In an­oth­er set­back for the be­lea­guered an­tibi­otics field, Nabri­va Ther­a­peu­tics says the FDA re­ject­ed its fos­fomycin for com­pli­cat­ed uri­nary tract in­fec­tions.

Ted Schroed­er

Im­por­tant­ly, the biotech says, reg­u­la­tors are not ask­ing for any new clin­i­cal or safe­ty da­ta. The com­plete re­sponse let­ter cen­ters around “is­sues re­lat­ed to fa­cil­i­ty in­spec­tions and man­u­fac­tur­ing de­fi­cien­cies at one of Nabri­va’s con­tract man­u­fac­tur­ers,” ac­cord­ing to a brief state­ment.

Over the next few weeks Nabri­va plans to re­quest a “Type A” meet­ing to dis­cuss the FDA’s find­ings. Shares $NR­BV are down 24% pre-mar­ket.

Across the in­dus­try, an­tibi­otics de­vel­op­ers and back­ers are suf­fer­ing from a new low in morale af­ter Achao­gen filed for bank­rupt­cy de­spite notch­ing an FDA ap­proval of its cU­TI drug, due to dis­ap­point­ing sales. And that fol­lows rounds of lay­offs at both Achao­gen and oth­er an­tibi­otics com­pa­nies like Melin­ta, with Big Phar­ma large­ly out of the pic­ture al­to­geth­er.

No­body would de­ny the ur­gent need for an­tibi­otics — just two days ago the UN is­sued an­oth­er re­port warn­ing of a “silent tsuna­mi” of an­timi­cro­bial re­sis­tance that threat­ens to kill 10 mil­lion peo­ple an­nu­al­ly by 2050 — but it’s in­creas­ing­ly hard to make a case for the R&D in­vest­ment when the prod­ucts are too niche to turn a prof­it in a world dom­i­nat­ed by gener­ics.

Nabri­va’s Con­tepo (IV fos­fomycin) is an old drug that’s been used out­side the US for over 45 years. Ac­cord­ing to the com­pa­ny, it can treat a num­ber of Gram-neg­a­tive and Gram-pos­i­tive bac­te­ria in­fec­tions, ac­tive against many com­mon mul­ti-drug re­sis­tant strains.

It bagged the drug via an ac­qui­si­tion of Za­vante, whose CEO Ted Schroed­er then took the helm of the new en­ti­ty. Nabri­va’s in-house lead pro­gram for com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia, lefa­mulin, is al­so un­der re­view with a PDU­FA date in Au­gust.

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

Ocular Therapeutix $OCUL has had its ups and downs in the 7 years since it went public. Friday was one of those down days.

The Bedford, MA-based biotech reported that its lead experimental eye drug, OTX-CSI (cyclosporine intracanalicular insert), failed a Phase II trial for dry eye disease. And the stock experienced one of its periodic meltdowns, dropping more than 30% ahead of the bell.

The therapy flat failed the primary endpoint: increased tear production at 12 weeks as measured by the Schirmer’s Test compared to the vehicle control group. And while investigators called out an improvement from baseline in “signs of dry eye disease as measured by total corneal fluorescein staining (CFS) and symptoms of dry eye disease as measured by the visual analogue scale (VAS) eye dryness in subjects treated with the OTX-CSI insert,” it wasn’t statistically significant.

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.