Well in­to the first cold and flu sea­son with Robert F. Kennedy Jr. as leader of HHS, vac­cine rev­enue and up­take are down while fed­er­al health of­fi­cials con­tin­ue to scru­ti­nize their val­ue.

Fol­low­ing third-quar­ter earn­ings, the gen­er­al con­sen­sus among vac­cine mak­ers for Covid-19, flu and RSV is that damp­en­ing de­mand has shrunk sales. Mod­er­na’s net prod­uct sales fell al­most 50% in the lat­est quar­ter com­pared to 2024. Pfiz­er sim­i­lar­ly record­ed a 19% drop in sales of its Covid-19 vac­cine, Comir­naty, in the third quar­ter.

Flu vac­cine mak­ers haven’t fared any bet­ter. GSK saw a 24% de­cline in its flu port­fo­lio in the third quar­ter, and Sanofi re­port­ed dou­ble-dig­it per­cent­age de­clines.

Seat­tle-based Lu­men Bio­science co-founder and CEO Bri­an Fin­row does­n't want to just bring down the cost of man­u­fac­tur­ing an­ti­bod­ies. He wants to cut it to a tiny frac­tion of the cur­rent price, and al­low the com­mon­ly in­fused or in­ject­ed treat­ments to be in­gest­ed as pills.

Fin­row and his team of about 100 em­ploy­ees are work­ing on a new way to man­u­fac­ture pro­teins in an ed­i­ble blue-green al­gae called spir­uli­na, rather than in typ­i­cal E. coli or Chi­nese ham­ster ovary cells.

The De­fense De­part­ment is cur­rent­ly fund­ing the com­pa­ny's first Phase 3 tri­al, of a ther­a­peu­tic made in spir­uli­na. The study, with re­sults ex­pect­ed in June, is fo­cused on a treat­ment for C. dif­fi­cile in­fec­tions. It's based on an old­er Mer­ck drug called Zin­pla­va.

Ab­b­Vie and No­var­tis can con­tin­ue chal­leng­ing a Utah law that reg­u­lates how drug­mak­ers dis­trib­ute 340B dis­counts, a fed­er­al court held.

The rul­ing is an­oth­er small win for the phar­ma in­dus­try as it fights across cir­cuits to knock down state 340B laws. States have pre­vailed in a ma­jor­i­ty of cas­es so far, but Wednes­day’s de­ci­sion marks Ab­b­Vie’s sec­ond vic­to­ry this month.

The dis­trict court de­nied Utah’s bid to ful­ly toss com­plaints from Ab­b­Vie, No­var­tis and the trade group PhRMA. It said the plain­tiffs ad­e­quate­ly al­leged the state law is pre­empt­ed by the fed­er­al 340B statute.

Ab­b­Vie al­leges that the state law, which took ef­fect in May, “dras­ti­cal­ly ex­pands” drug­mak­ers’ oblig­a­tions to pro­vide 340B drug dis­counts to en­ti­ties be­yond what Con­gress set out in fed­er­al law. The court says it agrees.

To help bio­phar­ma com­pa­nies ad­vance ther­a­pies more quick­ly and bet­ter un­der­stand what the FDA is ask­ing for, the agency is now al­low­ing com­pa­nies to email one clar­i­fi­ca­tion ques­tion af­ter a meet­ing.

The FDA said its Of­fice of New Drugs staff will aim to re­spond to com­pa­nies' ques­tions by email with­in three busi­ness days un­der a pi­lot pro­gram launched last month. The agency not­ed that it has al­ready pro­vid­ed "sev­er­al help­ful clar­i­fi­ca­tions to spon­sors" fol­low­ing re­ceipt of FDA meet­ing min­utes.