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Home » Authors » Mari Serebrov

Mari Serebrov

Articles

ARTICLES

BMS Opts to Keep MATCH Burning with Tranzyme Pharma

Nov. 9, 2011
By Mari Serebrov
The match Tranzyme Pharma Inc. struck with Bristol-Myers Squibb Co. (BMS) two years ago will continue to spark the discovery of potential new macrocyclic drug candidates – at least for an additional six months.
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Despite Bumper Year, BLA Approvals Down in FY2011

Nov. 7, 2011
By Mari Serebrov
WASHINGTON - Fiscal 2011 produced a bumper crop of new drug approvals with historic breakthroughs in a number of areas. But the yield on biologics actually dropped.
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Shorter Exclusivity Could Carry a Hefty Price Tag

Nov. 7, 2011
By Mari Serebrov
If successful, efforts to reduce the 12 years of data exclusivity granted under the Affordable Care Act for innovative biologics could prove to be costly for patients, payers and the companies that make the drugs.Reducing data exclusivity to seven years, as the president and a number of lawmakers have proposed, would be disruptive to the marketplace as it would encourage at-risk launches of biosimilars and lead to unnecessary patent litigation, said Dave Fox, former associate chief counsel for drugs at the FDA and a partner at Hogan Lovells.
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Amylin Loses Preliminary Round of Lilly Fight over Byetta

Nov. 3, 2011
By Mari Serebrov
Amylin Pharmaceutical Inc. lost its preliminary bid to block Eli Lilly and Co. from jointly promoting diabetes drugs Byetta and Tradjenta, but its underlying challenge to Lilly's marketing strategy has yet to get its day in court.A U.S.
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FDA Lays Out Strategy to Respond to Drug Shortages

Nov. 1, 2011
By Mari Serebrov
WASHINGTON – In trying to identify the culprit for the drug shortage crisis facing the nation, the Department of Health & Human Services (HHS) had only to look to the marketplace. But finding a solution isn't as easy.Patent expirations, a rush to generic drugs, manufacturing capacity limitations, pricing issues and expanding use of oncology drugs have combined to create a record number of shortages in off-patent sterile injectables, according to a new report from the Office of the Assistant Secretary for Planning and Evaluation at HHS.
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Patient Portal & Services Help Shire Launch HAE Drug Firazyr

Oct. 31, 2011
By Mari Serebrov
No Abstract
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House Adds its Own Reforms to U.S. Patent Reform Bill

Oct. 31, 2011
By Mari Serebrov
WASHINGTON – The biotech industry isn't so sure about the spin the House is putting on the America Invents Act, which aims to reform the U.S. patent system by placing it on a first-to-file basis like the rest of the world.
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PhRMA: Drug Pipeline for Rare Diseases is Not Running Dry

Oct. 31, 2011
By Mari Serebrov
WASHINGTON – Instead of running dry, the drug pipeline for rare diseases may be flowing with hope. As of last month, more than 450 drugs were in clinical trials for rare diseases or awaiting FDA approval.
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BIO: Small Biotechs Need Help with Overseas Patent Costs

Oct. 31, 2011
By Mari Serebrov
WASHINGTON – By providing international patent assistance to small biotechs, the U.S.
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ViroPharma's DuoCort Buy Hinges on Orphan Approval

Oct. 28, 2011
By Mari Serebrov
A lot is riding on the European approval of Plenadren. For patients with adrenal insufficiency, it could be the first innovative treatment in more than half a century. And for DuoCort Pharma AB, it could be a payday of up to nearly $165 million.That's how much ViroPharma Inc.
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View All Articles by Mari Serebrov

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