→ 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.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.