Posts Tagged ‘biotechnology’

FDA Finalizes Biosimilar Guidance

Thursday, April 30th, 2015

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents.

You can find the article here.

Genetic Engineering Makes the Blacklist

Thursday, April 16th, 2015

iStock_000003273676_LargeJames Spader was quirkily funny as Denny Crane’s partner on “Boston Legal,” but NBC’s “The Blacklist” has him operating totally outside of the law. He plays Raymond Reddington, an enigmatic figure who reveals to a black-ops FBI agent the evil doings of criminals that fly under the radar of normal law enforcement – and who make “The Blacklist.” A recent episode involved trying to catch a “mad scientist,” funded by a middle-aged tech billionaire to conduct research on human subjects for his “Longevity Initiative.” When the scientist is captured, oddly, one might think, his lab contains tanks of phosphorescent jelly fish and two bunnies that glow in the dark.

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Enzo Biochem V. Applera Corp. – When “Words Can Hurt You”

Thursday, March 19th, 2015

iStock_000010676885_SmallOn March 16, 2015 (Appeal no. 2014-1321), the Fed. Cir. reversed the district court’s construction of a claim term relating to the scope of “A,” a moiety capable of direct or indirect signaling that is attached by a linker to a nucleotide base. (A copy of the decision can be found at the end of this post.) The claim read: “wherein A comprises at least one component of a signaling moiety capable of producing a detectable signal [wherein the linker does not interfere] with formation of the signaling moiety or detection of the detectable signal….”

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Novartis Wins Landmark Biosimilar Approval

Monday, March 9th, 2015

iStock_000013653107_SmallNovartis Navigates The FDA-ACA Maze – Gets Approval For Generic Neuprogen.

Amgen will soon find itself in a price war with Sandoz – a Novartis company – as it tries to maintain its share of the market for Neuprogen (filgraslim). The drug is used to treat neutropenia –often a side effect of anti-rejection drugs or chemotherapy. No matter what you think of “Obamacare,” whoever slipped in a relatively small section authorizing biosimilar products and outlining a pathway to approval, may end up saving many consumers much more than they might realize from affordable health care. Sandoz will market the drug as Zarxio. Read more here.