Months af­ter the FDA sanc­tioned the ap­proval of Roche’s run­ner up check­point in­hibitor Tecen­triq in com­bi­na­tion with Cel­gene’s Abrax­ane for treat­ment naive pa­tients with triple neg­a­tive breast can­cer, Mer­ck’s keynote PD-1 Keytru­da has stum­bled in a late-stage tri­al as the sec­ond or third line of de­fense against the rare, ag­gres­sive form of can­cer.

Pa­tients in the 622-pa­tient tri­al were ei­ther giv­en the block­buster treat­ment or chemother­a­py. The main goal of the study — over­all sur­vival — was not met, Mer­ck said, adding that de­tails will be dis­closed at a lat­er date.

The US drug­mak­er will con­tin­ue to test Keytru­da monother­a­py and in com­bi­na­tion with chemother­a­py in ear­li­er stages of the dif­fi­cult-to-treat dis­ease.

About 10-20% of all breast can­cers are triple-neg­a­tive breast can­cers (TNBCs), which char­ac­ter­is­ti­cal­ly has a high re­cur­rence rate with­in the first five years af­ter di­ag­no­sis. In TNBC pa­tients, the growth of the can­cer is not fu­eled by the hor­mones es­tro­gen and prog­es­terone, or by the HER2 pro­tein, mak­ing it hard to treat.

Roche’s Tecen­triq com­bi­na­tion with Abrax­ane was the first-ever im­munother­a­py to get ap­proval in the first­line TNBC set­ting. The ap­proval was key for the Swiss drug­mak­er that is third-in-line — be­hind Bris­tol-My­ers Squibb and Mer­ck — for the check­point in­hibitor Iron throne. The large drug­mak­er must get ahead of its ri­vals in cru­cial can­cer ar­eas if it wants to hold on to its po­si­tion, as As­traZeneca carves out a niche for its PD-L1 check­point Imfinzi in a sub­set of non-small cell lung can­cer pa­tients.

About 70% of breast can­cers di­ag­nosed in peo­ple with an in­her­it­ed BR­CA mu­ta­tion, par­tic­u­lar­ly BR­CA1, are di­ag­nosed with TNBC. PARP in­hibitors such as As­traZeneca’s Lyn­parza and Pfiz­er’s Talzen­na are al­ready ap­proved for germline BR­CA-mu­tat­ed breast can­cer, and are be­ing in­ves­ti­gat­ed in com­bi­na­tion with check­point in­hibitors for TNBC.

Mean­while, an­ti­body drug con­ju­gates are an­oth­er po­ten­tial treat­ment op­tion for TNBC un­der in­ves­ti­ga­tion.

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.

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

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.