On the same day that Glax­o­SmithK­line sought to as­sure in­vestors that the com­pa­ny’s new R&D team would de­liv­er im­por­tant drugs in the fu­ture, its re­searchers work­ing on Nu­cala (mepolizum­ab) were slapped down in their at­tempt to gain an added OK for COPD.

A pan­el of out­side ex­perts vot­ed 16 to 3 against a mar­ket­ing ap­proval. That isn’t bind­ing, but af­ter the in­ter­nal re­view­ers at the FDA of­fered a scathing re­view of their da­ta, it’s all but a done deal now — bar­ring some un­ex­pect­ed last minute in­ter­ven­tion in its fa­vor.

AD­COMM VOTE: Is the ben­e­fit-risk pro­file ad­e­quate to sup­port ap­proval of #mepolizum­ab as add-on treat­ment to in­haled cor­ti­cos­teroid-based main­te­nance treat­ment for the re­duc­tion of ex­ac­er­ba­tions in pa­tients with #COPD guid­ed by blood eosinophil counts? $GSK
3-Yes
16-No
0-Ab­stain

— SAC Track­er (@FDAad­comm) Ju­ly 25, 2018

The FDA was clear­ly unim­pressed with GSK’s pack­age.

GSK’s drug failed one late-stage test while scor­ing a suc­cess in the oth­er. With on­ly two Phase III stud­ies in this in­di­ca­tion, that left the pan­el to con­sid­er an ap­proval with­out sup­port­ing da­ta from two well-con­trolled stud­ies — the agency gold stan­dard.

There was no dose re­sponse they could find in the two dosage arms, which didn’t help.

The FDA added:

Some key sec­ondary end­points, such as time to first mod­er­ate-to-se­vere COPD ex­ac­er­ba­tion showed nu­mer­i­cal trends fa­vor­ing mepolizum­ab. How­ev­er, there were no con­sis­tent and clin­i­cal­ly mean­ing­ful dif­fer­ences in se­vere COPD ex­ac­er­ba­tion rate, FEV1, or SGRQ be­tween mepolizum­ab 100 mg and place­bo.

GSK’s tri­al de­sign al­so spurred ques­tions, with no base­line col­lec­tion of asth­ma his­to­ry — which could have in­flu­enced the out­come of the study. How will GSK prop­er­ly de­fine the pa­tient pop­u­la­tion for this drug?

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

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.

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.