Mithra says its new oral contraceptive could be a major breakthrough in a “space where there hasn’t been any innovation in decades."
Estelle (estetrol/drospirenone), the novel combined oral contraceptive that Mithra is hoping will become a blockbuster product, is among nine new drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing authorization.
The EMA added the contraceptive to its latest monthly
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
