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.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.