The FDA's ex­ter­nal re­search con­duct­ed by uni­ver­si­ties, typ­i­cal­ly on com­plex pub­lic health chal­lenges, will see a re­design in the next year, HHS con­firmed to End­points News.

The pro­gram, known as the Cen­ters of Ex­cel­lence in Reg­u­la­to­ry Sci­ence and In­no­va­tion (CER­SI), brings in top uni­ver­si­ties that con­duct re­search for FDA cen­ters. For ex­am­ple, Yale has per­formed re­search on in­flu­enc­ing pre­scriber de­ci­sion-mak­ing on opi­oids for the FDA's drug cen­ter, and the Uni­ver­si­ty of Cal­i­for­nia at San Fran­cis­co (UCSF) has stud­ied off-tar­get sites for genome-edit­ed prod­ucts.

Un­der the pro­gram, the FDA part­ners with re­searchers, who each re­ceive up to $50 mil­lion over five years. Cur­rent CER­SI pro­grams in­clude Johns Hop­kins, the Uni­ver­si­ty of Mary­land, Yale and the Mayo Clin­ic, UCSF and Stan­ford, and one in Re­search Tri­an­gle Park in North Car­oli­na.

Am­gen be­came the lat­est drug­mak­er to un­veil a di­rect-to-con­sumer of­fer­ing in re­sponse to Pres­i­dent Don­ald Trump’s drug pric­ing push, an­nounc­ing Mon­day that it will sell its car­dio­vas­cu­lar med­ica­tion Repatha for a near­ly 60% dis­count off the list price.

The biotech said Mon­day that it will sell Repatha through its Am­gen­Now plat­form for $239 per month. Am­gen says the price is the low­est among fel­low G7 na­tions and is “be­ing of­fered ex­clu­sive­ly for the first time to US pa­tients.”

The an­nounce­ment re­flects the ef­fort by large drug­mak­ers to sup­port the White House’s push to sell drugs di­rect­ly to pa­tients for far less than the of­fi­cial list price. But there are doubts about how big the mar­ket for such of­fer­ings ac­tu­al­ly is, since most peo­ple use in­sur­ance to buy drugs, and those co-pays and oth­er cost-shar­ing pay­ments can be much low­er, on av­er­age, than a dis­count­ed re­tail cost.

The FDA has re­vealed a new pi­lot pro­gram, dubbed the ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA), which will en­cour­age drug­mak­ers to use do­mes­tic sup­plies of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents for gener­ic drugs.

The new pro­gram will speed up the re­view process for gener­ic drugs for drug­mak­ers who man­u­fac­ture prod­ucts in the US, ac­cord­ing to the FDA's Fri­day press re­lease. Gener­ic drugs make up about 92% of US re­tail and mail phar­ma­cy pre­scrip­tions, ac­cord­ing to a Brook­ings In­sti­tute re­port from March.

Com­pa­nies will be el­i­gi­ble for the pi­lot pro­gram if they are ex­clu­sive­ly us­ing US-based API sources, and if they con­duct any bioe­quiv­a­lence test­ing in the US.

“Over-re­liance on for­eign drug man­u­fac­tur­ing and test­ing cre­ates risks both to na­tion­al se­cu­ri­ty and pa­tient ac­cess, and un­der­mines in­vest­ments in US re­search, man­u­fac­tur­ing and pro­duc­tion,” CDER di­rec­tor George Tid­marsh said in the an­nounce­ment.

The CDC of­fi­cial­ly adopt­ed Covid-19, MMR and chick­en­pox vac­cine rec­om­men­da­tions from new ad­vi­sors that HHS Sec­re­tary Robert F. Kennedy Jr. used to re­place a long­stand­ing group of pub­lic health ex­perts.

Un­der the new rec­om­men­da­tions, the agency will now ad­vise that any­one six months and old­er con­sult a health­care provider be­fore re­ceiv­ing the Covid-19 shot. It will al­so now rec­om­mend that chil­dren un­der age 4 re­ceive the chick­en­pox vac­cine sep­a­rate­ly from a com­bined vac­cine against measles, mumps and rubel­la.

The rec­om­men­da­tions, fi­nal­ized Mon­day, were put for­ward by the Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices (ACIP) last month. In a state­ment, act­ing CDC di­rec­tor Jim O’Neil claimed that pri­or rec­om­men­da­tions, which broad­ly rec­om­mend­ed that every­one six months and old­er re­ceive a Covid-19 vac­cine an­nu­al­ly, “de­terred health care providers from talk­ing about the risks and ben­e­fits of vac­ci­na­tion for the in­di­vid­ual pa­tient or par­ent.”

Abi­vax fleshed out its big Phase 3 ul­cer­a­tive col­i­tis vic­to­ry, pre­sent­ing new analy­ses over the week­end of a past read­out that sent its stock soar­ing.

It as­sessed a pooled group of near­ly 1,300 pa­tients from two Phase 3 stud­ies, look­ing at sub­sets of pa­tients who failed pri­or treat­ment with bi­o­log­ics, JAK in­hibitors and S1P mod­u­la­tors and those who did not. Among the pa­tients who saw con­tin­ued suc­cess with pri­or treat­ment, Abi­vax said obe­faz­i­mod im­proved out­comes by 28% com­pared to place­bo at the 50 mg dose.

The re­sult was high­ly sta­tis­ti­cal­ly sig­nif­i­cant, with a p-val­ue of p<0.0001.

In pa­tients who failed their pri­or ther­a­pies, obe­faz­i­mod im­proved out­comes by 29% com­pared to place­bo. The out­come was al­so sta­tis­ti­cal­ly sig­nif­i­cant, but at a much more mod­est rate. The p-val­ue was p=0.0242.