Pro­to­cols: Snubbed at the FDA, again, Chi­as­ma chops staff, again; J&J lands sec­ond BTD for de­pres­sion drug es­ke­t­a­mine

A few days af­ter ac­knowl­edg­ing that it was slapped down, again, by reg­u­la­tors, Chi­as­ma is chop­ping near­ly half its work­force in a sec­ond re­struc­tur­ing. Chi­as­ma CEO Mark Leucht­en­berg­er says the move to ax 44% of its re­main­ing staff was need­ed so the com­pa­ny can con­serve its cash while talk­ing to the FDA about its re­quire­ments on prov­ing the ef­fi­ca­cy of My­capssa (oc­treotide) for acromegaly. The FDA re­ject­ed My­capssa and re­cent­ly re­peat­ed a de­mand that the biotech de­sign and ex­e­cute a much bet­ter late-stage study. Reg­u­la­tors were un­hap­py with Chi­as­ma’s sin­gle arm study for a drug that is seek­ing to re­place the in­jecta­bles now in use.

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