→ 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.

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.