→ 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.

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.