In response to a motion filed by Lilly in Michigan Eastern District Court, Justice Department has "tentatively" consented to termination of a 35 year-old antitrust consent decree against Lilly and Warner-Lambert. The 1951 decree had settled charges that Lilly and Parke Davis fixed prices of hard gelatin capsules as well as monopolizing their production and sale. Announced Aug. 19, Justice Department's decision to lift the decree is subject to 60 day comment period.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.