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J&J Eprex EU Label Changed; FDA Investigating Manufacturing Fraud
Johnson & Johnson is recommending intravenous administration of Eprex (epoetin alfa) over subcutaneous administration in chronic renal failure patients in order to decrease the incidence of pure red blood cell aplasia in a July 17 "Dear Doctor" letter to physicians in the EU
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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 new pilot aims to take Brazil closer to ‘digital transformation.’
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A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
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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.
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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.