→ As­traZeneca has won a pri­or­i­ty re­view for its an­ti-CD22 ther­a­py mox­e­tu­momab for hairy cell leukemia. The phar­ma gi­ant can now ex­pect a de­ci­sion on third-line use in the third quar­ter, mark­ing an­oth­er prospec­tive ad­vance for its crit­i­cal­ly im­por­tant on­col­o­gy pipeline.

→ With ma­jor help from Fra­zier Health­care Part­ners, a stealthy gene ther­a­py com­pa­ny from the Uni­ver­si­ty of Penn­syl­va­nia has se­cured $9.29 mil­lion in in­vest­ment. Gene ther­a­py pi­o­neer James Wil­son co-reg­is­tered the com­pa­ny in 2016, the Philadel­phia In­quir­er notes, but has since been re­placed on the board by Penn med­ical school vice dean Kevin Ma­honey. Kr­ish­na Polu, a for­mer Cy­tomX chief med­ical of­fi­cer who joined Fra­zier as an en­tre­pre­neur in res­i­dence, is the CEO. Sev­er­al Fra­zier ex­ecs, in­clud­ing Patrick Heron and Tadata­ka Tama­da, are al­so on the board.

→ Switzer­land’s Glycemi­con an­nounced to­day that af­ter a sec­ond clos­ing, it has raised a to­tal of $5.28 mil­lion (CHF 5.05 mil­lion) to ad­vance cat and hu­man stud­ies of its neu­traceu­ti­cals. The biotech is de­vel­op­ing a pipeline of nov­el food prod­ucts that man­ages pre­di­a­betes, the “gray area” be­tween nor­mal blood sug­ar lev­els and di­a­betes, as well as weight.

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.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

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.

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.

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.”