Be­set by hun­dreds of opi­oid law­suits and hun­dreds of mil­lions in pay­ments owed un­der a re­cent fed­er­al rul­ing on one of their best-sell­ing drugs, Mallinck­rodt, the 150-year-old Irish drug­mak­er, has filed for Chap­ter 11 bank­rupt­cy.

Mallinck­rodt, a com­pa­ny that once sold more opi­oids in the US than any oth­er, be­comes the third ma­jor opi­oid pro­duc­er to file for bank­rupt­cy amid a sea of lit­i­ga­tion. Pur­due Phar­ma and In­sys Ther­a­peu­tics each filed for bank­rupt­cy last year.

Bank­rupt­cy has be­come a com­mon tac­tic for the com­pa­nies that prof­it­ed off the opi­oid epi­dem­ic and now face thou­sands of law­suits in part, crit­ics say, be­cause it can freeze lit­i­ga­tion and leave those lit­i­gants com­pet­ing for pay­outs with a com­pa­ny’s cred­i­tors. Mallinck­rodt said they plan to con­tin­ue with a ten­ta­tive set­tle­ment they reached ear­li­er this year.

Ru­mors of a Mallinck­rodt bank­rupt­cy have swirled for months. In Feb­ru­ary, the drug­mak­er agreed to a set­tle­ment with most of its lit­i­gants, in­clud­ing 47 states and US ter­ri­to­ries, that would see it pay $1.6 bil­lion to re­solve claims over its role in the opi­oid cri­sis.

In March, though, a fed­er­al court found Mallinck­rodt li­able for over $600 mil­lion in un­paid Med­ic­aid re­bates for its top-sell­ing mul­ti­ple scle­ro­sis drug Ac­thar Gel. In sub­se­quent court fil­ings and state­ments, the com­pa­ny said that the rul­ing jeop­ar­dized their abil­i­ty to pay off the opi­oid set­tle­ment, warn­ing in June they may “have no op­tion but to take dras­tic and painful mea­sures, up to and in­clud­ing the prospect of bank­rupt­cy.”

The com­pa­ny said to­day they’ve agreed to pay $260 mil­lion to set­tle Med­ic­aid claims and that they plan to pro­ceed with the $1.6 bil­lion opi­oid set­tle­ment, pay­ing out the lat­ter over 8 years, be­gin­ning with a $450 mil­lion pay­out when they emerge from bank­rupt­cy. The par­ties in the law­suit will al­so re­ceive shares worth about 20% of the com­pa­ny.

Mallinck­rodt list­ed be­tween $1 and $10 bil­lion in as­sets and li­a­bil­i­ties. They are hop­ing to pare down their debt by $1.3 bil­lion.

Un­like Pur­due, which is at­tempt­ing to re-emerge post-bank­rupt­cy as a pro­duc­er of an­ti-ad­dic­tion drugs, Mallinck­rodt in­tends to con­tin­ue de­vel­op­ing new com­pounds dur­ing and post-bank­rupt­cy. Its pipeline, how­ev­er, has been less than ro­bust in re­cent years. Their lead ex­per­i­men­tal com­pound, the rare kid­ney dis­ease drug Ter­li­pressin, was re­ject­ed by the FDA for a sec­ond time last month, af­ter an in­ter­nal re­view spot­light­ed safe­ty con­cerns and lin­ger­ing ques­tions over whether the drug was ef­fec­tive.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.