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BioWorld - Wednesday, June 17, 2026
Home » Authors » Mari Serebrov

Articles by Mari Serebrov

US drug codes due for an update

July 25, 2022
By Mari Serebrov
It was bound to happen someday. With more and more prescription drugs coming to the U.S. market, the FDA is running out of unique combinations for the 10-digit national drug code given to each product.
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Map of Europe

Russia looks to expand its influence through health care

July 22, 2022
By Mari Serebrov
Citing “the current political conditions,” Russian Minister of Health Mikhail Murashko laid out ways for Russia to strengthen its international role in the health care sector, including the development of innovative radiopharmaceuticals. Other promising opportunities involve the improvement of drug provision and an increase in the number of foreign students in Russian medical universities, Murashko said at a July 19 meeting with medical, educational and scientific institutions in Russia.
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Russia looks to expand its influence through health care

July 21, 2022
By Mari Serebrov
Citing “the current political conditions,” Russian Minister of Health Mikhail Murashko laid out ways for Russia to strengthen its international role in the health care sector, including the development of innovative radiopharmaceuticals.
Read More
FDA sign

US FDA churns out more draft guidance

July 21, 2022
By Mari Serebrov
As part of its drug competition action plan, the U.S. FDA issued a draft guidance on the evaluation of therapeutic equivalence.
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Future of two cancer drugs on the line at upcoming ODAC meeting

July 21, 2022
By Mari Serebrov
Continuing its evaluation of cancer drugs already on the U.S. market, the FDA will convene its Oncologic Drugs Advisory Committee (ODAC) Sept. 22 and 23 to consider two more approved drugs – Oncopeptides AB’s Pepaxto (melphalan flufenamide) and Secura Bio Inc.’s Copiktra (duvelisib).
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IFPMA looks beyond IP to prepare for future pandemics

July 20, 2022
By Mari Serebrov
After political leaders across the globe made patents and other intellectual property (IP) safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
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Scientist injecting vaccine into Earth

Biopharma shares vision for pandemic preparedness, trial diversity

July 20, 2022
By Mari Serebrov
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
Read More
Flag of the Russian Federation

Russia takes steps to ensure drug, device supplies

July 19, 2022
By Mari Serebrov
Amid the ongoing war Russia is waging in Ukraine, representatives of several Western biopharma and medical device companies met with Russian health officials this week to discuss an uninterrupted drug supply, maintenance of medical equipment in Russia and software updates. Russian Minister of Health Mikhail Murashko told the group his agency’s top priority is an uninterrupted drug supply. He recognized that dialogue between the government and manufacturers is necessary to maintain that supply.
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Woman receiving COVID-19 vaccine

ACIP sees opportunity for Novavax in vaccine hesitancy

July 19, 2022
By Mari Serebrov
Although it’s a latecomer to the COVID-19 pandemic in the U.S., there is a wedge of opportunity for Novavax Inc.’s adjuvanted protein-based vaccine among the 10% of the U.S. adult population that has yet to get a first jab.
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U.S. Capitol building

User fee dream a nightmare in the making?

July 18, 2022
By Mari Serebrov
A “clean” user fee bill with no congressionally added policy riders. It’s been a biopharma and med-tech dream for years. But now that U.S. Sen. Richard Burr (R-N.C.) has introduced such a bill, it could prove a nightmare, given competing legislation and the tight timetable for reauthorizing the user fee programs before the clock winds down on the current agreements Sept. 30 when fiscal 2022 ends.
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