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Home » Topics » Regulatory

Regulatory
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Proxalutamide study once again in Brazilian crosshairs

Aug. 30, 2022
By Mari Serebrov
Brazilian regulatory agency Anvisa reported that it is participating in an investigation that launched Aug. 25 into alleged crimes of smuggling, misrepresenting, distributing and delivering proxalutamide related to a clinical trial in Brazil.
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China and U.S. flags

China agrees to ground-leveling PCAOB inspections

Aug. 30, 2022
By Mari Serebrov
For the first time since they’ve had access to U.S. capital, biopharma and med-tech companies based in China and Hong Kong are having to comply with the same accountability standards companies in the U.S. and other countries must follow as a condition of trading on U.S. markets.
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Pills under magnifying glass

Time to identify notorious markets selling counterfeits

Aug. 30, 2022
By Mari Serebrov
It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy.
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Regulatory actions for Aug. 30, 2022

Aug. 30, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rafa Laboratories.
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Natural killer cell

Japan’s Healios advances its iPSC-derived gene engineered killer cells toward the clinic

Aug. 30, 2022
By Tamra Sami
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
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Regulatory actions for Aug. 30, 2022

Aug. 30, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bluebird, Innovent, Moderna, Pfizer, Pharmazz, Plus, Polpharma, Tracon.
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Immune

Stemcyte cleared to study umbilical cord blood stem cell therapy for post-COVID syndrome

Aug. 30, 2022
Stemcyte Inc. has received IND approval from the FDA for a phase II trial using umbilical cord blood stem cell therapy for post-COVID syndrome, or long COVID.
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Generic drugs and bottle

‘Skinny labels’ at forefront of possible Supreme Court biopharma cases

Aug. 29, 2022
By Mari Serebrov
If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts.
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Regulatory actions for Aug. 29, 2022

Aug. 29, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galaxy Medical, Neuronetics, Serpex Medical.
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Regulatory actions for Aug. 29, 2022

Aug. 29, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Inhibikase, Novavax, Pfizer.
Read More
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