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

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.