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BioWorld - Monday, December 29, 2025
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Regulatory front for March 4, 2020

March 4, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: Merck & Co., Outlook Pharmaceuticals.


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Architectural pillars

Regulatory front for March 3, 2020

March 3, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: FDA, Yibin Lihao Bio-technical.


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Brexit scissors illustration

With Brexit split, Australia ready with back-up plan for drugs and devices following transition

March 3, 2020
By Tamra Sami
PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends.
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Singapore’s Tessa gains U.S. RMAT designation for CD30 CAR T, expands manufacturing efforts

March 3, 2020
By David Ho
HONG KONG – Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy designation by the U.S. FDA based on data from two independent phase I/II trials.
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Regulatory front for March 3, 2020

March 3, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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3-3-Xatek-clotchip.png

Xatek wins breakthrough status for portable clotting sensor

March 3, 2020
By Meg Bryant
With trauma patients and those suffering from bleeding disorders, being able to quickly assess a person’s bleeding risk can be lifesaving, but most current tests to measure clotting ability are laboratory-based and don’t provide immediate results. To that end, the U.S. FDA has granted Cleveland-based Xatek Inc. breakthrough device designation for its Clotchip portable blood clotting sensor.
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Map of Argentina

Argentina’s medical device industry gets a boost with MDSAP membership

March 3, 2020
By Sergio Held
BOGOTA, Colombia – Argentina is the latest member of an international medical devices regulatory group. Joining the group could help the country speed up approvals and help the market for medical technology improve.
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India’s restriction on API exports gives rise to more calls for U.S. drug, device manufacturing

March 3, 2020
By Mari Serebrov
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
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Regulatory front for March 3, 2020

March 3, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Bluebird Bio, Novartis.
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Sarclisa receives FDA approval for relapsed refractory multiple myeloma

March 3, 2020
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