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.

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.