Tag Archives: Novartis

Patent Filing to Drug Approval: A Difficult Journey Even for the Mighty

By Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit. The UK Financial Times this week (March 18) flagged up data from Withers & Rogers, a London-based IP firm, showing how the numbers of patent filings from the ten leading pharma companies has dropped in recent years. According to the law firm, only 129 “patent […]
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GlaxoSmithKline Recalls Antihypertensive Drug Made at Novartis Facility

By Patricia Van Arnum. GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets, according to a Feb. 22, 2012, FDA enforcement report. The lots are being recalled due to concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packing process at the Lincoln, […]
Posted in Regulatory, Safety | Also tagged , , | 1 Comment

Merck KGaA MS Drug on the Fast Track

Merck KGaA received word July 25 that its application for the multiple sclerosis treatment Cladribine had received priority review status by FDA, decreasing the evaluation period from 10 months to six months, and closing the gap between Merck and the competition. “This is a critical milestone on the path to potential approval for short-course therapy […]
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Novartis Employees Get $250 million Payout

A Federal jury in New York ruled against Novartis in a gender discrimination lawsuit, ordering the company to pay $3.36 million in compensatory damages to 12 women and $250 million in punitive damages to 5,600 others in one of the largest gender discrimination class actions in American history. The women charged that Novartis created a […]
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A Few Words About Diversification

Guest blog by Dr Brian White, an analyst at Shore Capital. As a result of the feared impact of the patent expiry cliff, the decimation of branded sales by multi-sourced generics and the obstacles erected, especially by managed care in the US, to slow the uptake of branded pharmaceuticals where a generic in the same […]
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