→ An­tibac­te­r­i­al R&D ac­cel­er­a­tor CARB-X has grant­ed Achao­gen $AKAO an award worth up to $12 mil­lion to fu­el its ear­ly-stage pro­grams in for mul­ti-drug re­sis­tant gram-neg­a­tive in­fec­tions. With an ini­tial pay­ment of $2.4 mil­lion, the South San Fran­cis­co biotech will fo­cus on de­vel­op­ing next-gen ver­sions of a com­mon class of an­tibi­otics called amino­gly­co­side, aim­ing to over­come cur­rent re­sis­tance mech­a­nisms. The part­ners are par­tic­u­lar­ly keen on the prospect of treat­ing En­ter­obac­te­ri­aceae, P. aerug­i­nosa and A. bau­man­nii, all “pri­or­i­ty 1 crit­i­cal pathogens” as rec­og­nized by the WHO. “The projects in the Pow­ered by CARB-X port­fo­lio are in the ear­ly stages of re­search, but if suc­cess­ful, these in­no­v­a­tive projects hold great po­ten­tial to treat se­ri­ous in­fec­tions and fight against the rise of drug-re­sis­tant bac­te­ria,” said Kevin Out­ter­son, ex­ec­u­tive di­rec­tor of CARB-X (for­mer­ly known as the Com­bat­ing An­tibi­ot­ic Re­sis­tant Bac­te­ria Bio­phar­ma­ceu­ti­cal Ac­cel­er­a­tor).

→ Gener­ics and spe­cial­ty phar­ma­ceu­ti­cals com­pa­ny En­do In­ter­na­tion­al Plc plans to ac­quire New Jer­sey’s Som­er­set Ther­a­peu­tics for $190 mil­lion. The ac­qui­si­tion will bring Som­er­set’s ster­ile in­jectable and oph­thalmic drugs, but al­so the busi­ness of its In­dia-based af­fil­i­ate Win­tac, which serves as Som­er­set’s con­tract de­vel­op­er and man­u­fac­tur­er. Som­er­set’s port­fo­lio in­cludes 8 com­mer­cial prod­ucts as well as a pipeline of more than 40 prod­ucts, over 25 of which have been sub­mit­ted for ap­proval to the FDA, the com­pa­ny said. “We be­lieve Som­er­set Ther­a­peu­tics is an ide­al strate­gic fit for En­do as it ex­pands our port­fo­lio of ster­ile in­jectable and oph­thalmic prod­ucts,” said Paul Cam­pan­el­li, En­do’s pres­i­dent and CEO, in a state­ment. “Ad­di­tion­al­ly, Win­tac’s strong ster­ile R&D and high-qual­i­ty man­u­fac­tur­ing ca­pa­bil­i­ties have con­tributed great­ly to Som­er­set Ther­a­peu­tics’ steady rev­enue growth. We see sig­nif­i­cant op­por­tu­ni­ties to lever­age our ex­ist­ing sales and mar­ket­ing ca­pa­bil­i­ties as we seek to max­i­mize the val­ue of the cur­rent and ex­pect­ed fu­ture Som­er­set Ther­a­peu­tics’ prod­ucts.”

With con­tri­bu­tion by Brit­tany Meil­ing.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.