In the 10th ap­proval since its 2013 launch, J&J’s can­cer drug Im­bru­vi­ca has se­cured the FDA nod in com­bi­na­tion with Roche’s obin­u­tuzum­ab in adults with the most com­mon form of leukemia — mark­ing the first non-chemother­a­py reg­i­men for treat­ment-naïve pa­tients with chron­ic lym­pho­cyt­ic leukemia/small lym­pho­cyt­ic lym­phoma (CLL/SLL).

The ap­proval ex­pands the use of Im­bru­vi­ca — which is al­so sold by Ab­b­Vie — in front­line CLL/SLL be­yond its use as a monother­a­py. The drug it­self gen­er­at­ed sales of about $2.6 bil­lion last year. The block­buster treat­ment has seen steady growth in mar­ket share, lead­ing the Unit­ed States in first and sec­ond line CLL as well as sec­ond-line man­tle cell lym­phoma (MCL), and is the to­tal pa­tient share leader in Walden­strom macroglob­u­line­mia (WM) — a type of non-Hodgkin lym­phoma — ac­cord­ing to Cred­it Su­isse.

The ap­proval of Im­bru­vi­ca in com­bi­na­tion with CD20 an­ti­body obin­u­tuzum­ab was based on the Phase III iL­LU­MI­NATE study. The 212-pa­tient open-la­bel tri­al test­ed Im­briv­i­ca+obin­u­tuzum­ab ver­sus obin­u­tuzum­ab+chlo­ram­bu­cil (a chemother­a­py treat­ment). At a me­di­an fol­low-up of about 31 months, the Im­bru­vi­ca reg­i­men helped pa­tients live longer with­out their dis­ease pro­gress­ing com­pared to the chemother­a­py reg­i­men (19 months), with 77% re­duc­tion in risk of pro­gres­sion or death, J&J said.

CLL is a com­mon type of can­cer that can de­vel­op from cells in the bone mar­row that lat­er ma­ture in­to cer­tain white blood cells, and ac­counts for about one-quar­ter of the new cas­es of leukemia, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety, which es­ti­mates about 20,720 new CLL cas­es will oc­cur in 2019. SLL is a slow-grow­ing lym­phoma bi­o­log­i­cal­ly sim­i­lar to CLL in which too many im­ma­ture white blood cells cause lymph nodes to be­come larg­er than nor­mal.

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

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.