Rick Paz­dur, the head of the FDA's drug of­fice, has tak­en steps to leave the agency just weeks af­ter tak­ing the new role, ac­cord­ing to a per­son fa­mil­iar with the mat­ter.

Paz­dur is a long­time FDA vet­er­an who be­came di­rec­tor of the agen­cy's Cen­ter for Drug Eval­u­a­tion and Re­search, al­so known as CDER, last month. He took the job on­ly af­ter sig­nif­i­cant lob­by­ing by Com­mis­sion­er Mar­ty Makary, and then clashed with Makary over sev­er­al of the agen­cy's pri­or­i­ties with­in just a few weeks.

His ex­it is­n't yet fi­nal, though he has filed pa­per­work to re­tire, ac­cord­ing to the source, who spoke on con­di­tion of anonymi­ty. It would be yet an­oth­er change in top per­son­nel at an agency be­set by ma­jor shifts in lead­er­ship un­der Makary.

Some of the biggest names in on­col­o­gy R&D have been qui­et­ly con­sol­i­dat­ing as­sets, mon­ey and pro­grams un­der a new start­up called Medici Ther­a­peu­tics, End­points News has learned.

The stealthy star­tup's back­ers in­clude two of the biggest names in biotech and can­cer: the Park­er In­sti­tute for Can­cer Re­search (PI­CI) and ARCH Ven­ture Part­ners. Ac­cord­ing to two sources, Medici re­cent­ly ac­quired Nut­crack­er Ther­a­peu­tics, which is de­vel­op­ing per­son­al­ized RNA-based med­i­cines and has raised more than $200 mil­lion from ARCH and oth­er in­vestors.

Medici's ex­is­tence has been men­tioned briefly in a hand­ful of reg­u­la­to­ry and sci­en­tif­ic doc­u­ments, but the scope of its ac­tions and am­bi­tions has­n't been pre­vi­ous­ly re­port­ed. A spokesper­son for the start­up de­clined to say how much mon­ey it's raised.

It has tak­en near­ly 30 years, but Cy­to­ki­net­ics is on the cusp of its first-ever ap­proval.

Wall Street re­gards afi­camten — a twice-dai­ly pill for a heart con­di­tion — as a fu­ture block­buster, and many will be watch­ing close­ly to see how much of a suc­cess the biotech can make of its first for­ay in­to the com­mer­cial sphere.

The drug’s jour­ney was not straight­for­ward. It is in­tend­ed to treat ob­struc­tive hy­per­trophic car­diomy­opa­thy (oHCM), a dis­or­der in which the heart mus­cle be­comes thick­ened, im­pair­ing con­trac­til­i­ty. The com­ing FDA ap­proval de­ci­sion, due by Dec. 26, is based on da­ta from a tri­al called SE­QUOIA-HCM, which emerged two years ago and were good enough to spur talk of a takeover.

He­licore Bio­phar­ma’s plans to quick­ly get in­to the obe­si­ty drug race have end­ed less than 12 months af­ter the star­tup's launch.

The com­pa­ny emerged in Jan­u­ary with a $65 mil­lion Se­ries A round that was meant to back the drug, a GIP an­tag­o­nist known as HCR-188. It be­gan a Phase 1 tri­al in Aus­tralia in March and said it would have safe­ty da­ta be­fore the end of this year.

In­stead, the Cal­i­for­nia-based start­up has sus­pend­ed the tri­al, ac­cord­ing to an up­date to the US fed­er­al tri­als reg­istry. Ac­cord­ing to a spokesper­son, it will shift its at­ten­tion from HCR-188, a mon­o­clon­al an­ti­body, to its pre­clin­i­cal pipeline of in­cretin con­ju­gates.