In case you didn’t get the memo, Gilead is bet­ting that a cock­tail ap­proach will win them a cov­et­ed place in the NASH show­down.

A day af­ter draw­ing at­ten­tion to pos­i­tive proof-of-con­cept da­ta around its cilofex­or/fir­so­co­stat ther­a­py, the Big Biotech says it’s kick­ing off an­oth­er clin­i­cal tri­al in col­lab­o­ra­tion with No­vo Nordisk in which semaglu­tide will be added to form a three-drug reg­i­men.

A block­buster fa­vorite among up-and-com­ing di­a­betes drugs, semaglu­tide is a GLP-1 ana­logue that not on­ly stim­u­lates se­cre­tion of in­sulin but al­so is thought to im­prove glu­cose me­tab­o­lism in the liv­er and in­crease fat­ty acid ox­i­da­tion. Giv­en that more than 40% of NASH pa­tients have di­a­betes and more than 80% of them are al­so liv­ing with obe­si­ty (No­vo Nordisk’s num­bers) — an­oth­er tar­get in­di­ca­tion for semaglu­tide — the Dan­ish drug­mak­er has called its in­ter­est in the dis­ease a “nat­ur­al ex­pan­sion.”

For Gilead, this will be an op­por­tu­ni­ty to for­ti­fy a grow­ing NASH port­fo­lio as well as flex its sci­en­tif­ic mus­cles. The part­ner­ship al­so cov­ers a po­ten­tial col­lab­o­ra­tion on pre­clin­i­cal re­search to bet­ter un­der­stand an ail­ment of­ten dubbed a silent dis­ease.

With car­diopul­monary sales wan­ing — caused by loom­ing gener­ic en­try and il­lus­trat­ed by a round of lay­offs an­nounced this week — the hep C op­er­a­tions shrink­ing, HIV un­der as­sault and the bold new CAR-T ven­ture slow to im­press, Gilead is pressed to find a new area in which it can es­tab­lish as for­mi­da­ble a pres­ence as it had in the an­tivi­ral realm.

It took a hit when selon­sert­ib flopped in a close­ly-watched Phase III, out­per­formed by the place­bo at the low dose, dash­ing hopes for a vault to the lead po­si­tion as a flock of small play­ers take turns to present their own late-stage re­sults.

As ri­vals — in­clud­ing In­ter­cept, Gen­fit, Madri­gal and NGM Bio, which is part­nered with Mer­ck — crowd in, Gilead has been pick­ing up ear­ly-stage as­sets in pur­suit of a sus­tain­ing fran­chise. In fact, cilofex­or came from the buy­out of Phenex Phar­ma and you might re­mem­ber fir­so­co­stat as GS-0976, which Gilead paid Nim­bus $600 mil­lion for.

The com­pa­ny al­so hasn’t giv­en up on selon­sert­ib, which is be­ing test­ed in a triple com­bo with cilofex­or and fir­so­co­stat.

Im­age: Er­ic Ris­berg AP

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.