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BioWorld - Friday, June 19, 2026
Home » Authors » Mari Serebrov

Articles by Mari Serebrov

U.S. Securities and Exchange Commission

US SEC: Impact of Russian invasion must be disclosed

May 4, 2022
By Mari Serebrov
Before filing financial statements with the U.S. SEC, public companies will need to think about how their business has been impacted by Russia’s invasion of Ukraine and, perhaps, update filings they’ve already submitted.
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Global vaccine.png

WTO’s IP waiver reaches final stretch

May 4, 2022
By Mari Serebrov
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
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WTO logo

Turkey disputes WTO findings, US 301 calls out the same bad actors

May 3, 2022
By Mari Serebrov
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
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EC takes big step in digital transformation of EU health care

May 3, 2022
By Mari Serebrov
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.”
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GSK trade secret theft a family affair

May 3, 2022
By Mari Serebrov
In an ongoing sibling saga of biopharma trade secret theft, Gongda Xue, a Swiss resident and Chinese citizen, has been convicted, following a U.S. trial, of charges related to a conspiracy to steal trade secrets from Glaxosmithkline plc over a six-year period beginning in 2010, the U.S. Attorney’s Office for the Eastern District of Pennsylvania reported May 2.
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Medicare puzzle

US CMS told to stay in its lane on coverage decisions

May 3, 2022
By Mari Serebrov
The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.
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DNA

US FDA advises on ctDNA as a biomarker for certain early stage cancers

May 2, 2022
By Mari Serebrov
The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies. 
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WTO logo

Turkey disputes WTO findings, US 301 calls out the same bad actors

April 29, 2022
By Mari Serebrov
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
Read More
FDA sign

Califf: Commissioner turnover a destabilizing force at US FDA

April 28, 2022
By Mari Serebrov
In his second stint as U.S. FDA commissioner, Robert Califf discussed the challenges in leading a massive agency that has seen seven commissioners come and go over the past 10 years.
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Becerra on the hot seat in US House budget hearing

April 27, 2022
By Mari Serebrov
Making his first in-person appearance April 27 before the House Energy and Commerce Subcommittee on Health, U.S. Health and Human Services Secretary Xavier Becerra was prepared to answer questions about President Joe Biden’s fiscal 2023 budget that would increase HHS’ discretionary budget to $127 billion, nearly a 27% increase over the 2021 enacted level.
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