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BioWorld - Thursday, February 5, 2026
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Regulatory
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Globe showing Australia

Australia’s Mesoblast submits final module of rolling BLA submission for pediatric GVHD stem cell therapy

Feb. 4, 2020
By Tamra Sami
PERTH, Australia – Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).
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Time perception clocks

With rapid transmission of 2019-nCoV, how fast is fast enough for communication?

Feb. 4, 2020
By Anette Breindl and Elise Mak
BEIJING – The current speed of new developments in the 2019-nCov outbreak is illustrated by a Jan. 28, 2020, press conference in Munich, where Andreas Zapf, head of the infection task force in the Bavarian ministry for health and food safety, briefed reporters on the first confirmed German case.
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Japan flag doctor

Japan’s drug repricing plan to hit some top sellers

Feb. 4, 2020
By Jihyun Kim
HONG KONG – Aiming to increase the financial stability of the national health care insurance system, Japan has announced a list of 17 drugs for which prices will be reduced. The country’s Central Social Insurance Medical Council, an advisory group from the Ministry of Health, Labour and Welfare (MHLW), approved the drug repricing system on Jan. 22.
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Regulatory front for Feb. 4, 2020

Feb. 4, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GE Healthcare.
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Map of India, Pakistan, Afghanistan

India to levy cess on med-tech imports to boost domestic industry

Feb. 4, 2020
By David Ho
HONG KONG – Over the weekend, India’s Union Finance Minister Nirmala Sitharaman has imposed a health cess (also known as tax on tax) of 5% on the imports of medical equipment, except those exempted from basic customs duty (BCD). The aim of this development, stated in Sitharaman’s 2020 budget address, is to give impetus to the domestic industry and to generate resources for health services in the country.
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Regulatory front for Feb. 4, 2020

Feb. 4, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Sanofi, Glaxosmithkline, Novartis.
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Architectural pillars

Regulatory front for Feb. 4, 2020

Feb. 4, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: U.S. Department of Justice
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FDA approves Audenz to protect against influenza A (H5N1)

Feb. 4, 2020

Regulatory front for Feb. 3, 2020

Feb. 3, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Johnson & Johnson.
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Influenza A protection and a peanut allergy treatment receive FDA approvals

Feb. 3, 2020
By Lee Landenberger
The FDA has issued two new approvals, one for a cell-based pandemic influenza A (H5N1) vaccine and the other is the first approval for treating peanut allergy.
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