GLAXO WELLCOME LANOXIN (DIGOXIN) NDA APPROVED FOR HEART FAILURE and atrial fibrillation after 61 years on the market; the NDA was approved Sept. 30. An indication for atrial flutter was dropped in the revised labeling for digoxin as recommended by FDA's Cardiovascular & Renal Drugs Advisory Committee at its May 1996 review of digoxin data ("The Pink Sheet" May 13, 1996, p. 17).
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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.’
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
