FDA Approves APP's Abraxane Paclitaxel Formulation
American Pharmaceutical Partners will submit survival data and pharmacokinetic data in subjects with hepatic impairment for Abraxane as part of the company's Phase IV commitments. APP hopes to position Abraxane as safer and more effective than Bristol's Taxol and paclitaxel generics.
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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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The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.
Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.
Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.