Up­dat­ed: FDA calls for non­in­fe­ri­or­i­ty tri­als for an­tibac­te­ri­als, thanks to new drugs for re­sis­tant in­fec­tions

The FDA on Mon­day said it up­dat­ed its rec­om­men­da­tions for the clin­i­cal de­vel­op­ment of new an­tibac­te­r­i­al drugs, and thanks to a new clutch of drugs, spon­sors will have to con­duct non­in­fe­ri­or­i­ty tri­als that in­clude sub­jects with in­fec­tions caused by cer­tain drug-re­sis­tant or­gan­isms be­cause an ef­fec­tive ac­tive con­trol can be pro­vid­ed.

The guid­ance, which has since been re­leased, builds on a 2017 doc­u­ment and spec­i­fies what non­in­fe­ri­or­i­ty tri­al de­signs may be used “with a wider NI mar­gin,” in­clud­ing cas­es in which the tri­al pop­u­la­tion is en­riched for sub­jects with in­fec­tions caused by cer­tain drug-re­sis­tant or­gan­isms, FDA said.

The fed­er­al agency said in the guid­ance that the ac­tive com­para­tor used to show non­in­fe­ri­or­i­ty should be ef­fec­tive for the pop­u­la­tion en­rolled in the clin­i­cal tri­al, fur­ther stat­ing that the pri­ma­ry analy­sis should ex­clude sub­jects with base­line pathogens re­sis­tant to the con­trol.

“A ran­dom­ized tri­al de­sign is need­ed be­cause both com­par­a­tive safe­ty and ef­fi­ca­cy eval­u­a­tions can be per­formed. The ran­dom­ized clin­i­cal tri­al da­ta can be sup­port­ed by con­fir­ma­to­ry ev­i­dence from non­clin­i­cal stud­ies demon­strat­ing the ac­tiv­i­ty of the in­ves­ti­ga­tion­al drug against re­sis­tant phe­no­types,” the guid­ance went on to say.

When draft­ing the guid­ance, an FDA spokesper­son told End­points News that FDA was con­sid­er­ing re­cent­ly ap­proved be­ta-lac­tam/be­ta-lac­ta­mase in­hibitor com­bi­na­tions that showed ex­tend­ed ac­tiv­i­ty against drug-re­sis­tant or­gan­isms, such as those that pro­duce car­bapen­e­mases.

Since 2017, about 12 new drugs won ap­proval in this space, show­ing ac­tiv­i­ty against treat­ment-re­sis­tant or­gan­isms — in­clud­ing drugs like TB Al­liance’s pre­tomanid, which got the thumbs up from the fed­er­al reg­u­la­tor for treat­ment-re­sis­tant tu­ber­cu­lo­sis ap­proved back in 2019. Oth­ers in­clude Achao­gen’s pla­zomicin, now known as Zem­dri, for com­pli­cat­ed uri­nary tract in­fec­tions in 2018 and No­var­tis spin­off Nabri­va’s lefa­mulin for pneu­mo­nia.

Yet as NIH re­searchers added in an ar­ti­cle they wrote in late 2019, that num­ber of drugs is not enough for the space.

The 2017-era guid­ance orig­i­nal­ly fo­cused on flex­i­bil­i­ty, with the agency say­ing that “it is ap­pro­pri­ate to ex­er­cise the broad­est flex­i­bil­i­ty in ap­ply­ing the statu­to­ry stan­dards, while pre­serv­ing ap­pro­pri­ate guar­an­tees for safe­ty and ef­fec­tive­ness.” It added that it rec­og­nized that physi­cians and pa­tients are “gen­er­al­ly will­ing to ac­cept greater risks or side ef­fects from drugs that treat life-threat­en­ing and se­vere­ly-de­bil­i­tat­ing ill­ness­es, than they would ac­cept from drugs that treat less se­ri­ous ill­ness­es.”

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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