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Good Day BIO: What happened in the Senate last night
Good Day BIO Newsletter  •  August 11, 2021
It was a long night on Capitol Hill. Here’s a quick recap of what happened in the Senate and where to find more information on the infrastructure and budget bills, plus a few good reads you might have missed. (551 words, 2 minutes, 45 seconds)
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Open Letter to the President of the United States: The Need for U.S. Leadership in Global Vaccinations
Letters, Testimony & Comments  •  August 10, 2021
We want to commend you and your Administration for the global distribution of millions of doses of the COVID-19 vaccines. Our friends in recipient countries are truly grateful. Nonetheless, in order to gain control of the pandemic, a much more considerable effort will be required to inoculate the global population. Millions of people in Latin America, Africa and Southeast Asia continue to have little or no access to vaccines and remain desperate as the delta variant becomes increasingly rampant worldwide. Helping to vaccinate populations in other countries is an investment in our own safety as well as global stability. The longer the virus spreads, the more opportunity it has to mutate into new and more vaccine-resistant variants and lead to the further breakdown of societies.
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Good Day BIO: We need U.S. leadership in global vaccinations
Good Day BIO Newsletter  •  August 10, 2021
Today, BIO’s joining government and business leaders in calling for U.S. leadership on global vaccination. We also take a closer look at the new UN report on climate change—and how biotech offers solutions to lessen the impact. (681 words, 3 minutes, 24 seconds)
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BIO Comments on Core PROs in Cancer Clinical Trials
Human Health  •  Letters, Testimony & Comments  •  August 9, 2021
On Thursday, June 10th, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance, Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials, providing recommendations to sponsors on the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. According to the FDA, the Guidance is intended to facilitate generation of high-quality data on a core set of patient-reported symptom and functional impacts that are important contributors to a patient's health-related quality of life. On Monday, August 9th, 2021, BIO submitted comments to the FDA on the draft guidance. While BIO does not typically comment on disease-specific guidances, BIO acknowledges that many of the concepts presented in the draft guidance can and should be utilized more broadly. In the comments submitted, BIO suggests that the Agency provide clarity on FDA-Sponsor meetings regarding the use of PROs; for example, the timing, meeting type, recommended attendees, and necessary information for sponsors to prepare in anticipation of the discussion. Additionally, BIO notes that some of the Agency’s suggested PROs, such as disease-related symptoms and symptomatic adverse events, may appear repetitive and burdensome to patients. From a clinical perspective, BIO recommends a flexible approach in selecting functional scale(s) so that they can be chosen based on the context of a given disease, rather than adding a role function to the core concept. Further, we suggest adding treatment symptoms to the list of core PROs to avoid measurement redundancy across disease symptoms and treatment symptoms. Additionally, we believe it would be helpful if the FDA addressed the topic of PRO data collection and adverse event (AE) reporting in clinical trials and clarified how PRO data enhance safety data. Lastly, BIO states that it would be helpful if the FDA included more pediatric-specific…
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Good Day BIO: SEC approves board diversity proposal
Good Day BIO Newsletter  •  August 9, 2021
It’s a new week—and the SEC approved an important Nasdaq proposal that will improve diversity and inclusion in public companies. We tell you how you can get more details, plus look at why opposition to GMOs has been so misplaced. (655 words, 3 minutes, 16 seconds)
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BIO Submits Comments to the USPTO on Discretion to Institute Trials Before the Patent Trial and Appeal Board
Intellectual Property, Patents  •  Letters, Testimony & Comments  •  August 6, 2021
BIO submitted comments to the United States Patent and Trademark Office in response to the USPTO's consideration of “the codification of its current policies and practices, or the modification thereof,” relating to the exercise of its discretion under 35 U.S.C. §§ 314(a), 324(a), 315(d), and 325(d)."
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Good Day BIO: Asian governments race to avoid last place in COVID-19 response
Good Day BIO Newsletter  •  August 6, 2021
Closing the week with an update on COVID-19 and COVAX in Asia as the Tokyo Olympics wind down—and a must-read warning about why America must embrace the biotech sector. (751 words, 3 minutes, 45 seconds)
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Good Day BIO: States push anti-vax bills and executive orders
Good Day BIO Newsletter  •  August 5, 2021
Today, we look at the alarming number of anti-vaccine laws popping up in states across the country, as well as the latest on what USTR is doing about biotech in Mexico. (784 words, 3 minutes, 55 seconds)
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LES Pharma Webinar Series: IP Litigation in the Pharmaceutical Industry
BIO Professional Development Courses  •  August 4, 2021
IP Litigation in the Pharmaceutical Industry: The Case of Brand vs Generic Products The drug patent system was created to reward pharma companies for innovation and ensure returns on investment. IP protection and commercial exclusivity regulated by the Drug Price Competition and Patent Restoration Act (Hatch-Waxman Act) provides protection to drug innovators and also provides the pathway for generic manufacturers to challenge NDA holders patent(s) and apply for a PIV-Abbreviated New Drug Application (ANDA) for approval of a generic product prior to the expiration of the innovator product patents. Resolution of patent infringement becomes the subject of a litigation. Intellectual Property litigation in the pharmaceutical industry will be the subject of discussion of our next webinar series. Our panel of experienced experts have represented either the brand or generic side of this dynamic and will present a three-part overview of these and related issues. Webinar Series Topics Part 1: Pre-Litigation Strategies: PIV and Biosimilars Part 2: Patent Infringement Lawsuit Part 3: IP Litigation Settlement/Antitrust Litigation Webinar Speakers: Daisy Rivera-Muzzio, R.Ph, MS, MBA, President of Acumen BioPharma Daisy Rivera-Muzzio is the president of Acumen BioPharma, a firm that offers scientific and commercial operational consulting services to pharmaceutical companies and law firms related to intellectual property and antitrust litigation in pharma. Mrs. Muzzio also serves as the Chief Operating Officer for Integra continuous Manufacturing Systems, a consulting firm dedicated to advanced pharmaceutical manufacturing technologies integrating services of equipment manufacturers, PAT controls, and formulation expertise in the development and implementation of continuous manufacturing technologies in the life science industries. Josh Reisberg, Esq., Partner at Axinn Josh Reisberg is a Partner at Axinn and focuses his practice on intellectual property and high…
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Good Day BIO: A golden opportunity for global nutrition
Good Day BIO Newsletter  •  August 4, 2021
The Philippines is the first country to approve Golden Rice for commercial production—we have the details. Plus, the American Heart Association (AHA) explains why diversity matters in genomic research and what we can do to improve it. (731 words, 3 minutes, 39 seconds)
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