Masks are com­ing off, restau­rants are fill­ing up again in­doors, and the US is, by all ac­counts, re­turn­ing to some sort of nor­mal-ish state.

But as the Covid-19 death toll slow­ly ticks up to the 600,000 mark, there’s a grow­ing con­sen­sus that at least some of those lives could’ve been saved. Where and how the past ad­min­is­tra­tion went wrong is easy to di­ag­nose as an arm­chair ex­pert, but Con­gress needs to be­gin what will like­ly be a gar­gan­tu­an and long process of ac­tu­al­ly sift­ing through the da­ta, in­ter­nal emails and de­ci­sion mak­ing to see what ex­act­ly hap­pened and what needs to be cor­rect­ed mov­ing for­ward.

With the help of the Free­dom of In­for­ma­tion Act, the pub­lic can now see a tiny glimpse of what some of the top health of­fi­cials in the Trump ad­min­is­tra­tion were do­ing at the height of the pan­dem­ic, and it isn’t pret­ty.

First and fore­most, the emails show how for­mer FDA com­mis­sion­er Steve Hahn lied to the pub­lic when he apol­o­gized for mis­s­peak­ing dur­ing a press con­fer­ence about how con­va­les­cent plas­ma would in­crease sur­vival. He didn’t mis­s­peak, his email shows he was plan­ning to note the 35% over­all in­crease in sur­vival all along.

And rather than of­fer­ing sup­port for what must’ve been a gru­el­ing sev­er­al months at the be­gin­ning of 2020 for those top ad­vi­sors like Deb­o­rah Birx and Hahn, se­nior Trump ap­pointees like Hope Hicks and Joe Gro­gan were in­stead push­ing their own agen­das, seek­ing fa­vors and mak­ing per­son­al ap­peals and de­mands — of­ten times for drugs like hy­drox­y­chloro­quine, which proved to be com­plete­ly in­ef­fec­tive.

And why was Katie Miller, the for­mer com­mu­ni­ca­tions di­rec­tor for Vice Pres­i­dent Mike Pence with no pub­lic health or med­ical ex­pe­ri­ence, telling Hahn what to look in­to ther­a­peu­tic-wise in April 2020?

Emails from a month pri­or to the Miller de­mand al­so show how celebri­ties with ac­cess to the top of­fi­cials (like Dr. Oz and Lau­ra In­gra­ham) were not on­ly grant­ed an au­di­ence but al­so mak­ing de­mands on how to run tri­als for hy­drox­y­chloro­quine.

Aaron Kessel­heim

And this is just the tini­est sliv­er of the ice­berg that Con­gress needs to look in­to and re­lease pub­licly, not on­ly for those who died of Covid-19 and their fam­i­lies, but for the next ad­min­is­tra­tion that has to deal with a sim­i­lar­ly mas­sive, time-sen­si­tive is­sue like this.

Tax­pay­er dol­lars shouldn’t be wast­ed on what celebri­ties think, par­tic­u­lar­ly dur­ing a pan­dem­ic.

Aaron Kessel­heim, pro­fes­sor of med­i­cine at Har­vard Med­ical School, put it best when he told me re­cent­ly, “I was most hor­ri­fied by the at­tempts by mem­bers of the Trump ad­min­is­tra­tion/Con­gress and celebri­ties to get fa­vors or make per­son­al ap­peals to the FDA Com­mis­sion­er, and to see such mi­nor, use­less stuff be el­e­vat­ed up to the high­est lev­els of the FDA.

“If com­mu­ni­ca­tions like this were more rou­tine­ly made pub­licly avail­able, then maybe such folks would feel less en­ti­tled to make them, and all of the peo­ple who re­ly on the FDA would bet­ter trust that cer­tain de­ci­sions were be­ing made on sci­en­tif­ic terms rather than po­lit­i­cal (or Dr. Oz’s!) in­ter­fer­ence,” he added.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.