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Home » Authors » Mari Serebrov

Articles by Mari Serebrov

SEC Looks for Public Guidance on JOBS Act

April 16, 2012
By Mari Serebrov
WASHINGTON – The SEC has its work cut out for it in implementing the new Jumpstart Our Business Startups (JOBS) Act. But before it rolls up its sleeves, it's turning to the public for guidance.
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Looking to Raise $49M, ArQule Expands Public Stock Offering

April 12, 2012
By Mari Serebrov
On its way to the public trough, ArQule Inc. decided to go for a bigger portion, opting to increase its underwritten offering to 7.15 million shares priced at $7.30 per share.
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Facing the Patent Cliff, Pharma Clings to Blockbuster Drugs

April 10, 2012
By Mari Serebrov
Big pharma is refusing to go quietly into the night as its biggest blockbusters fall off the patent cliff, endangering more than half of some drugmakers' brand portfolios.
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Supreme Court Asked for Shareholder Class Action Rx

April 9, 2012
By Mari Serebrov
WASHINGTON – The Supreme Court is being asked to curb a growing cottage industry of shareholder lawsuits by raising the bar for class actions alleging companies have frauded the market.
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Senate's PDUFA Package Is Packing on the Weight

April 6, 2012
By Mari Serebrov
WASINGTON – Despite warnings against weighing down the PDUFA and other user fee agreements negotiated between the FDA and industry, Congress is piling on the calories with favorite menu items ranging from drug shortage notification to social media guidance.
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PDUFA Heads to Markup With A Warning to Leave it Alone

April 2, 2012
By Mari Serebrov
WASHINGTON – With more riding on the reauthorization of PDUFA than ever before, a Senate committee is pushing through a package of user fees with a warning against bogging it down with costly and controversial measures.
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EMDAC Makes CV Safety Top Priority in Obesity Drugs

March 30, 2012
By Mari Serebrov
Cardiovascular safety won out over all other risk factors and the need to encourage the development of innovative weight-loss drugs Thursday as the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 17-6 that cardiovascular outcome trials (CVOTs) should be required for all obesity drugs, even those that have no theoretic cardiovascular risk or signal.
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EMDAC Digesting Benefits, Risks of Obesity Drugs

March 29, 2012
By Mari Serebrov
Members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) got a lot to chew on Wednesday as they considered how to assess cardiovascular risks when developing drugs to treat obesity.
Read More

House Passes JOBS Act; President's Desk Next Stop

March 28, 2012
By Mari Serebrov
WASHINGTON – It's about to be a whole new ballgame for small biotechs looking to go public.
Read More

Supreme Court Sends Myriad Back for a Do-Over

March 27, 2012
By Mari Serebrov
WASHINGTON – Leaving a lot of personalized medicine claims in patent limbo, the Supreme Court Monday told an appellate court to reconsider a challenge to Myriad Genetics Inc.'s claims on the BRCA1 and BRCA2 genes, used in diagnostics for breast and ovarian cancer.
Read More
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