→ Paratek Phar­ma­ceu­ti­cals‘ $PRTK Nuzyra (omada­cy­cline) has met all pri­ma­ry and sec­ondary clin­i­cal study end­points in their OA­SIS-2 Phase III clin­i­cal tri­al, ac­cord­ing to re­sults pub­lished in The Lancet In­fec­tious Dis­eases. In the study, in­volv­ing 735 adults with AB­SS­SI, Nuzyra was shown to be as ef­fec­tive as Pfiz­er‘s $PFE twice-dai­ly oral-on­ly Zyvox (line­zol­id). Nuzyra is cur­rent­ly avail­able in the US as a once-dai­ly oral and in­tra­venous an­tibi­ot­ic for the treat­ment of adults with com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia and AB­SS­SI. The drug is al­so be­ing stud­ied for the treat­ment of uri­nary tract in­fec­tions.

→ Wrap­ping a week of big opi­oid law­suit news, Al­ler­gan $AGN dis­closed that it’s set­tled with two Ohio coun­ties, avoid­ing a mul­ti-de­fen­dant tri­al sched­uled for Oc­to­ber. The drug­mak­er — which con­tends that it has not ac­tive­ly mar­ket­ed or pro­mot­ed any opi­oid prod­ucts since 2013 and that it does not have li­a­bil­i­ty for gener­ic claims — said it’s seek­ing in­dem­ni­fi­ca­tion from oth­er par­ties in the fed­er­al lit­i­ga­tion. Per the set­tle­ment, Al­ler­gan is pay­ing $1.9 mil­lion to Sum­mit Coun­ty and $3.1 mil­lion to Cuya­hoga Coun­ty.

→ On the heels of a fast track des­ig­na­tion, Akari Ther­a­peu­tics has added or­phan sta­tus to its lead drug no­ma­co­pan’s cre­den­tials. The C5 in­hibitor is be­ing po­si­tioned as a treat­ment for hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy in pe­di­atric pa­tients. The biotech plans to com­mence a piv­otal tri­al in the fourth quar­ter this year, said COO Clive Richard­son, who was in­stalled as in­ter­im CEO more than a year ago af­ter David Horn was oust­ed amid a scan­dal.

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

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.

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.