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Home » Authors » Mari Serebrov

Mari Serebrov

Articles

ARTICLES

Will ESA Spectre Haunt Affymax Anemia Drug?

Dec. 6, 2011
By Mari Serebrov
The ghost of anemia drugs present could haunt Affymax Inc.'s peginesatide injection when it comes up for discussion Wednesday at a meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC).
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CBO Forecasts Cloudy Skies For Pediatric Exclusivity

Dec. 5, 2011
By Mari Serebrov
WASHINGTON – With the sun setting next year on two major pediatric drug acts, a debate over pediatric exclusivity hovers on the horizon.
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What's Missing in This REMS? Credible Patient-Outcome Data

Dec. 2, 2011
By Mari Serebrov
Determining whether a risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) is doing the job is proving to be quite a challenge in the absence of definitive, comparative patient-outcome data.
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Solving Shortages Critical to Development of New Drugs

Dec. 1, 2011
By Mari Serebrov
WASHINGTON – With the nation's drug shortage crisis depriving patients of critical treatments and threatening the development of new drugs, lawmakers must address the root causes of the problem – government pricing and regulatory policies that have created a "race to the bottom," a House subcommittee was told.
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FDA to Tap Experts for Advice on Toughest REMS

Nov. 30, 2011
By Mari Serebrov
Making risk evaluation and mitigation strategies (REMS), especially those with elements to assure safe use (ETASU), more effective and less burdensome is a tall order. So the FDA is turning to the experts for advice on assessing those REMS.
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GAO Prescribes Ways to Prevent Drug Adulteration

Nov. 29, 2011
By Mari Serebrov
WASHINGTON – When it comes to the economic adulteration of drugs, an ounce of prevention could end up costing the biopharma industry what it considers confidential information.
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Macrocycles: Going Where No Drugs Have Gone Before

Nov. 28, 2011
By Mari Serebrov
Big pharma and biotech start-ups have embarked on a federated mission to explore the expansive chemical space between small molecules and biologics to seek out new therapies that will boldly go where no drugs have gone before.
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Portola Ready to Fly Solo On Pivotal Betrixaban Trial

Nov. 22, 2011
By Mari Serebrov
Having raised $89 million in its latest financing round, Portola Pharmaceuticals Inc. is preparing to fly solo on its pivotal Phase III trial that will evaluate betrixaban in the prevention of pulmonary embolisms.
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FDA Pulls Breast Cancer Indication for Avastin

Nov. 21, 2011
By Mari Serebrov
WASHINGTON – Citing a lack of proof that the benefits outweigh the risks, FDA Commissioner Margaret Hamburg revoked the agency's approval of the breast cancer indication for Genentech Inc.'s Avastin.
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Lawmakers Target Drug Prices With Ramped-up Competition

Nov. 18, 2011
By Mari Serebrov
With drug prices continuing their upward climb, several senators are launching bipartisan efforts to shoot them down with increased competition. And that's putting pay-for-delay settlements at the center of congressional crosshairs.
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View All Articles by Mari Serebrov

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