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

Feb. 3, 2020
By Tamra Sami
PERTH, Australia – Australian stem cell therapy company 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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Japan’s drug repricing plan to hit some top sellers

Feb. 3, 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.
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Regulatory front for Feb. 3, 2020

Feb. 3, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Vanda Pharmaceuticals.
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Brexit hourglass illustration

Brexit day arrives; industry continues to face lack of clarity as transition period begins

Jan. 31, 2020
By Nuala Moran
LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.
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EU panel CHMPions varied batch of prospective new therapies

Jan. 31, 2020
By Randy Osborne
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
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Time perception clocks

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

Jan. 31, 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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Regulatory front for Jan. 30, 2020

Jan. 30, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Jan. 29, 2020

Jan. 29, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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