Roche’s Chugai unit and As­traZeneca’s Alex­ion have set­tled a years­long patent bat­tle over the lat­ter’s Ul­tomiris — a rare blood dis­or­der treat­ment de­signed to suc­ceed Alex­ion’s block­buster Soliris, ac­cord­ing to re­ports.

The set­tle­ment was filed un­der seal on Mon­day, Bloomberg Law and Law 360 re­port­ed, and the terms are cur­rent­ly un­known. Alex­ion de­clined to com­ment on the case, while Chugai wasn’t avail­able as of press time.

The trou­ble dates back to 2018 (be­fore Ul­tomiris was ap­proved) when Chugai filed a com­plaint against Alex­ion al­leg­ing that the com­pa­ny used its patent­ed an­ti­body re­cy­cling tech­nol­o­gy to cre­ate the drug. The tech­nol­o­gy, Chugai says, could be used to ex­tend the half-life of an an­ti­body in the blood, and “im­prove the func­tion of C5 in­hibit­ing an­ti­bod­ies, in­clud­ing those used to treat rare blood dis­eases like PNH and aHUS.”

Like its pre­de­ces­sor Soliris, Ul­tomiris is a C5 in­hibitor — but while Soliris is dosed every two weeks dur­ing the main­te­nance pe­ri­od, Ul­tomiris can be tak­en every eight weeks. It snagged its first ap­proval in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH), a rare but life-threat­en­ing blood dis­ease, in De­cem­ber 2018. Less than a year lat­er, it picked up a sec­ond ap­proval for atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS), a dis­ease that can cause pro­gres­sive in­jury to vi­tal or­gans via dam­age to the walls of blood ves­sels and blood clots.

Soliris and Ul­tomiris were key el­e­ments in As­traZeneca’s $39 bil­lion Alex­ion buy­out last sum­mer. The lat­ter raked in $688 mil­lion in 2021, ac­cord­ing to re­cent­ly re­leased Q4 re­sults.

In its 2018 com­plaint, Chugai ar­gued that Alex­ion knew of the al­leged patent in­fringe­ment be­cause the com­pa­ny made “mul­ti­ple in­quiries re­gard­ing ob­tain­ing a li­cense to Chugai’s an­ti­body tech­nol­o­gy patents” in 2012 and 2013.

“De­spite know­ing that Chugai did not give Alex­ion per­mis­sion to use Chugai’s re­cy­cling tech­nol­o­gy, and de­spite know­ing that Chugai patent­ed its re­cy­cling tech­nol­o­gy, Alex­ion know­ing­ly in­cor­po­rat­ed Chugai’s tech­nol­o­gy in­to its ALXN1210 prod­uct any­way. Alex­ion’s con­duct amounts to a will­ful dis­re­gard of Chugai’s patent rights,” the com­plaint states.

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.