   “USMCA’s enhanced provisions for agricultural biotechnology set it apart from previous trade agreements,” said Beth Ellikidis, vice president of agriculture & environment at the Biotechnology Innovation Organization. “We are hopeful that the discussions taking place this week in Mexico City will affirm the importance of agricultural innovation for tackling climate change and food security and ensure our trading partners have functional regulatory systems that promote transparency and cooperation consistent with the agreement.”   “Any…
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Good Day BIO: What's next for mRNA, Alzheimer's, and food innovation
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Bio.News  •  January 9, 2023
As the House gets to work on the rules package, we take a look at the future of mRNA, how biotech can combat global hunger, and news from Eisai and the CDC. (673 words, 3 minutes, 21 seconds)
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Good Day BIO: Vaccines remain best defense against new COVID-19 subvariant
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Bio.News  •  January 6, 2023
Will we have a Speaker of the House today? In the meantime, let’s learn more about the newest COVID subvariant, what’s next for LanzaJet, and the AMR Action Fund’s new investment. (583 words, 2 minutes, 54 seconds)
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Inflation Reduction Act – Medicare Part D Redesign/ Patient Out-Of-Pocket Cap
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Human Health, Inflation Reduction Act  •  Toolkit  •  January 6, 2023
The IRA restructures the Medicare Part D benefit to provide financial protections for beneficiaries and changes the contribution structure for plans, the government, and manufacturers.
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IRA - Medicare Part D and ‘Smoothing’ of OOP Costs/MPPP
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Human Health, Inflation Reduction Act  •  Toolkit  •  January 6, 2023
Currently, millions of Medicare beneficiaries reach the catastrophic phase in January or February, which exacerbates the financial hardship of the high prices of OOP costs. The Inflation Reduction Act (IRA) will allow Medicare beneficiaries to spread their out-of-pocket cost over the course of the plan year.
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Good Day BIO: Will this be the year 340B is fixed?
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Bio.News  •  January 5, 2023
Everyone’s been talking about 340B—could this be the year the program is finally fixed? Plus, new evidence shows how climate change is making us sicker. (650 words, 3 minutes, 15 seconds)
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Good Day BIO: Calling all biotech innovators
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Bio.News  •  January 4, 2023
While waiting to see who will win Speaker of the House, you can apply for the Start-Up Stadium at this year’s BIO International Convention, and check out a new down coat made with sugarcane and biotechnology. (540 words, 2 minutes, 42 seconds)
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BIO Submits Comments on FDA Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
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Letters, Testimony & Comments  •  January 3, 2023
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which enroll pediatric participants. As planning, conducting, and recruiting for clinical trials that involve pediatric patients can be challenging, BIO is appreciative to FDA for developing clear recommendations that sponsors can refer to when developing and operationalizing their clinical protocols. To make the guidance more broadly applicable, BIO suggested FDA consider expanding on the topic of body proportionality, especially for rare conditions associated with disproportionate stature or measurements. Furthermore, though the examples of measurement tools FDA provides in the guidance are useful, some may not be available at all sites. To overcome this issue, BIO requested that the Agency maintain flexibility around the specific tools sponsors use. Lastly, BIO suggested that including recommendations on which timeframes offer the most meaningful data for specific growth and development measurements (e.g., clarification on whether 12 months is sufficient to provide clinically meaningful information for growth and development) would be beneficial to sponsors.  
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Good Day BIO: USTR ag negotiator confirmed and other news you missed
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Bio.News  •  January 3, 2023
Happy New Year! As the 118th Congress begins, catch up on the news you missed during the break, from the approval of key ag trade officials to the advancement of new biotech breakthroughs. (611 words, 3 minutes, 3 seconds)
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