HHS post­pones re­view of over 95% of FDA’s reg­u­la­tions so crit­i­cal re­sources are not di­vert­ed from Covid-19

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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

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.

Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA (Sipa via AP Images))

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

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.

Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

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.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

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 names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

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.

Paul Hudson, Sanofi CEO (Photographer: Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

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.

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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