Bris­tol-My­ers Squibb $BMY has a fresh Phase III set­back to re­port to­day on its all-im­por­tant PD-1 drug Op­di­vo. The phar­ma gi­ant says that their drug com­bined with ra­di­a­tion failed to sig­nif­i­cant­ly im­prove the over­all sur­vival rate of glioblas­toma pa­tients com­pared to a con­trol group re­ceiv­ing chemo plus ra­di­a­tion.

As usu­al, re­searchers will hold back the da­ta for a fu­ture con­fer­ence, but Check­Mate-498 is an­oth­er write-off.

“GBM is a no­to­ri­ous­ly ag­gres­sive can­cer,” notes Bris­tol-My­ers on­col­o­gy R&D chief Fouad Namouni, who ex­pressed their dis­ap­point­ment with the fail­ure.

Fouad Namouni

Op­di­vo earned $1.8 bil­lion in Q1 alone for Bris­tol-My­ers Squibb, a 19% gain over the same pe­ri­od a year ago. That’s no small ac­com­plish­ment in bio­phar­ma, but it al­so marks a sec­ond place po­si­tion be­hind an in­creas­ing­ly dom­i­nant Mer­ck — $2.3 bil­lion in Q1, up 55% — which has had far more suc­cess­es to re­port from the R&D group.

It’s un­like­ly that any of the an­a­lysts had much up­side built in for glioblas­toma, the most com­mon brain can­cer which has proven to be in­cred­i­bly dif­fi­cult to slow down. So don’t look for any dra­mat­ic stock moves. On the oth­er hand, the phar­ma gi­ant has been plagued by set­backs in the clin­ic. 

The com­pa­ny had to yank its ap­pli­ca­tion us­ing a high tu­mor mu­ta­tion­al bur­den af­ter get­ting some neg­a­tive feed­back from the FDA. Their com­bo ap­proach us­ing Yer­voy failed in non-small cell lung can­cer, and that fol­lowed a fail­ure against the stan­dard of care for sec­ond-line small cell lung can­cer. A brain can­cer flop may have been pre­dictable, but it al­so rais­es ques­tions about their R&D strat­e­gy at a time Mer­ck has been ad­vanc­ing with its chemo com­bo ap­proach.

With some key read­outs due on front­line lung can­cer, Bris­tol-My­ers is in a make-or-break po­si­tion with Op­di­vo, with an­a­lysts like Wolfe’s Tim An­der­son won­der­ing if they’re head­ed for a peak in Op­di­vo sales in 2020, fol­lowed by a flat line as com­pe­ti­tion builds around the world. That al­ready may have dri­ven their $74 bil­lion Cel­gene ac­qui­si­tion, which will shift fo­cus to a slate of 6 late-stage drugs up for an ap­proval de­ci­sion.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.