→ Ul­tragenyx’s Crysvi­ta has scored its sec­ond FDA ap­proval, earn­ing the nod to treat bone soft­en­ing in pa­tients with the ul­tra-rare dis­ease known as tu­mor-in­duced os­teo­ma­la­cia. First ap­proved in 2018 for a dif­fer­ent ul­tra-rare in­di­ca­tion, x-linked hy­pophos­phatemia, Crysvi­ta quick­ly earned watch­dog scorn for its $200,000 per year price tag. De­spite hopes, though, that the price would bring block­buster sales, it earned on­ly $87.3 mil­lion last year and $28.8 mil­lion in Q1 2020. The drug is al­so mar­ket­ed by Japan­ese biotech Ky­owa Kirin.

→ Sanofi and Re­gen­eron’s IL-3/IL-14 block­buster Dupix­ent has been ap­proved in Chi­na for atopic der­mati­tis. CEO Paul Hud­son said that as part of the gov­ern­ment’s Healthy Chi­na 2030 ini­tia­tive, the French phar­ma will seek 25 new ap­provals by 2025.

→ Sagimet Bio­sciences re­leased pos­i­tive Phase II da­ta for its NASH drug TVB-2640. Al­though the field has strug­gled de­spite great in­vestor and in­dus­try promise, most re­cent­ly with the fail­ure of Gen­Fit’s close­ly-watched Phase III tri­al, a steady pipeline of ear­li­er stage drugs con­tin­ue to march along. Sagimet, known as 3-V Bio­sciences un­til last Au­gust, said the drug’s high dose had a 61% re­sponse rate across 30 pa­tients and led to a mean liv­er fat re­duc­tion of 28.2%.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.

AstraZeneca’s big gamble on Daiichi Sankyo’s antibody-drug conjugate Enhertu has already paid off with a big approval in breast cancer more than a year ago. But the partners have big plans for their blockbuster in the making, and a new nod in gastric cancer will raise their spirits even higher.

The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.

Close to 70 years after Oxford scientists purified penicillin and confirmed its effect as an antibacterial drug, the university is establishing a new research institute at the forefront of combating antimicrobial resistance.

The Ineos Oxford Institute for AMR Research will initially be powered by a $136 million (£100 million) donation from Ineos, the UK-based chemicals giant founded by billionaire Jim Ratcliffe, that also plays a hand in manufacturing medical and pharma products.