No­var­tis’ gener­ics arm San­doz said it has sub­mit­ted ap­pli­ca­tions for a mul­ti­ple scle­ro­sis and Crohn’s dis­ease biosim­i­lar.

The drug is a biosim­i­lar for Bio­gen’s Tysabri, known gener­i­cal­ly as na­tal­izum­ab. Ac­cord­ing to San­doz, in pa­tients with re­laps­ing-re­mit­ting MS, the biosim­i­lar matched Tysabri in both ef­fi­ca­cy and safe­ty. Its BLA for the biosim­i­lar has been ac­cept­ed by both US and EU au­thor­i­ties, San­doz said.

Tysabri was first ap­proved in 2004 for re­laps­ing forms of MS, and then ap­proved in 2008 for Crohn’s dis­ease. The drug is one of the ear­li­est in Bio­gen’s suite of MS ther­a­pies. Bio­gen is al­so fac­ing slid­ing sales for its back­bone MS drug Tec­fidera due to gener­ic com­pe­ti­tion, and in March was de­nied a re­hear­ing af­ter it lost its ap­peal for a Tec­fidera patent late last year.

In 2021, Bio­gen made just over $2 bil­lion on Tysabri sales, and $1.95 bil­lion in Tec­fidera sales, down from $3.8 bil­lion the year be­fore.

San­doz said it would be pur­su­ing all in­di­ca­tions in which Tysabri is ap­proved for its biosim­i­lar ver­sion, which was de­vel­oped by Pol­phar­ma Bi­o­log­ics.

In oth­er news, ear­li­er this month, a San­doz spokesper­son ad­dressed ru­mors that No­var­tis might spin off its gener­ic arm, telling End­points News that No­var­tis would make that de­ci­sion by the end of the year. — Lei Lei Wu

Two weeks af­ter fail­ing late-stage mus­cle in­jury tri­al, Pluris­tem re­brands as Pluri 

A wind­ing road of at­tempt­ing to re­gen­er­ate mus­cles af­ter hip frac­ture surgery, treat res­pi­ra­to­ry is­sues in pa­tients with Covid-19, and ad­dress a host of oth­er dis­eases and hema­to­log­i­cal de­fi­cien­cies has led an Is­rael-based biotech to switch up its name.

The re­brand­ing comes at Pluris­tem Ther­a­peu­tics, or Pluri, as it now wants to be known by. Two weeks ago, the com­pa­ny’s in­tra­mus­cu­lar ad­min­is­tra­tion of al­lo­gene­ic PLX-PAD cells failed to meet the pri­ma­ry end­point in a Phase III study at­tempt­ing to treat mus­cle in­jury af­ter hip frac­ture op­er­a­tion.

The biotech al­so flamed out in the lung con­di­tion acute res­pi­ra­to­ry dis­tress syn­drome, in as­so­ci­a­tion with Covid-19 pa­tients, in a mid-stage study late last year.

Go­ing for­ward, Pluri will trade on Nas­daq as $PLUR in­stead of $PSTI. The rea­son­ing? Pluri is po­si­tion­ing ther­a­peu­tics as just a por­tion of its plans — food-tech, agri-tech, bi­o­log­ics and oth­er med­ical re­search all fall un­der the com­pa­ny’s am­bi­tions. That’s in­clu­sive of part­ner­ships aimed at “glob­al well­be­ing and sus­tain­abil­i­ty,” in­clud­ing team­ing up with Is­rael food pro­duc­er Tnu­va Group in Feb­ru­ary to cre­ate cell-based prod­ucts in the field of cul­tured meat via a new com­pa­ny 84% owned by Pluris­tem.

“Like our new lo­go’s dot-con­nect­ing arch sug­gests, it is time for Pluri to move from this sin­gle point to next gen­er­a­tion prod­ucts across a range of fields,” CEO Yaky Yanay said in a state­ment. — Kyle LaHu­cik

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.

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.