The De­part­ment of Health and Hu­man Ser­vices said late Thurs­day that it’s post­pon­ing a last-minute rule en­act­ed by for­mer Pres­i­dent Trump’s HHS that would’ve re­quired the FDA to re­view al­most every one of its reg­u­la­tions, which would’ve di­vert­ed nec­es­sary re­sources away from the agency’s on­go­ing work on the pan­dem­ic.

“Based on a count cit­ed in the SUN­SET fi­nal rule, un­der the time­line and de­f­i­n­i­tions pro­vid­ed in the fi­nal rule, over 7,000 sec­tions of the Code of Fed­er­al Reg­u­la­tions pro­mul­gat­ed by the Food and Drug Ad­min­is­tra­tion (FDA) are more than ten years old or would be­come more than ten years old dur­ing the first five years the rule would be in ef­fect, rep­re­sent­ing over 95 per­cent of its cur­rent reg­u­la­tions,” HHS said in an­nounc­ing the post­pone­ment.

HHS al­so said in its Fed­er­al Reg­is­ter no­tice that if the sun­set fi­nal rule be­came ef­fec­tive as sched­uled on March 22, then to avoid au­to­mat­ic ex­pi­ra­tion of these reg­u­la­tions, FDA and HHS “would need to im­me­di­ate­ly di­vert re­sources to­ward as­sess­ment and re­view dur­ing the on­go­ing COVID-19 pub­lic health emer­gency. In that event, FDA’s re­views of med­ical prod­uct ap­pli­ca­tions, ful­fill­ment of user fee com­mit­ments, and ac­tions to ad­dress ur­gent pub­lic health mat­ters such as on­go­ing COVID-19 pan­dem­ic re­lief ef­forts, out­breaks of food­borne ill­ness, in­spec­tions, re­calls, and oth­er pub­lic health pri­or­i­ties would be sig­nif­i­cant­ly im­pact­ed.

“This con­cen­tra­tion of re­sources in con­duct­ing reg­u­la­to­ry re­view pur­suant to the SUN­SET rule could pre­vent FDA from mod­ern­iz­ing its reg­u­la­to­ry over­sight more ef­fi­cient­ly and ad­dress­ing new reg­u­la­to­ry needs,” HHS added, not­ing that it’ll de­lay the ef­fec­tive date of the rule by a year.

The de­part­ment al­so said that it thinks a re­cent law­suit from the Cen­ter for Sci­ence in the Pub­lic In­ter­est and oth­er groups to over­turn the rule has some mer­its, and that this ex­ten­sion will al­low the suit to pro­ceed.

“Based on HHS’s ini­tial re­view of the Com­plaint, HHS be­lieves that the Court could find mer­it in some of Plain­tiffs’ claims,” HHS said. “Plain­tiffs’ al­le­ga­tions of harm are cred­i­ble; a post­pone­ment will per­mit HHS to re­view the SUN­SET fi­nal rule in light of the claims raised in the lit­i­ga­tion; and the bal­ance of eq­ui­ties and the pub­lic in­ter­est war­rant post­pone­ment of the ef­fec­tive date to pre­serve the sta­tus quo while the Court con­sid­ers the chal­lenge to the SUN­SET fi­nal rule.”

If the suit does not halt the rule, the Biden ad­min­is­tra­tion could just with­draw it, ex­perts pre­vi­ous­ly told End­points News, al­though HHS would still need to go through a no­tice-and-com­ment pro­ce­dure to do so.

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the passenger seat.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would eliminate a federal mandate for animal testing for new drugs.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.

Today the Senate unanimously passed my bipartisan FDA Modernization Act 2.0 to end animal testing mandates! This is an important step toward innovation and ending the needless suffering and death of animal test subjects. pic.twitter.com/vGpCCdpuOf

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Sanofi chief executive Paul Hudson told investors earlier this year that the Big Pharma was going to emphasize its sales kingpin Dupixent moving forward.

He wasn’t joking — the megablockbuster drug and sales king, recording just shy of $2 billion in sales this past quarter, has now officially secured its fifth indication from the FDA.

Sanofi and Regeneron, who jointly work on Dupixent development and commercialization, announced the new development on Thursday, saying that the FDA gave the all-clear to Dupixent to treat patients with prurigo nodularis, a rare autoimmune disorder characterized by a persistent, severe itch — and also visualized by hard, extremely itchy bumps known as nodules that form on the skin. The FDA noted in its announcement that it is the agency’s first approval for the disease.