HHS told the Sec­ond Cir­cuit that Boehringer In­gel­heim’s vol­un­tary par­tic­i­pa­tion in Medicare ne­go­ti­a­tions “un­der­mines” its le­gal chal­lenge to the process.

Vol­un­tari­ness was a key fac­tor in the low­er court's de­ci­sion to toss Boehringer’s case in Ju­ly. The is­sue has al­so fea­tured promi­nent­ly in oth­er cas­es be­ing ar­gued across the coun­try. Be­cause Boehringer had the op­tion not to par­tic­i­pate in Medicare ne­go­ti­a­tions, the dis­trict court found that the process did not con­sti­tute a tak­ing of prop­er­ty or vi­o­la­tion of speech.

The gov­ern­ment on Wednes­day urged the US Court of Ap­peals for the Sec­ond Cir­cuit to up­hold that de­ci­sion. It ar­gued in a court brief that “eco­nom­ic in­cen­tives for man­u­fac­tur­ers to par­tic­i­pate in Medicare and Med­ic­aid do not make such par­tic­i­pa­tion in­vol­un­tary.”

The EMA's hu­man med­i­cines com­mit­tee rec­om­mend­ed 114 med­i­cines for ap­proval in 2024, mark­ing the high­est num­ber of pos­i­tive opin­ions is­sued in 15 years, ac­cord­ing to the reg­u­la­tor’s lat­est re­port.

Of the 114 rec­om­men­da­tions, 46 were for new ac­tive sub­stances, the EMA’s chief med­ical of­fi­cer Stef­fen Thirstrup said at a press con­fer­ence on Thurs­day. Can­cer re­mained the ther­a­peu­tic area with the most ap­provals in 2024, fol­lowed by im­munol­o­gy, rheuma­tol­ogy, blood and co­ag­u­la­tion dis­or­ders, and en­docrinol­o­gy, he added.

Thirstrup high­light­ed sev­er­al pos­i­tive opin­ions is­sued last year that he said helped ad­dress un­met needs, in­clud­ing one for Mer­ck’s Welireg for a rare con­di­tion called von Hip­pel-Lin­dau dis­ease that is char­ac­ter­ized by tu­mors and cysts that can turn can­cer­ous.

Rob Califf of­fi­cial­ly ends his tenure as FDA com­mis­sion­er on Mon­day, but in his fi­nal me­dia event, he stressed that the US is still strug­gling to fight mis­in­for­ma­tion on­line.

"I'm afraid that my con­clu­sion right now is that we're los­ing the bat­tle on mis­in­for­ma­tion," Califf said, adding that he's not talk­ing specif­i­cal­ly about FDA, but "all of us, in­clud­ing the main­stream press."

Com­bat­ing mis­in­for­ma­tion has been cen­tral to his tenure un­der the Biden ad­min­is­tra­tion, as he pub­li­cized his in­tent to fight it, par­tic­u­lar­ly around Covid-19 vac­cines and oth­er med­ical prod­ucts.

Speak­ing as part of an hour-long me­dia call to close out his sec­ond run as FDA com­mis­sion­er, he said mis­in­for­ma­tion is win­ning be­cause of "this in­ter­sec­tion of so­cial me­dia and cul­tur­al changes that have hap­pened, and it threat­ens a lot of the ba­sis for pub­lic health."

The rise of GLP-1s has made treat­ing obe­si­ty one of the largest mar­ket op­por­tu­ni­ties in his­to­ry. It al­so has re­in­forced a detri­men­tal re­la­tion­ship be­tween phys­i­cal health and size, ac­cord­ing to one phar­ma ex­ec­u­tive.

"Un­for­tu­nate­ly, our so­ci­ety is ob­sessed with phys­i­cal im­age,” Manu Chakravarthy, Roche’s head of car­diometa­bol­ic and re­nal prod­uct de­vel­op­ment, said on the side­lines of the JP Mor­gan Health­care Con­fer­ence.

His com­men­tary was part of a more spe­cif­ic con­cern that the re­ac­tion to new GLP-1 da­ta is hy­per­fo­cused on weight loss, and not oth­er mea­sures of health that the drugs could be im­prov­ing. Roche's ear­ly ef­fi­ca­cy from two can­di­dates has been rel­a­tive­ly on par with its peers, but in­vestors did­n't re­ward the com­pa­ny in Sep­tem­ber da­ta re­leas­es, due to side ef­fects and not quite match­ing pri­or No­vo Nordisk da­ta.

No­var­tis is the lat­est drug­mak­er to sue the gov­ern­ment for al­leged­ly re­ject­ing its pro­posed mod­el to dis­trib­ute fed­er­al drug dis­counts.

The law­suit marks the fifth drug­mak­er to chal­lenge HHS’ Health Re­sources and Ser­vices Ad­min­is­tra­tion over its re­fusal to let com­pa­nies shift to a re­bate mod­el un­der the 340B drug dis­count pro­gram. No­var­tis filed its com­plaint Wednes­day in the US Dis­trict Court for the Dis­trict of Co­lum­bia.

The 340B pro­gram re­quires drug­mak­ers to of­fer steep dis­counts to cov­ered en­ti­ties, which pri­mar­i­ly serve low-in­come pa­tients. No­var­tis, Sanofi, Eli Lil­ly and oth­ers have pro­posed the re­bate mod­els in an ef­fort to re­duce al­leged abus­es and du­pli­cate dis­count­ing with­in the sys­tem.