The FDA this morn­ing an­nounced two up­com­ing ad­vi­so­ry com­mit­tee meet­ings in April and May — with the goal of re­view­ing two drugs with a lot of his­to­ry that have gone through mul­ti­ple set­backs.

Ac­cord­ing to no­tices pub­lished in the Fed­er­al Reg­is­ter, the FDA is con­ven­ing its An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee on April 17 to dis­cuss En­ta­sis Ther­a­peu­tics’ NDA for sul­bac­tam-dur­lobac­tam for the treat­ment of Acine­to­bac­ter in­fec­tions.

The biotech, spun out of As­traZeneca’s for­mer an­tibi­otics di­vi­sion in 2015, is gun­ning for the an­tibi­ot­ic to win ap­proval to treat in­fec­tions of Acine­to­bac­ter bau­man­nii-cal­coaceti­cus com­plex, in­clud­ing mul­tidrug-re­sis­tant and car­bapen­em-re­sis­tant strains. En­ta­sis’ NDA was ac­cept­ed back in No­vem­ber and grant­ed pri­or­i­ty re­view, with a PDU­FA date of May 29.

The drug is part of a deal with Zai Lab, a Shang­hai-based biotech with an ex­clu­sive de­vel­op­ment and com­mer­cial­iza­tion li­cense in more than a dozen coun­tries in the Asia-Pa­cif­ic re­gion, in­clud­ing Chi­na, Ko­rea, Japan, the Philip­pines and New Zealand.

The biotech was once pub­lic on Nas­daq be­fore be­ing picked up last year by backer In­no­vi­va, which bought out all the biotech’s shares at $2.20 apiece — tak­ing the com­pa­ny pri­vate back in May.

In­no­vi­va al­ready owned 60% of the com­pa­ny at the time of the deal.

The oth­er ad­comm, sched­uled for May 19, is gath­er­ing the FDA’s Gas­troin­testi­nal Drugs Ad­vi­so­ry Com­mit­tee to re­view In­ter­cept Phar­ma­ceu­ti­cals’ obeti­cholic acid to treat non­al­co­holic steato­hep­ati­tis (NASH).

In­ter­cept has had a rough his­to­ry push­ing this liv­er drug to mar­ket. In­ter­cept’s NDA, which was giv­en an ac­tion date of June 22, is the sec­ond at­tempt bring­ing this drug past reg­u­la­tors.

The FDA pre­vi­ous­ly re­ject­ed obeti­cholic acid in 2020 af­ter the agency be­came un­cer­tain — per In­ter­cept at the time — if the sur­ro­gate end­point, re­duc­tion in liv­er fi­bro­sis, from a Phase III tri­al would trans­late in­to clin­i­cal ben­e­fit.

The drug de­vel­op­er, af­ter re­port­ing a Phase III fail back in Sep­tem­ber 2022, high­light­ed in­ter­im analy­ses from a piv­otal Phase III study, in­clud­ing one where pa­tients on 25 mg of the drug saw “dou­ble the re­sponse rate of place­bo in re­duc­tion in liv­er fi­bro­sis stage with­out wors­en­ing of any of the three his­to­log­ic com­po­nents of NASH,” the biotech said back in Jan­u­ary, call­ing the end­point in line with FDA guid­ance.

In­ter­cept CEO Jer­ry Dur­so said in a state­ment Fri­day, “We look for­ward to the op­por­tu­ni­ty to dis­cuss with the Ad­vi­so­ry Com­mit­tee our clin­i­cal tri­al da­ta.”

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.