De­moc­rats in both the House of Rep­re­sen­ta­tives and the Sen­ate are ask­ing the US Patent and Trade­mark Of­fice (PTO) to take a clos­er look at Mer­ck’s pend­ing patents for its megablock­buster can­cer drug Keytru­da.

Sen. Eliz­a­beth War­ren (D-MA)’s of­fice an­nounced Thurs­day that the sen­a­tor, along­side Sen­ate Health com­mit­tee chair Bernie Sanders (I-VT) and Reps. Katie Porter (D-CA) and Prami­la Jaya­pal (D-WA), wrote a let­ter to PTO di­rec­tor Kathi Vi­dal on Wednes­day — ask­ing Vi­dal to scru­ti­nize any new patent re­quests from Mer­ck for Keytru­da, which hauled in $20.9 bil­lion last year.

The law­mak­ers ac­cused the phar­ma gi­ant of us­ing the US patent sys­tem to pro­tect its mo­nop­oly on the drug, say­ing that Mer­ck’s at­tempts to patent a sub­cu­ta­neous for­mu­la­tion of Keytru­da is akin to “ex­tend­ing its mo­nop­oly pow­er over the drug” and seems to be an ex­am­ple of an­ti-com­pet­i­tive busi­ness prac­tices.

“What ac­tions will USP­TO take to en­sure that Mer­ck’s at­tempt to seek dozens of patents ‘does not un­nec­es­sar­i­ly de­lay get­ting gener­ic, biosim­i­lar and more af­ford­able ver­sions of those drugs in­to the hands of Amer­i­cans who need them?’” the politi­cians added, say­ing that the patent of­fice should re­ject any of Mer­ck’s patent re­quests “that do not clear­ly meet the agency’s stan­dards of nov­el­ty, util­i­ty, and non-ob­vi­ous­ness.”

A Mer­ck spokesper­son told End­points News in re­sponse to the let­ter that “Mer­ck is con­tin­u­ous­ly in­no­vat­ing to en­hance the ben­e­fits of Keytru­da in or­der to reach greater num­bers of pa­tients and to in­crease ef­fi­ca­cy and con­ve­nience of the treat­ment.”

The spokesper­son added, “When ap­pro­pri­ate, Mer­ck pro­tects this ad­di­tion­al in­no­va­tion through the fil­ing of patent ap­pli­ca­tions, par­tic­u­lar­ly when we view the in­no­va­tion as nov­el, use­ful and nonob­vi­ous.”

War­ren and Sanders have spo­ken out against the phar­ma­ceu­ti­cal in­dus­try be­fore.

More re­cent­ly, War­ren asked the Fed­er­al Trade Com­mis­sion to in­ves­ti­gate cer­tain phar­ma buy­out deals last month — no­tably Am­gen’s $28 bil­lion plan to take over Hori­zon Ther­a­peu­tics and In­di­v­ior’s pro­posed ac­qui­si­tion of Opi­ant for $145 mil­lion up­front. The sen­a­tor, in a let­ter to FTC chair Lina Khan and two of the com­mis­sion­ers, called the deals “ram­pant con­sol­i­da­tion in the phar­ma­ceu­ti­cal in­dus­try.”

Sanders, a long-time crit­ic of the phar­ma­ceu­ti­cal in­dus­try and new­ly-tapped chair­man of the Sen­ate Com­mit­tee on Health, Ed­u­ca­tion, La­bor and Pen­sions (HELP), has been proac­tive in his cri­tiques of in­dus­try. The sen­a­tor re­cent­ly con­demned re­port­ed plans from Covid vac­cine gi­ant Mod­er­na to price its vac­cine be­tween $110 and $130 per dose in the US, a 300% in­crease, and has plans to grill Mod­er­na CEO Stephane Ban­cel next month.

“The huge in­crease in price that you have pro­posed will have a sig­nif­i­cant­ly neg­a­tive im­pact on the bud­gets of Med­ic­aid, Medicare and oth­er gov­ern­ment pro­grams that will con­tin­ue cov­er­ing the vac­cine with­out cost-shar­ing for pa­tients,” Sanders wrote at the time.

Mod­er­na lat­er said peo­ple won’t need to pay out-of-pock­et for its Covid vac­cine, re­gard­less of in­sur­ance sta­tus.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.