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Penelope MacRae

Latest From Penelope MacRae

Top US Court Lifts Discovery Stay On Price-Fixing

The US Supreme Court has lifted a stay on document discovery in a multi-state lawsuit in which dozens of generics companies – including Teva, Mylan and Pfizer – are accused of price fixing. The ruling will allow a swathe of documents to be released in what Connecticut’s attorney general has said is potentially “the largest cartel case” in US history.

Legal Issues United States

FDA Approves First Generic Of Daraprim

Daraprim, which saw its price jacked up by 4,000% by former drug company executive Martin Shkreli, now has a competitor with the US Food and Drug Administration’s approval of the first generic version of the nearly seven-decade-old drug used to treat a life-threatening parasitic infection known as toxoplasmosis.

Generic Drugs Approvals

Akorn Extends Lenders Standstill With Aim To Sell Company

US generics company Akorn, which has been struggling since Germany’s Fresenius walked away from a $4.3bn merger three years ago, plans to put itself up for sale under an extended standstill agreement with lenders.

Strategy United States

Sanofi API Unit Expects $1bn Sales By 2022

Sanofi has announced plans to create the world’s second-largest API manufacturer to help ease European drugmakers’ dependence on supplies of raw materials from China and India.

Strategy Europe

Bio-Thera IPO Raises $241m

Bio-Thera, which has just started selling China’s first adalimumab biosimilar rival to AbbVie’s top-selling arthritis treatment Humira, has raised $241m in an IPO on the Shanghai Stock Exchange.

Strategy China

FDA Gives Then Rescinds Clearance For Aurobindo Plant

Aurobindo Pharma shares have nosedived after the US Food and Drug Administration said an investigation into one of the Indian drugmaker’s plants was still open, days after issuing a notice giving the site the all-clear.

Manufacturing Compliance
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