Latest from Dean Rudge
The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.
Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.
Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.
Krka has reported its strongest-ever half-year results, surpassing €1bn in sales and growing EBITDA by 8%. Solid performance across most regions, particularly Eastern and Central Europe, supported stable margins and a positive full-year outlook.
The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.