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BioWorld - Wednesday, February 8, 2023
Home » Authors » Mari Serebrov

Mari Serebrov

Articles

ARTICLES

Scientist injecting vaccine into Earth

Biopharma shares vision for pandemic preparedness, trial diversity

July 20, 2022
By Mari Serebrov
No Comments
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.
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Flag of the Russian Federation

Russia takes steps to ensure drug, device supplies

July 19, 2022
By Mari Serebrov
No Comments
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
No Comments
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
No Comments
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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Extending the human lifespan: Aging is not an endpoint – new regulatory, reimbursement approaches needed

July 18, 2022
By Mari Serebrov
No Comments
If anti-aging drugs are to become widely available and adopted, especially in the U.S., they have some serious hurdles to overcome. And those hurdles aren’t all in the lab or clinic. With classes of anti-aging drugs already in the pipeline, “the biggest hurdle is FDA approval. Then reimbursement,” said George Kuchel, a professor and director of the UConn Center on Aging at the University of Connecticut. Read the final installment of BioWorld’s multipart series on extending the human lifespan.
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Flag of the Russian Federation

Russia takes steps to ensure drug, device supplies

July 15, 2022
By Mari Serebrov
No Comments
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.
Read More
U.S. Supreme Court

Future of skinny-label generics rests with US Supreme Court

July 14, 2022
By Mari Serebrov
No Comments
As a last-ditch effort to preserve skinny labeling for generics, Teva Pharmaceuticals USA Inc. is asking the U.S. Supreme Court to review a Federal Circuit split opinion in Glaxosmithkline plc v. Teva Pharmaceuticals that upset the status quo of the generic marketplace.
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Flag of the Russian Federation

Russia takes steps to ensure drug, device supplies

July 14, 2022
By Mari Serebrov
No Comments
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.
Read More
Viruses

Pandemic’s unwanted gift opens opportunities for AMR vaccines

July 13, 2022
By Mari Serebrov
No Comments
COVID-19 is the unwanted gift that keeps on giving. The U.S. CDC unwrapped one of those “presents” in a July 12 report that showed the threat of antimicrobial-resistant (AMR) infections has worsened — with resistant hospital-onset infections and deaths in the U.S. each increasing at least 15% during the first year of the pandemic.
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Generic, biosimilar industry warns about cost of Build Back Better

July 12, 2022
By Mari Serebrov
No Comments
The revised Build Back Better bill Democrats in the U.S. Senate are looking to pass in the next few weeks could deliver savings of $18 billion to $24 billion per year from 2028 through 2031 through drug pricing reforms that include direct Medicare price negotiations, according to a Congressional Budget Office estimate.
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View All Articles by Mari Serebrov

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