Pur­due Phar­ma, the pro­duc­er of the pre­scrip­tion painkiller Oxy­Con­tin, ad­mit­ted Tues­day that, yes, it did con­tribute to Amer­i­ca’s opi­oid epi­dem­ic.

The drug­mak­er for­mal­ly plead­ed guilty to three crim­i­nal charges, the AP re­port­ed, in­clud­ing get­ting in the way of the DEA’s ef­forts to com­bat the cri­sis, fail­ing to pre­vent the painkillers from end­ing up on the black mar­ket and en­cour­ag­ing doc­tors to write more painkiller pre­scrip­tions through two meth­ods: pay­ing them in a speak­ers pro­gram and di­rect­ing a med­ical records com­pa­ny to send them cer­tain pa­tient in­for­ma­tion. Pur­due’s plea deal calls for $8.3 bil­lion in crim­i­nal fines and penal­ties, but the com­pa­ny is on­ly li­able for a frac­tion of that to­tal — $225 mil­lion.

Re­ports that the deal had been close were pre­vi­ous­ly float­ed twice in Oc­to­ber, and the pleas are a part of the set­tle­ment deal an­nounced by the Jus­tice De­part­ment last month.

Mem­bers of the bil­lion­aire Sack­ler fam­i­ly did not per­son­al­ly plead guilty to any crimes, and they have agreed to pay $225 mil­lion of their own mon­ey to set­tle civ­il claims. The plea deal signed Tues­day leaves open the pos­si­bil­i­ty they may be charged in the fu­ture, how­ev­er.

Pur­due has been caught up in opi­oid leg­is­la­tion for more than a decade and a half, with pros­e­cu­tors in Pres­i­dent George W. Bush’s ad­min­is­tra­tion rec­om­mend­ing felony charges for the com­pa­ny and prison time for top ex­ec­u­tives af­ter a four-year in­ves­ti­ga­tion con­clud­ed in 2006. But the Jus­tice De­part­ment set­tled that case the next year — Pur­due plead­ed guilty to “mis­brand­ing” Oxy­Con­tin and agreed to $600 mil­lion in fines, while the ex­ecs al­so plead­ed guilty and paid $34.5 mil­lion in penal­ties.

The cen­tral claim of that case dealt with Oxy­Con­tin’s sup­posed long-act­ing for­mu­la. Pur­due claimed that be­cause of its time-re­lease for­mu­la­tion, Oxy­Con­tin had a low­er po­ten­tial for abuse than oth­er opi­oid painkillers like Per­co­cet or Vi­codin while ag­gres­sive­ly mar­ket­ing the drug to doc­tors and pa­tients.

Lit­i­ga­tion mount­ed over the last sev­er­al years, and Pur­due ul­ti­mate­ly filed for Chap­ter 11 in 2019 as part of a deal be­ing ne­go­ti­at­ed at the time that would have cov­ered about $10 bil­lion in pay­ments. In the bank­rupt­cy case, Pur­due has pro­posed trans­form­ing in­to a pub­lic ben­e­fit cor­po­ra­tion with its pro­ceeds go­ing to help ad­dress the opi­oid cri­sis, per the AP.

Tues­day’s deal is un­like­ly to sa­ti­ate the claims of crit­ics that say Pur­due should have faced harsh­er penal­ties and calls for charg­ing the Sack­ler fam­i­ly for prof­it­ing off Oxy­Con­tin sales.

Pur­due was the first of three ma­jor opi­oid drug­mak­ers to de­clare bank­rupt­cy, with In­sys and Mallinck­rodt fol­low­ing in their foot­steps. The com­pa­nies have faced fur­ther crit­i­cism for go­ing down this route, with op­po­nents say­ing the moves can freeze lit­i­ga­tion and leave those lit­i­gants com­pet­ing for pay­outs with a com­pa­ny’s cred­i­tors.

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries.

Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.