HHS Xavier Becerra (AP Images)

Rule­mak­ing au­thor­i­ty re­stored at FDA as a show of sup­port in a tu­mul­tuous time

Just a day af­ter two top ca­reer vac­cine lead­ers at FDA re­tired at a key mo­ment of the pan­dem­ic, HHS has now for­mal­ly re­versed a ques­tion­able Trump-era memo that had abol­ished FDA’s abil­i­ty to write new rules.

That memo from then-HHS Sec­re­tary Alex Azar, is­sued Sept. 15, 2020, re­scind­ed “any pri­or del­e­ga­tion of rule­mak­ing au­thor­i­ty” at the FDA. On Wednes­day, how­ev­er, HHS Sec­re­tary Xavier Be­cer­ra is­sued a del­e­ga­tion that re­voked the 2020 memo as it ap­plies to FDA, and re­in­stat­ed any del­e­ga­tions to FDA re­scind­ed by the memo.

Ef­fec­tive­ly, the move is a show of sup­port from HHS’ top po­lit­i­cal ap­pointee, restor­ing FDA’s au­ton­o­my to the pre-Trump days, and paving the way for FDA to con­tin­ue its rule­mak­ing agen­da, which typ­i­cal­ly in­volves rule­mak­ings to en­sure the safe­ty of med­ical prod­ucts and im­prov­ing pub­lic health.

“Good to see HHS re­vers­ing pol­i­cy de­ci­sion by their pre­de­ces­sors that would have great­ly lim­it­ed FDA’s dis­cre­tion to is­sue pub­lic health reg­u­la­tions,” for­mer FDA com­mis­sion­er and Pfiz­er board mem­ber Scott Got­tlieb, wrote on Twit­ter. “This de­ci­sion by cur­rent HHS will re­store an es­sen­tial el­e­ment of FDA’s in­de­pen­dent judge­ment and al­low the agency to act faster.”

The fig leaf from HHS comes as FDA con­tin­ues to reel from the de­par­ture of two key vac­cine lead­ers while grap­pling with a press­ing time­line on Covid-19 vac­cine boost­ers and chil­dren’s vac­cines lat­er this fall and win­ter.

Azar’s HHS claimed in 2020 that the memo was nec­es­sary be­cause while in some cas­es rules were signed by the HHS sec­re­tary and by the head of the agency in­volved, in oth­er cas­es, oth­er of­fi­cials to whom au­thor­i­ty had been del­e­gat­ed signed the rules.

Got­tlieb told CBS’ Face the Na­tion on Sept. 20, 2020 that the memo was a “a ma­jor dis­trac­tion” from Covid-19 re­lief ef­forts, and it could call in­to ques­tion all of the rules that were signed by low­er-lev­el peo­ple who were del­e­gat­ed to sign the rules. He said when he was com­mis­sion­er at FDA, he re-cod­i­fied the to­bac­co deem­ing rule be­cause the agency feared some­thing like this might oc­cur.

Mark Mc­Clel­lan, for­mer FDA com­mis­sion­er and now head of Duke Uni­ver­si­ty’s health pol­i­cy cen­ter, told the New York Times at the time, “We’re in the midst of a pan­dem­ic, when trust in the pub­lic health agency is need­ed more than ever. So, I’m not sure what is to be gained with a man­age­ment change with re­spect to FDA when they are do­ing such crit­i­cal work.”

In ad­di­tion to this re­ver­sal, Biden’s HHS has re­versed a few oth­er FDA-re­lat­ed Trump-era ini­tia­tives, in­clud­ing de­ci­sion to pull the FDA’s con­tro­ver­sial Un­ap­proved Drugs Ini­tia­tive, an­oth­er no­tice that would’ve re­quired the FDA to pub­lish re­dun­dant in­for­ma­tion on the time­lines for re­view­ing drug ap­pli­ca­tions, and two re­quests for pro­pos­als on the reim­por­ta­tion of in­sulin and the per­son­al im­por­ta­tion of pre­scrip­tion drugs.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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