• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Index insights
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Coronavirus
  • More reports can be found here

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Authors » Mari Serebrov

Mari Serebrov

Articles

ARTICLES

Myriad Spurs Call for PTO Moratorium on Gene Patents

Feb. 17, 2012
By Mari Serebrov
The 800-pound gorilla in the Patent and Trademark Office (PTO) hearing on genetic diagnostic tests was Myriad Genetics Inc. – even though the Salt Lake City-based company wasn't on the agenda.
Read More

The Death of ‘Innocent Until Proven Guilty’?

Feb. 16, 2012
By Mari Serebrov
Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the government. That principle has served the nation well for nearly 250 years. But now the FDA is seeking a congressional blessing to change it, under the guise of drug safety. Testifying before a House subcommittee last week, the FDA’s Janet Woodcock noted the stress placed on the agency because it bears the burden of proof when it comes to the...
Read More

Will the Supreme Court Grant Cert in Myriad Patent Case?

Feb. 16, 2012
By Mari Serebrov
WASHINGTON – The Supreme Court is set to consider Friday whether it wants the last word on the patentability of Myriad Genetics Inc.'s claims on the BRCA1 and BRCA2 genes, used in diagnostics for breast and ovarian cancer.
Read More

Congress Seeks Ways to Cut The Cost of Living with Pain

Feb. 15, 2012
By Mari Serebrov
WASHINGTON – Dealing with pain has been a routine part of life for millions of Americans. Now, it's being bumped up to a national priority with a focus on treating it as a complex disease in itself.
Read More

Biopharma Fees to Shoulder FDA 2013 Budget Increase

Feb. 14, 2012
By Mari Serebrov
WASHINGTON – If the FDA gets its way, it will see a 17 percent increase in its 2013 budget, but nearly all of that will be footed by the biopharma and food industry through new and increased user fees.
Read More

New Biosimilar Path Is Anything But Predictable

Feb. 13, 2012
By Mari Serebrov
WASHINGTON – While the package of draft guidances the FDA released last week on biosimilars held no surprises, it also was light on the specifics needed to produce predictability in the new pathway.
Read More

CF Patient Power Fuels Early Kalydeco Approval

Feb. 13, 2012
By Mari Serebrov
Early approval of a new drug is usually valued by the dollars that will be made through additional sales.
Read More

Draft Guidances Begin to Pave the Biosimilar Road

Feb. 10, 2012
By Mari Serebrov
The biosimilar pathway is beginning to take shape now that the FDA has released a package of draft guidances to pave the way.
Read More

ODAC Proves a Harsh Critic of Amgen's Xgeva in CRPC

Feb. 9, 2012
By Mari Serebrov

"Show me the benefit" was the mantra Wednesday when an FDA advisory committee critiqued the ability of Amgen Inc.'s Xgeva to prolong the time until bone metastasis in men with castration-resistant prostate cancer.

Read More

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
View All Articles by Mari Serebrov

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 11, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 11, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 8, 2025
  • 3D rendering of a molecular glue mediating the interaction between two proteins

    With surface mimicry, molecular glues shed hairpin need

    BioWorld Science
    Degradation is a therapeutic strategy that could offer possibilities to get at currently undruggable target proteins. In targeted degradation, compounds induce...
  • Abstract blue human heart with red cardio pulse line and red circle

    Capricor gets CRL for cell therapy BLA in rare disease

    BioWorld
    Capricor Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe