Withdrawal of PPA-containing cold medicines estimated to cost Bayer [Euro]60 mil. to [Euro]80 mil. ($50.9 mil. to $67.9 mil), company says during recent analysts conference. The Alka-Seltzer Plus brand was heavily impacted by FDA's Nov. 3 letter requesting that manufacturers voluntarily discontinue marketing drugs containing phenylpropanolamine. All six effervescent products in the cough/cold line contain PPA; the five Liqui-Gel products are PPA free. Bayer says it hopes to introduce reformulated effervescent products in early 2001 (1"The Tan Sheet" Nov. 13, p. 4)
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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.’
In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.
