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BioWorld - Sunday, April 19, 2026
Home » Authors » Mari Serebrov

Articles by Mari Serebrov

FDA Questions Benefits, Risks of Amgen's Xgeva

Feb. 7, 2012
By Mari Serebrov
WASHINGTON – What do a biostatistician, pediatric oncologist, gynecology oncologist and hematology oncologist have in common?
Read More

Biopharma Speeding Down New Biosimilar Pathway

Feb. 6, 2012
By Mari Serebrov
WASHINGTON – Companies chasing down biosimilars are not letting the lack of guidance slow them down.
Read More

Congress Looks at Pediatric Incentives in BPCA, PREA Talks

Feb. 3, 2012
By Mari Serebrov
While the reauthorization of PDUFA was the focal point of a House subcommittee hearing Wednesday, lawmakers also began consideration of two acts that require and incentivize pediatric drug trials.
Read More

Multiple Rabbit Trails Mark Opening of PDUFA Hearings

Feb. 2, 2012
By Mari Serebrov
In the opening congressional hearing to reauthorize PDUFA, the discussion Wednesday ranged from the dangers of the Brazilian Blowout hair straightener to the Tobacco Control Act.
Read More

SEC Panel Recommends Exemption for Crowd-Funding

Feb. 1, 2012
By Mari Serebrov
WASHINGTON – Recognizing social media as a powerful tool that small start-ups can use to attract investors, an SEC advisory committee is advising the commission to consider an exemption from its registration requirements to permit crowd-funding.
Read More

CMS Ends Uncertainty on Rx Drug Reimbursement Policy

Jan. 31, 2012
By Mari Serebrov
WASHINGTON – After coming under fire for delaying rulemaking on prescription drug reimbursement, the Centers for Medicare & Medicaid Services (CMS) has proposed a rule to implement provisions of the 2010 Affordable Care Act (ACA) relating to manufacturer rebates and alignment of pharmacy reimbursement rates for covered outpatient prescription drugs.
Read More

FDA Back to Work on Standards For Risk Information in TV Ads

Jan. 30, 2012
By Mari Serebrov
WASHINGTON – All those drug ads on TV may eventually be required to include side-effect and contraindication information in superimposed text as well as audio.
Read More

Increased Biopharma Patent Valuation Fuels Litigation

Jan. 30, 2012
By Mari Serebrov
In an economy gasping for air, patents are increasingly becoming the oxygen of biopharma, fueling a litigation process that fans their value even more.
Read More

Social Media Is on the Trend in New FDA Guidances

Jan. 25, 2012
By Mari Serebrov
WASHINGTON – If a mention in two guidances is enough to establish a trend, social media is definitely trending at the FDA.
Read More

Push is on to Expand FDA's Accelerated Approval Pathway

Jan. 24, 2012
By Mari Serebrov
Legislation to broaden the accelerated approval path is being gussied up for its Senate debut within the next few months.
Read More
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