No­var­tis, Gilead, GSK grab pos­i­tive CHMPs; Menar­i­ni and Ra­dius sign up to $350M part­ner­ship

→ The CHMP may have giv­en a thumbs down on SO­BI’s $568 mil­lion rare dis­ease drug, but they hand­ed out sev­er­al pos­i­tive opin­ions, in­clud­ing:

  • Gilead and Gala­pa­gos’s JAK in­hibitor fil­go­tinib was rec­om­mend­ed for mod­er­ate to se­vere rheuma­toid arthri­tis. It will be known as Jy­s­e­le­ca should it be ap­proved.
  • No­var­tis’s sick­le cell drug Adakveo, meant to re­duce the num­ber of painful sick­le cell crises, was rec­om­mend­ed for ap­proval.
  • Heron Ther­a­peu­tics’ post-op­er­a­tive pain drug HTX-011 was rec­om­mend­ed for ap­proval, de­spite be­ing slapped down by the FDA mul­ti­ple times.
  • Glax­o­SmithK­line’s an­ti­body-drug con­ju­gate be­lan­tam­ab mafodotin was rec­om­mend­ed. The an­ti-BC­MA drug was re­cent­ly rec­om­mend­ed by an FDA ad­vi­so­ry com­mit­tee for ap­proval in the US, de­spite con­cerns about safe­ty and ef­fi­ca­cy.

→ More than a year af­ter the De­part­ment of Jus­tice in­dict­ed In­di­v­ior, the Lon­don-based biotech has reached a deal to re­solve all law­suits re­lat­ed to its opi­oid treat­ment, Sub­ox­one. A sub­sidiary subbed In­di­v­ior So­lu­tions has plead­ed guilty to one count of mak­ing a false state­ment re­lat­ing to health care mat­ters in 2012, while the main com­pa­ny will pay $600 mil­lion to gov­ern­ments over 7 years.

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