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BIO responds to “unconscionable” attacks on U.S. Capitol
Good Day BIO Newsletter  •  January 7, 2021
Yesterday was an extraordinary day in American history. BIO staff and colleagues who live and work near the U.S. Capitol are safe. Our thoughts are with the families of the four individuals who lost their lives, and with lawmakers and staff, Capitol Police who ushered them to safety, and the journalists who risked their lives to report from the scene. Below, we have BIO President and CEO Dr. Michelle McMurry-Heath’s statement on the events, and a lot of news. (625 words, 3 minutes)
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BIO's Dr. Michelle McMurry-Heath Responds to "Unconscionable" Attacks on U.S. Capitol
Press Release  •  January 7, 2021
Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization, made the following comments in response to today's violence at the United States Capitol: "Today we watched in horror as angry and unruly mobs attacked the United States Capitol in an effort to overturn the results of a democratically held election. "At BIO, we vigorously supported and encouraged scientists of all sorts to become actively involved in the political process, support their candidates from whichever party, and make their voices heard by voting. In an unprecedented election, millions of voters went to the polls and did just that. "It is simply unconscionable for an angry mob, upset by an election outcome to try to disenfranchise the votes of millions of Americans simply because their chosen candidate lost. "As we are staring down a global pandemic, it is now more critical than ever for Congress to return to their important work and join together in a unified front to fight the disease and not each other. The time has come for leaders of both political parties to collectively say enough is enough and return our country to civility and the rule of law."  
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Preliminary injunction blocks Trump’s drug reimbursement plan
Good Day BIO Newsletter  •  January 6, 2021
From Georgia to the U.S. Capitol, it’s a big news day. Meanwhile, over the holidays, a court issued a preliminary injunction blocking Trump’s Most Favored Nation drug reimbursement plan. We also tell you what to expect from Biden’s pick to lead USDA. (890 words, 4 minutes, 30 seconds)
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Thank You for Downloading the Membership Brochure
Thank you for downloading the BIO Membership Brochure! You can access the brochure below, and we will also send you a copy via email to keep for your records and pass along to your colleagues. If you have any questions about BIO Membership, please contact us at biomember@bio.org.    Download Now   More about BIO Membership Member Directory Policy Committees Conference and Event Discounts BIO Business Solutions
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We have the vaccines—now we need a vaccination plan
Good Day BIO Newsletter  •  January 5, 2021
All eyes are on Georgia, where today’s two U.S. Senate runoff elections will determine the balance of power in Washington. In the meantime, we’re looking at why we need a national vaccination plan and what investors are thinking about synthetic biology and gene editing. (777 words, 4 minutes)
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Can we pass this COVID test?
Good Day BIO Newsletter  •  January 4, 2021
Happy New Year. We’re kicking off a busy week in Washington with a look at the role of CRISPR in fighting the pandemic—and how this might lead to other innovations in the future. (1,000 words, 5 minutes)
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What we've been reading over the holidays
Good Day BIO Newsletter  •  December 30, 2020
We hope you and your loved ones are staying healthy and safe this holiday season. Good Day BIO is still on a break, but we wanted to pop in to send you a few things we've been reading and remind you to mark your calendars for BIO's first events of 2021. (830 words, 4 minutes, 28 seconds)
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Injunction Placed on Punitive and Political Maneuver by Administration
Patient Advocacy, Cost & Value of Biopharmaceuticals  •  Press Release  •  December 29, 2020
A judge in the United States District Court for the Northern District of California yesterday issued a preliminary injunction blocking the Administration’s “Most Favored Nation” reimbursement policy for certain drugs administered by Medicare Part B providers. The issuance comes weeks after the Biotechnology Innovation Organization (BIO), the California Life Sciences Association (CLSA), and BIOCOM California filed a challenge against the rule.  Dr. Michelle McMurry-Heath, BIO President and CEO, made the following comments in response to the preliminary injunction: “We are pleased with the court’s decision to grant a preliminary injunction on the president’s reckless scheme of foreign price controls on the very scientists working to end our current pandemic. “Arbitrary government price setting creates unnecessary barriers for scientists and researchers ushering in the next generation of lifesaving cures, destroys the next generation of medical innovation, and eliminates hope for Americans desperately waiting for cures and treatments.” Joe Panetta, President and CEO of BIOCOM California said the following: “Biocom California applauds this preliminary injunction and stands firm with our partners in opposing a deeply-flawed plan to impose arbitrary foreign price controls on drugs and biologics that are administered in physicians’ offices. Models such as MFN reduce long-term investments in research and hamper the development of new treatments and cures – the wrong path to take when our patients, our economy and our whole nation are looking to the biotechnology industry for hope during our most deadly national pandemic in recent history.   Biocom California looks forward to participating in future dialogues on drug pricing policies that include comprehensive stakeholder input and expand patient access.”   Mike Guerra, President and CEO of CLSA, also commented: “CLSA applauds Judge Chhabria’s order since this IFR seeks to implement a sweeping new…
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BIO Comments on FDA’s Public Workshop on Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation
Human Health  •  Letters, Testimony & Comments  •  December 23, 2020
On Wednesday, December 23rd, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s October 2020 public workshop titled, “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” In its comments, BIO stated that the FDA’s new integrated review documentation is much improved from the older template as it is easier to navigate and provides greater clarity and transparency on key information considered in the review process. However, BIO requests that the Agency ensures any relevant information is not removed or omitted as the new documentation is implemented, and that this information remain publicly available. BIO also proposed additional strategies for the Agency to utilize in increasing transparency in the regulatory approval process. Lastly, given current technology, BIO encouraged the FDA to consider providing the information included in the integrated review in an electronic format that can easily be searched across products.  
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What you need to know about vaccine allocation
Good Day BIO Newsletter  •  December 23, 2020
Don’t put on your “out of office” message quite yet, because we have a few things you need to know about COVID-19 vaccine allocation. Plus, we close the year with a look at some of our newest members and why they decided to join. (863 words, 4 minutes, 18 seconds)    Good Day BIO is taking a holiday break—and we hope you do, too. We will resume normal publication on Monday, January 4, 2021, though we will pop in your inbox if there’s major news. Happy Holidays!
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