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BioWorld - Sunday, January 25, 2026
Home » Authors » Mari Serebrov

Articles by Mari Serebrov

Is it Time to Stop Waiting for FDA's Social Media Guidance?

Aug. 19, 2011
By Mari Serebrov
If the FDA doesn't release its overdue guidance on social media soon, biopharma may beat it to the door with industry best practices for communicating directly with patients in interactive neighborhoods like Facebook.
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Antares: Differentiation on Crowded Biosimilar Highway

Aug. 18, 2011
By Mari Serebrov
As the biosimilar road trip gets under way, the FDA is mapping out three distinct routes – follow-ons, biosimilars and interchangeable biologics.
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OIG: More Could Be Done to Reduce Medicare Drug Prices

Aug. 17, 2011
By Mari Serebrov
WASHINGTON – Yes, Medicare Part D has produced larger than expected savings, but it might save even more if rebates on brand drugs and biologics were statutory, according to the Health and Human Services Office of Inspector General (OIG).
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Biologics Exclusivity Issue a Contentious Point in Trade Talks

Aug. 15, 2011
By Mari Serebrov
WASHINGTON – Lawmakers on both sides of the biologics exclusivity issue are arguing the debate in a new forum, international trade agreements.
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OncoSec Medical Advances Electroporation Technology

Aug. 12, 2011
By Mari Serebrov
OncoSec Medical Inc. is a lot younger than it looks, with a pipeline that would make much older start-ups envious.
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It's Deja Vu All Over Again for Adventrx's Exelbine

Aug. 11, 2011
By Mari Serebrov
Adventrx Pharmaceuticals Inc. finds itself once again requesting a meeting with the FDA so it can make its case for lung cancer drug Exelbine.
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Intercept's Climb for Diabetes Easier with $163M Alliance

Aug. 10, 2011
By Mari Serebrov
Intercept Pharmaceuticals Inc. is looking to a $163 million collaboration agreement with Les Laboratoires Servier to help it scale the mountainous challenges involved in developing a novel diabetes drug.
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Don’t Price Drugs on What the Market Used to Bear

Aug. 9, 2011
By Mari Serebrov
All those warnings about price pressures and reimbursement woes – they didn’t come from Chicken Little. The sky really could be falling for drugmakers that insist on pricing their products based on what the market used to bear. Rather than making the same old arguments about the cost of drug development, biopharma needs to understand that today’s market simply can’t bear the prices of yesterday’s bestsellers. Yes, a lot of factors are involved in drug pricing, and a lot of middle men add to the costs here in the U.S. But when it comes finger-pointing time, drugmakers tend to be...
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Generic Drugmakers Ready To Hit the Biosimilar Road

Aug. 9, 2011
By Mari Serebrov
Like their big pharma cousins, major generic drugmakers are wasting no time in hitting the biosimilar highway.
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Watchdogs Barking About Conflict-of-Interest Policies

Aug. 8, 2011
By Mari Serebrov
WASHINGTON – Fears that the FDA and National Institutes of Health (NIH) may loosen researchers' collars on conflicts of interest have government watchdogs nipping at their heels.
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