Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Pharma Business News
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FDA Law Blog reported Monday that the proposed follow-on biologics legislation is in serious jeopardy in Congress. Pharmalot had a similar report last Friday. Meanwhile, European regulators recently granted approval to three new biosimilar drugs, as Patent Docs reports today. The San Francisco Chronicle recently published a nice article summarizing the debate over generic biotech…
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Last week, the U.S. District Court for the District of Columbia denied Mylan’s emergency motion for a temporary restraining order that would have forced FDA to relist Pfizer’s Norvasc patent in the Orange Book. Until June 22, when FDA delisted Pfizer’s patent, Mylan and Apotex had the only approved ANDAs for generic Norvasc. Bloomberg reported…
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On Monday, the Supreme Court followed the Solicitor General’s advice and denied certiorari in Joblove v. Barr Labs, which concerned the legality of a "reverse payment" settlement of Hatch-Waxman litigation. Last year, the Court denied certiorari in a similar case, FTC v. Schering. Dow Jones reports that the FTC has vowed to press forward in…
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Pharmalot had this post Friday about a new bipartisan follow-on biologics bill in the Senate. MarketWatch reported Friday that European regulators have moved a step closer to approving Sandoz’s follow-on version of J&J’s blockbuster Eprex, sold in the U.S. as Procrit. On Thursday, a House committee marked up the PDUFA reauthorization legislation (Pharmalot). PhRMA reacted…
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In a May 14 Order, the district court in D.C. denied all motions for reconsideration of its April 30 decision on Norvasc pediatric and 180-day exclusivity. FDA Law Blog has all the reconsideration briefs. Apotex and Mylan have now appealed to the D.C. Circuit. The In Vivo Blog reports that "Democratic and Republican staffers involved…
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Norvasc update: FDA Law Blog reports that the district court has extended FDA’s deadline and that Zydus has filed a new citizen petition. Pharmalot reports on Barr Labs’ efforts to protect its Seasonale oral contraceptive from generic competition. The WSJ Health Blog summarizes today’s front-page WSJ article on Amgen’s recent troubles. The Business Standard and…
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PhRMA held its annual meeting today and yesterday in Washington. So far, there seems to be relatively little news coming out of the meeting–at least compared to GPhA’s annual meeting earlier this month. Links to a few stories are provided below; I’ll add more as I find them: March 16 article in the Star-Ledger of…
Orange Book Blog 