In­cyte fi­nal­ly has some good news to share about one drug it’s dis­cov­ered that’s not Jakafi — al­beit one that doesn’t be­long to it any­more.

FDA reg­u­la­tors have ac­cept­ed cap­ma­tinib, an or­phan and “break­through” MET in­hibitor, for pri­or­i­ty re­view. The hon­or tech­ni­cal­ly goes to No­var­tis, which li­censed world­wide de­vel­op­ment and com­mer­cial­iza­tion rights to the drug back in 2009.

But that didn’t stop In­cyte from brag­ging about it in a re­lease, re­mind­ing in­vestors that if every­thing goes well, it’s el­i­gi­ble for $500 mil­lion-plus in mile­stones as well as roy­al­ties up to 14% of glob­al sales.

Shav­ing four months off the re­view time­line — as­sum­ing there aren’t hic­cups — helps en­sure that No­var­tis can score an ap­proval with­in this year. The phar­ma gi­ant had des­ig­nat­ed cap­ma­tinib (for­mer­ly INC280) as one of four ma­jor launch­es of 2020, pre­dict­ing a block­buster fu­ture for a drug ini­tial­ly aimed at a sub­type of non-small cell lung can­cer.

NSCLC pa­tients who har­bor a MET ex­on-14 skip­ping mu­ta­tion cur­rent­ly have no ap­proved tar­get­ed ther­a­py. A No­var­tis-spon­sored Phase II tri­al showed that cap­ma­tinib in­duced an over­all re­sponse rate of 67.9% among treat­ment-naïve pa­tients (du­ra­tion of re­sponse 11.14 months) and 40.6% among pre­vi­ous­ly treat­ed ones (DOR 9.72 months).

Those 97 pa­tients had EGFR wild­type, ALK-neg­a­tive tu­mors, and took 400 mg cap­ma­tinib tablets twice a day.

“ME­Tex14 mu­ta­tions oc­cur in 3-4% of new­ly di­ag­nosed ad­vanced NSCLC cas­es and is a rec­og­nized onco­genic dri­ver,” No­var­tis not­ed in a state­ment.

Mer­ck KGaA and Pfiz­er al­so an­gling for this un­tapped niche; both have been grant­ed break­through ther­a­py des­ig­na­tions, though theirs on­ly cov­er sec­ond-line ther­a­py fol­low­ing plat­inum-based chemo. While tepo­tinib from the Ger­man drug­mak­er was en­gi­neered as a se­lec­tive MET in­hibitor, the drug Pfiz­er has put for­ward is Xalko­ri, orig­i­nal­ly tar­get­ed at ALK and ROS1 mu­ta­tions.

Mean­while, in Chi­na, Chi-Med is al­so test­ing As­traZeneca’s MET in­hibitor, savoli­tinib, in a Phase II reg­is­tra­tional tri­al among pa­tients who have pro­gressed fol­low­ing pri­or sys­temic ther­a­py or are un­able to re­ceive chemo.

A com­pan­ion di­ag­nos­tic will like­ly be key to the adop­tion of any of these treat­ments. No­var­tis has teamed up with Foun­da­tion Med­i­cine — now a Roche sub­sidiary — to in­clude tu­mor tis­sue and liq­uid biop­sy di­ag­nos­tics on its flag­ship prod­ucts.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.