→ 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:

• GSK’s $GSK zanamivir — to be sold as Dec­to­va— for com­pli­cat­ed and po­ten­tial­ly life-threat­en­ing in­fluen­za
• Pfiz­er $PFE se­cured back­ing for con­di­tion­al ap­proval of lor­la­tinib — brand­ed as Lorvi­qua — to treat a form of non-small cell lung can­cer

→ Un­der fire from Star­board and Welling­ton — which have made their op­po­si­tion against the $74 bil­lion buy­out of Cel­gene $CELG abun­dant­ly clear — Bris­tol-My­ers $BMY has been try­ing to shore up in­vestor sup­port be­hind-the-scenes, CN­BC re­port­ed on Fri­day. The re­port sug­gest­ed Bris­tol had sent ex­ec­u­tives to New York to meet with in­sti­tu­tion­al in­vestors sev­er­al times over the last two weeks and met with in­vestors in Boston on Wednes­day and Thurs­day, cit­ing a per­son briefed on the meet­ings.

→  UK-based AdoRx Ther­a­peu­tics has tied up with J&J $JNJ to de­vel­op lung can­cer drugs in a deal with undis­closed fi­nan­cial terms.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).