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.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.