An FDA staff analy­sis of the safe­ty of pe­di­atric Covid-19 shots has been fi­nal­ized and sent to the agency’s vac­cine and bi­o­log­ics head Vinay Prasad. But the re­port comes to many few­er firm con­clu­sions than two of the agency’s biggest crit­ics of the vac­cines have sug­gest­ed it would.

End­points News spoke to two peo­ple with knowl­edge of the analy­sis, who said that a re­view of ad­verse event re­ports found sev­en deaths in chil­dren that are “pos­si­bly” or “prob­a­bly” re­lat­ed to the Covid-19 vac­cines. The de­scrip­tion of the deaths as pos­si­bly or prob­a­bly linked rep­re­sents an in­ter­me­di­ate lev­el of cer­tain­ty, short of a de­fin­i­tive as­sess­ment that the shots caused the deaths.

As part of a batch of rec­om­men­da­tions is­sued Fri­day, the Eu­ro­pean Med­i­cines Agency’s hu­man med­i­cines com­mit­tee (CHMP) rec­om­mend­ed re­ject­ing Anavex’s Alzheimer’s dis­ease drug, is­su­ing a scathing re­view of the pil­l's safe­ty and ef­fi­ca­cy is­sues.

The com­mit­tee said it was con­cerned that the pill, called blar­came­sine, could con­tain can­cer-caus­ing im­pu­ri­ties. In ad­di­tion, its main clin­i­cal study failed to meet its ob­jec­tive, and a “high pro­por­tion of pa­tients” stopped tak­ing the drug be­cause of cen­tral ner­vous sys­tem side ef­fects.

Last month Anavex said it planned to re­quest a re­ex­am­i­na­tion of blar­came­sine from the Eu­ro­pean reg­u­la­tors, af­ter CHMP warned a neg­a­tive opin­ion was like­ly. Anavex has 15 days to file for re­ex­am­i­na­tion.

As part of Fri­day's pack­age of ac­tions, the com­mit­tee al­so rec­om­mend­ed five new med­i­cines and 10 la­bel ex­pan­sions.

El­i­gi­ble health cen­ters pur­chased $81.4 bil­lion in dis­count­ed drugs un­der the fed­er­al 340B pro­gram in 2024, an in­crease of 23% from the pre­vi­ous year as the pro­gram con­tin­ues to ex­pand — and face le­gal chal­lenges.

The da­ta re­leased on Thurs­day cap­ture “the vast ma­jor­i­ty but not all 340B trans­ac­tions,” ac­cord­ing to the US Health Re­sources and Ser­vices Ad­min­is­tra­tion, which over­sees the 340B pro­gram.

The 340B pro­gram re­quires drug com­pa­nies to pro­vide dis­count­ed prices to health cen­ters that qual­i­fy, such as those serv­ing low-in­come or rur­al com­mu­ni­ties. Hos­pi­tals de­scribe it as a vi­tal fi­nan­cial life­line, while the phar­ma in­dus­try ar­gues that it is rife with fraud and abuse. Their fight has in­ten­si­fied in re­cent weeks as the gov­ern­ment pre­pares to im­ple­ment a con­tro­ver­sial pi­lot on Jan. 1 that would change how the pro­gram has op­er­at­ed for decades.

GSK and In­no­vi­va both won ap­provals from the FDA for their an­tibi­otics to treat gon­or­rhea, adding new tools to doc­tors' ar­se­nal amid a rise in re­sis­tance to cer­tain drugs used to treat the sex­u­al­ly trans­mit­ted bac­te­ria.

GSK's an­tibi­ot­ic, Blu­jepa, is a twice-dai­ly pill that's now ap­proved for adults and chil­dren 12 years and old­er who weigh at least 45 kg and have lim­it­ed or no oth­er op­tions to treat their dis­ease. The UK drug­mak­er said there is a “sig­nif­i­cant need” for new an­tibi­otics to fight gon­or­rhea, one of the most preva­lent sex­u­al­ly trans­mit­ted dis­eases in the US.

"The avail­abil­i­ty of ad­di­tion­al treat­ment op­tions is of par­tic­u­lar im­por­tance giv­en the glob­al rise in gono­coc­cal drug re­sis­tance,” Pe­ter Kim, who leads FDA's in­fec­tious dis­eases group in the drug di­vi­sion, said in a state­ment.

GSK has of­floaded a cor­po­rate ven­ture unit that in­vests in bio­elec­tron­ic star­tups work­ing on neu­ro­mod­u­la­tion, wear­ables, im­plant­ed de­vices and oth­er tech­nol­o­gy, End­points News has learned.

The VC unit, Ac­tion Po­ten­tial Ven­ture Cap­i­tal (APVC), launched with $50 mil­lion from GSK in 2013, when it made its first in­vest­ment in Set­Point Med­ical, cre­ator of an im­plantable de­vice to as­suage in­flam­ma­to­ry dis­eases.

“We can con­firm we have en­tered in­to an agree­ment to spin out cer­tain ven­ture cap­i­tal in­vest­ments his­tor­i­cal­ly held by GSK,” a spokesper­son for GSK said in an emailed state­ment to End­points on Thurs­day.

It's the sec­ond time GSK has sep­a­rat­ed from a cor­po­rate ven­ture cap­i­tal unit. The drug­mak­er al­so spun out its bio­phar­ma-fo­cused ven­ture unit, SR One, in No­vem­ber 2020. SR One has since raised hun­dreds of mil­lions of dol­lars, and GSK still main­tains a stake.