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BioWorld - Wednesday, July 6, 2022
Home » Topics » Regulatory

Regulatory
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South Korea approves first homegrown COVID vaccine

July 5, 2022
By Tamra Sami
No Comments
South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine.
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Japan to create centralized pandemic response agency akin to the US CDC

July 5, 2022
By Tamra Sami
No Comments
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare.
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China issues draft guidelines to speed up cancer drug development via single-arm trials

July 5, 2022
By Doris Yu
No Comments
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
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Green approved stamp

Akeso wins NMPA approval for dual immune checkpoint inhibitor

July 5, 2022
By Doris Yu
No Comments
Akeso Inc. has been given the green light by China’s NMPA for its PD-1/CTLA-4 antibody Kaitanni (cadonilimab), which was approved for the treatment of patients with relapsed or metastatic cervical cancer whose disease has progressed on or after platinum-based chemotherapy.
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Regulatory actions for July 5, 2022

July 5, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ra Medical, Siemens Healthineers.
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Regulatory actions for July 5, 2022

July 5, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genmab, Hyloris, Novartis, Nrx, Provention.
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EU flag, map, charts

EU overwrites expired guidelines for vertical agreements

July 1, 2022
By Mark McCarty
No Comments
Companies in the device and diagnostics spaces are familiar with how government agencies react to acquisitions that bolster the acquiring company’s product pipeline, but vertical mergers provoke a different set of regulatory concerns. The European Commission (EC) recently updated its guidelines for vertical agreements, a development that could hamper some EU corporate activity going forward.
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China issues draft guidelines to speed up cancer drug development via single-arm trials

July 1, 2022
By Doris Yu
No Comments
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
Read More

Japan to create centralized pandemic response agency akin to the US CDC

July 1, 2022
By Tamra Sami
No Comments
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare.
Read More
FDA vaccine illustration

US guidance on next-gen boosters a new era in COVID-19

July 1, 2022
By Mari Serebrov
No Comments
The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
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