The fi­nal reg­u­la­to­ry hur­dle for As­traZeneca’s mega-merg­er with Alex­ion Phar­ma­ceu­ti­cals has been cleared, paving the way for the deal to close as soon as next week.

Britain’s fi­nan­cial watch­dog, The UK Com­pe­ti­tion & Mar­kets Au­thor­i­ty, has rub­ber stamped As­traZeneca’s $39 bil­lion takeover of the Boston-based rare dis­ease biotech, the com­pa­nies an­nounced Wednes­day morn­ing. As a re­sult, the trans­ac­tion is ex­pect­ed to close on Ju­ly 21, with Alex­ion shares $ALXN be­ing con­vert­ed to As­traZeneca stock $AZN and re­moved from Nas­daq the next day.

Shares will al­so be ad­mit­ted to the Lon­don Stock Ex­change and Nas­daq Stock­holm, the two mar­kets of As­traZeneca’s home coun­tries of the UK and Swe­den. Once the merg­er is wrapped up, Alex­ion will es­sen­tial­ly be­come As­traZeneca’s en­tire rare dis­ease unit with block­buster Soliris and fol­low-up drug Ul­tomiris com­ing on board.

Marc Dunoy­er

“We are very pleased to have se­cured this crit­i­cal fi­nal clear­ance,” As­traZeneca CFO Marc Dunoy­er said in a state­ment. “We look for­ward to the im­mi­nent clos­ing of the trans­ac­tion so that we may pur­sue our shared am­bi­tion to bring more in­no­v­a­tive med­i­cines to pa­tients world­wide and be­gin As­traZeneca’s next chap­ter of growth.”

While ques­tions sur­round­ed the merg­er back when it was an­nounced in De­cem­ber 2020, CEO Pas­cal So­ri­ot has out­lined a vi­sion for As­traZeneca to pave a new path in rare dis­eases for the first half of the next decade. With a par­tic­u­lar fo­cus on im­munol­o­gy, he’s said he ex­pects Alex­ion to help dri­ve growth in the field to the tune of dou­ble dig­it rev­enue through 2025.

The rosy pro­jec­tions still have to per­form, how­ev­er, and many are like­ly to scru­ti­nize the pipeline As­traZeneca is ac­quir­ing in the deal. An­dexxa, one of Alex­ion’s ap­proved med­i­cines to treat acute­ly un­con­trolled bleed­ing of Fac­tor Xa in­hibitors, re­turned dis­ap­point­ing sales num­bers and proved piv­otal in mount­ing ac­tivist pres­sure on CEO Lud­wig Hantson in 2020.

Lud­wig Hantson

Dunoy­er, who will lead the new Alex­ion sub­sidiary when the deal is com­plete, told End­points News in an in­ter­view last month that As­traZeneca doesn’t plan to auc­tion off An­dexxa, and in­stead hopes to turn it around in a sim­i­lar fash­ion to the drug­mak­er’s Bril­in­ta drug.

Of course, it does help that As­traZeneca will im­me­di­ate­ly ben­e­fit from Soliris, which raked in more than $4 bil­lion in sales in 2020, as well as Ul­tomiris, the planned suc­ces­sor for Soliris. Alex­ion has po­si­tioned Ul­tomiris to soak up most of the sales from the old­er drug once it hits its patent cliff lat­er this decade, de­spite some new com­pe­ti­tion.

Wednes­day’s green­light from the UK was large­ly ex­pect­ed fol­low­ing the FTC sign­ing off on the deal in April and the EU sig­nal­ing its ap­proval last week. The FTC re­view came de­spite Pres­i­dent Joe Biden’s ad­min­is­tra­tion say­ing it would take a harsh­er stance on Big Phar­ma merg­ers in March, but none of the feared an­titrust mea­sures came to pass.

One rea­son may have been the lack of a pipeline over­lap be­tween the two com­pa­nies, ac­cord­ing to an analy­sis from Eval­u­ate Phar­ma at the time. None of the com­pa­nies’ mar­ket­ed drugs have any crossover in in­di­ca­tions, and the on­ly pipeline can­di­date that could be seen as sim­i­lar is Alex­ion’s cer­du­la­tinib — a po­ten­tial in­ter­sec­tion with As­traZeneca’s blood can­cer fran­chise.

And while the Alex­ion deal had been viewed by some as a po­ten­tial bell­wether for the in­dus­try, the FTC has been harsh­er on oth­er com­pa­nies so far this year. The com­mis­sion has sued to block Il­lu­mi­na’s $8 bil­lion buy­out of Grail, ex­press­ing con­cerns over Il­lu­mi­na’s po­ten­tial stran­gle­hold on the DNA se­quenc­ing mar­ket.

The Il­lu­mi­na merg­er is run­ning up against new head­winds as well, with the EU ex­pect­ed to launch a full-scale an­titrust probe at the end of its re­view next week, Reuters re­port­ed Tues­day.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.