Chi­na is "eat­ing our lunch" on new drug ap­provals and clin­i­cal tri­al starts, HHS Sec­re­tary Robert F. Kennedy Jr. told Con­gress Tues­day, while prais­ing the FDA's ac­tions so far.

"We are los­ing sci­en­tists, we're los­ing our IP, we're los­ing physi­cians, we're los­ing the best re­searchers, and we're go­ing to lose our biose­cu­ri­ty," Kennedy said in re­sponse to ques­tions from Rep. Brett Guthrie (R-KY) on Chi­nese in­no­va­tion.

As far as what HHS and the FDA can do to help, Kennedy said, "We're do­ing it right now. We are fast-track­ing ap­provals now in our coun­try at record lev­els. We are re­duc­ing the clin­i­cal tri­als from two tri­als to one tri­al, where ap­pro­pri­ate."

A new HIV treat­ment will soon come to mar­ket, and it will spear­head Mer­ck’s at­tempt to be one of the lead­ing drug­mak­ers in a field many biotechs have de­sert­ed.

The FDA green­lit Mer­ck’s once-dai­ly pill for adults with HIV-1 who are vi­ro­log­i­cal­ly sup­pressed, as a re­place­ment for their cur­rent an­ti­retro­vi­ral reg­i­men. The US reg­u­la­tor ap­proved Id­vyn­so on Mon­day, ac­cord­ing to an up­date to the FDA data­base on Tues­day. It came a week in ad­vance of an April 28 PDU­FA goal­post.

Id­vyn­so is a com­bi­na­tion of do­ravirine and is­la­travir. Do­ravirine is an ap­proved HIV med­i­cine known as Pifel­tro. Is­la­travir, mean­while, is be­ing stud­ied in a suite of clin­i­cal tri­als test­ing it as a com­bi­na­tion tool for once-dai­ly and week­ly treat­ment for HIV.

Adding Mer­ck’s Welireg to an ex­ist­ing Keytru­da reg­i­men didn’t lead to a sig­nif­i­cant im­prove­ment in new­ly di­ag­nosed pa­tients with ad­vanced kid­ney can­cer, Mer­ck an­nounced on Tues­day.

The re­sults mark a set­back for Mer­ck as it looks to shore up its rev­enue sources ahead of Keytru­da’s im­pend­ing patent cliff. Leerink an­a­lysts said on Tues­day that the re­sults take Welireg’s “up­side case for fill­ing the Keytru­da-rev­enue gap in ear­ly 2030s off the ta­ble.”

The tri­al, called LITES­PARK-012, stud­ied Welireg in com­bi­na­tion with Keytru­da and Ei­sai’s Lenvi­ma — a dou­blet reg­i­men that’s been ap­proved since 2021 for first-line re­nal cell car­ci­no­ma pa­tients. At a pre-spec­i­fied in­ter­im analy­sis, the triplet ther­a­py didn’t meet its dual pri­ma­ry end­points of pro­gres­sion-free sur­vival and over­all sur­vival.

SAN DIEGO — Since Her­cept­in's ap­proval in 1998, breast can­cer has been re­shaped from a near-term death sen­tence in­to — in many cas­es — a chron­ic dis­ease. Now, re­searchers hope darax­on­ra­sib from Rev­o­lu­tion Med­i­cines will launch the same type of trans­for­ma­tion in pan­cre­at­ic can­cer.

A re­cent Phase 3 find­ing on darax­on­ra­sib “is one of the most im­por­tant things that’s hap­pened in can­cer ther­a­peu­tics in the last 30 to 40 years,” Stifel health­care di­rec­tor Tim Opler said. “This is very much a Her­ceptin-type mo­ment.”

Be­fore Her­ceptin’s ap­proval, chemother­a­py was of­ten the on­ly treat­ment for breast can­cer, po­ten­tial­ly keep­ing the can­cer at bay for a few months. But the tu­mors would re­cur in most cas­es, leav­ing pa­tients with­out fur­ther op­tions.

The bleak Eu­ro­pean ap­proval po­ten­tial for Soleno Ther­a­peu­tic­s' ge­net­ic obe­si­ty drug es­sen­tial­ly forced the US drug­mak­er to sell it­self for less than it was once worth.

In a rare case, Soleno sold at a price low­er than its ini­tial buy­out of­fer, ac­cord­ing to new doc­u­ments out­lin­ing its $2.9 bil­lion deal with Neu­ro­crine Bio­sciences an­nounced ear­li­er this month. Neu­ro­crine's of­fer was rough­ly a 38% drop in per-share val­ue from an­oth­er com­pa­ny's ear­li­er of­fer in May 2025.

Soleno had se­cured an FDA nod for its Prad­er-Willi syn­drome drug and reached prof­itabil­i­ty as a sin­gle-as­set com­mer­cial biotech, but its longer-term prospects and fal­ter­ing ex­pan­sion po­ten­tial in Eu­rope led a few com­pa­nies to back out of the process, ac­cord­ing to the Mon­day SEC fil­ing.