July 29, 2021
DIA Global SmartBrief
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BioNTech to develop malaria vaccine using mRNA tech
BioNTech is exploring development of a malaria vaccine using mRNA technology and will evaluate several vaccine candidates targeting the circumsporozoite protein, with the company planning to launch a clinical trial for the most promising candidate by the end of next year. BioNTech is also considering vaccine production in Africa in an effort to broaden its manufacturing capacity and boost global access.
Full Story: Reuters (7/26) 
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A longer dosing gap for the Pfizer/BioNTech's COVID-19 vaccine was associated with doubled production of neutralizing antibodies against all variants, compared with a short dosing interval ranging between two and five weeks. The study, based on data from 503 health care workers, also found that a six- to 14-week interval between the first and second dose was linked to a higher proportion of helper T-cells, which support immune memory, although T-cell levels were lower overall.
Full Story: PharmaTimes online (UK) (7/26) 
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Effects of COVID-19 on the regulatory landscape
Regulatory agencies focused not only on COVID-19-specific development, but also on minimizing the impact of the pandemic on clinical trials. In this report, we review regulatory responses and how COVID-19 will affect regulatory operations in the longer term. Download now.
Asia Pacific
Samsung Electronics and the Korea Advanced Institute of Science and Technology have developed a gas sensor platform that can diagnose diseases from a person's breath. "The gas sensor platform selectively detects biomarker gas related to diseases from the breath, providing real-time monitoring of certain diseases. By monitoring the changes in the concentration of certain gases in the breath, doctors can make the diagnosis of diseases," the institute stated.
Full Story: Korea Biomedical Review (7/28) 
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North America
A revised manual of policies and procedures was released by the FDA's Office of Generic Drugs outlining internal procedures for handling labeling changes on generic drugs. The document "clarifies that the agreement to submit revised labeling after approval under the provisions of 505(j)(10) is a statutory requirement, now defined as a Post-Approval Labeling Requirement (PALR). As a result, the templates now reference PALR and the MAPP now includes language for a release from the PALR."
Full Story: Regulatory Focus (7/27) 
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An AgencyIQ analysis found generic drug applications dropped to a monthly average of 66 submissions in the first half of this year from a high of 94 submissions per month in 2017. The number of generic drugs that received the FDA's full or tentative approval also declined to 343 and 72, respectively, in the first half of this year, compared with 361 full approvals and 92 tentative approvals in the same period last year.
Full Story: Becker's Hospital Review (7/27) 
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The FDA has requested that Moderna and Pfizer/BioNTech expand the scope and size of clinical trials designed to assess their COVID-19 vaccines in children ages 5 to 11 in an effort to ensure the studies capture rare side effects such as myocarditis.
Full Story: The New York Times (7/26),  CNBC (7/26) 
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Regeneron Pharmaceuticals will collaborate with AstraZeneca to develop a drug that targets the obesity-associated GPR75 gene because the condition is linked to various severe illnesses. The partners will equally share development costs for the trials as well as potential future profit.
Full Story: BioSpace (San Francisco) (7/27) 
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An adjuvanted recombinant vaccine for hepatitis C is being developed at the University of Alberta's Li Ka Shing Applied Virology Institute in Canada and could be ready in the next five years if it is found to be safe and effective, said Sir Michael Houghton, who shared a Nobel Prize in Medicine last year for discovering the virus. "While the advent of directly acting antivirals to cure hepatitis C has given us a huge weapon to turn the tide on this pandemic, there is no doubt that a vaccine is required to help the world reach its ambitious target of reducing new hepatitis C infections by 90% and mortality rates by 65% by 2030," Houghton said.
Full Story: Healio (free registration) (7/26) 
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DIA News
There's no need to travel to expand your knowledge and skills. DIA's live virtual training and self-paced online courses can help you achieve both your personal and professional goals from wherever you are.

Join us for "Regulatory Affairs: The IND, NDA, and Post-Marketing" taking place August 16-20.

Learn with your peers in a real-time virtual setting AND earn Continuing Education credits! Our regulatory instructors have years of experience and will guide you through FDA regulations and expectations for the content, submission, and review of INDs/NDAs. Meet our instructors.

What will you learn?

• The importance of incorporating regulatory strategy into the drug development plan

• The requirements for submitting INDs/NDAs and amendments and supplements

• Regulatory programs and mechanisms that can facilitate and expedite new drug development

• How to report adverse events in accordance with current FDA regulations

• How to apply sound meeting practices and productive dialogue when interacting with the FDA
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DIA's revamped "Master Protocols and Complex Innovative Design" meeting, taking place November 4-5, will bring together a truly multidisciplinary group of experts in clinical trial planning, execution, and analysis to discuss the myriad challenges and opportunities in the adoption of master protocols and complex innovative design. Join industry, patient, regulatory agency, government, and NGO representatives to examine the growing body of knowledge, experience, and resources available to better meet patient needs. Don't wait -- early-bird rates expire August 12!
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