Eu­gene Sun, CEO, Melin­ta

It’s tak­en 17 years and a long chain of CEOs, but pri­vate­ly held Melin­ta Ther­a­peu­tics has nabbed an FDA ap­proval for its an­tibi­ot­ic de­lafloxacin, which can now be sold as Baxdela.

Melin­ta an­nounced a lit­tle more than a year ago that the an­tibi­ot­ic had proven non-in­fe­ri­or to van­comycin for acute bac­te­r­i­al skin and skin struc­ture in­fec­tions (AB­SS­SI). The last switch up in the ex­ec­u­tive suite at Melin­ta, once called Rib-X, was when Mary Szela— now CEO of Nov­e­l­ion — was re­placed by R&D chief Eu­gene Sun in 2015.

Baxdela is a flu­o­ro­quinolone that ex­hibits ac­tiv­i­ty against both gram-pos­i­tive and gram-neg­a­tive pathogens, in­clud­ing MR­SA, in both oral and IV forms.

Melin­ta is one of a few late-stage de­vel­op­ers in this space, look­ing to ad­dress the grow­ing de­mand for new an­tibi­otics in a world of grow­ing drug re­sis­tance. Za­vante tout­ed its own win in April, prep­ping an FDA ap­pli­ca­tion. Paratek hit a few days ahead of that biotech. But Cem­pra has had a ma­jor set­back to deal with.

The field has its at­trac­tions, but it’s not easy, which ex­plains an ab­sence of many large phar­ma play­ers on the R&D side. There are a num­ber of cheap, gener­ic an­tibi­otics avail­able for front­line use. And any new an­tibi­ot­ic is go­ing to face an up­hill bat­tle gain­ing trac­tion in this mar­ket.

“The ap­prox­i­mate­ly 3 mil­lion pa­tients hos­pi­tal­ized each year in the U.S. with AB­SS­SI of­ten present treat­ment chal­lenges ow­ing to their un­der­ly­ing med­ical con­di­tions, mak­ing op­ti­mal an­tibi­ot­ic se­lec­tion dif­fi­cult. Baxdela pro­vides a treat­ment op­tion for adult pa­tients with AB­SS­SI based on its cov­er­age spec­trum, IV and oral dos­ing flex­i­bil­i­ty, ef­fi­ca­cy and safe­ty pro­file,” said Sun in a pre­pared state­ment. “The ap­proval of Baxdela demon­strates FDA’s com­mit­ment to mak­ing new and ef­fec­tive an­tibi­otics avail­able to ad­dress un­met needs for hos­pi­tal­ized AB­SS­SI pa­tients.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

AstraZeneca’s big gamble on Daiichi Sankyo’s antibody-drug conjugate Enhertu has already paid off with a big approval in breast cancer more than a year ago. But the partners have big plans for their blockbuster in the making, and a new nod in gastric cancer will raise their spirits even higher.

The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.

Close to 70 years after Oxford scientists purified penicillin and confirmed its effect as an antibacterial drug, the university is establishing a new research institute at the forefront of combating antimicrobial resistance.

The Ineos Oxford Institute for AMR Research will initially be powered by a $136 million (£100 million) donation from Ineos, the UK-based chemicals giant founded by billionaire Jim Ratcliffe, that also plays a hand in manufacturing medical and pharma products.