The EMA of­fi­cial­ly va­cates its Lon­don HQ — next stop Am­s­ter­dam; CHMP backs ap­proval of 8 drugs

→ The EMA of­fi­cial­ly said good­bye to its Ca­nary Wharf head­quar­ters in Lon­don on Fri­day, to set up shop in Am­s­ter­dam — a de­ci­sion trig­gered by Britain’s 2016 de­ci­sion to leave the EU.

To­day we are clos­ing our Lon­don of­fices af­ter al­most a quar­ter of a cen­tu­ry. Thank you, Lon­don for be­ing such a gra­cious host! https://t.co/R8LXjfzvp3 pic.twit­ter.com/8abqM­cbROJ

— EU Med­i­cines Agency (@EMA_News) March 1, 2019

→ The EU reg­u­la­tor al­so is­sued pos­i­tive rec­om­men­da­tions for a slate of treat­ments, list­ed be­low:

EMA’s hu­man med­i­cines com­mit­tee rec­om­mends 8 #med­i­cines for ap­proval at its Feb­ru­ary 2019 meet­ing https://t.co/VCEd­e­qi­Aar #CHMP pic.twit­ter.com/0Z1cC­N­fkng

— EU Med­i­cines Agency (@EMA_News) March 1, 2019

• Sanofi/Re­gen­eron‘s Dupix­ent for se­vere asth­ma, set­ting up the ex­pan­sion of the med­i­cine’s la­bel, which cur­rent­ly cov­ers atopic der­mati­tis
• Sanofi $SNY had an­oth­er en­dorse­ment, for its di­a­betes drug so­tagliflozin, to be sold un­der the brand name Zyn­quista
• Bio­Marin Phar­ma­ceu­ti­cals $BM­RN has won back­ing for peg­valiase, which has been dubbed Pa­lynz­iq, for phenylke­tonuria, a rare but po­ten­tial­ly se­ri­ous in­her­it­ed meta­bol­ic dis­ease
• The agency en­dorsed grant­i­ng a con­di­tion­al mar­ket­ing au­tho­riza­tion for Akcea’s volane­sors­en — to be sold as Waylivra — as the first med­i­cine to treat fa­mil­ial chy­lomi­cron­aemia syn­drome, a rare ge­net­ic dis­ease that thwarts the body from break­ing down fats
• An­oth­er con­di­tion ap­proval was rec­om­mend­ed for Por­to­la Phar­ma­ceu­ti­cals’ $PT­LA an­dex­anet al­fa, brand­ed as On­dexxya — an an­ti­dote for pa­tients on cer­tain clot-fight­ers, when the use of the an­ti­co­ag­u­lants leads to life-threat­en­ing or un­con­trolled bleed­ing
• Ab­b­Vie $AB­BV se­cured rec­om­men­da­tion for risankizum­ab — brand­ed as Skyrizi — for plaque pso­ri­a­sis

These rec­om­men­da­tions fol­lowed two oth­ers from Thurs­day:

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