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  • Regulatory NewsRegulatory News

    COVID-19 vaccine: Experts warn of waning public confidence

    Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine .   Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposi...
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    Hahn says COVID-19 vaccines will be reviewed in ‘real time’

    At an event marking the launch of Moderna’s Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami on Monday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn repeated assurances that his agency would not cut corners in approving a COVID-19 vaccine.   Pfizer also announced on Monday that it would begin a Phase 2/3 study of its COVID-19 vaccine developed in partnership with BioNTech. Both companies say they plan to enroll 30,000 participan...
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    Lawmakers ask FDA to outline COVID-19 vaccine approval process

    Key Democratic members in the US House of Representatives have called on Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.   In a letter dated 18 June, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairma...
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    Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...
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    Sanofi Raises Public Health Questions on Use of Nonsense Suffixes With New Vaccines

    A lot of ink has been spilled on the controversial random suffixes that the US Food and Drug Administration (FDA) is now tagging on the end of the nonproprietary names of biologics and biosimilars. Back in January 2017, FDA finalized a guidance document spelling out how this four-letter, FDA-designated meaningless suffix would be attached at the end of biologics’ and biosimilars’ nonproprietary names. Later in 2017 and 2018, companies began to realize FDA was only u...
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    Asia Regulatory Roundup: China Posts Guiding Principles on Device Trials (9 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Seeks Feedback on Drug Data Management Practices China is seeking feedback on its draft drug data management practices. The China Food and Drug Administration (CFDA) text details how individuals and organizations involved in the development, production, distribution and monitoring of drugs should ensure the accuracy and traceability of the data they generate. C...
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    European Regulatory Roundup: MHRA Chief Floats Faster Reviews, Closer Ties to NICE (19 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Chief Floats Faster Reviews, Closer Ties to NICE as Post-Brexit Options for UK The head of the United Kingdom’s regulatory agency has sketched out some of the ways it may change after Brexit. Dr Ian Hudson stressed the UK wants a collaborative, ongoing relationship with the European Medicines Agency (EMA) but is preparing for the opportunities — and risks — that w...
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    Pfizer Wins Indian Patent on Prevnar 13 Vaccine

    India's patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims. The decision follows a campaign from MSF that began in March 2016 to allow for more affordable versions of the vaccine to come to market in India. In October 2016, MSF rejected a Pfizer offer to donate a significant number of PCV doses. "By giving the pneumonia vaccine away for fre...
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    Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine

    Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds. "MSF objects to the granting of an exclusive patent license on a U.S. government-funded invention to a single pharmaceutical company as well as to the lack of conditions to ensure the vaccine will be appropriately developed and made available and ...
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    European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU GMP Inspectors Issued Non-Compliance Statements to 11% of Indian Sites Visited in 2016 Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three prev...
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    FDA Offers 2016 Report on Medical Countermeasure Activities

    As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities. With a budget of a little more than $110 million, FDA’s MCM efforts play a  critical role  in protecting the US from dangerous threats and emerging infectious disease threats, such as pand...
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    Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine

    Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi fired back on Tuesday explaining the risks of developing such a vaccine. According to a Federal Register notice from 9 December, the Department of the Army of the US Department of Defense intends to grant an exclusive, royalty-bearing, revocable license on a patent entitled, ‘‘Zika Virus Vaccine an...