FDA names new No. 2 to re­place re­tir­ing Sher­man

The US Food and Drug Ad­min­is­tra­tion (FDA) an­nounced Mon­day that Dr. Amy Aber­nethy will re­place Rachel Sher­man as Prin­ci­pal Deputy com­mis­sion­er of Food and Drugs – the high­est po­si­tion at the agency that is not a po­lit­i­cal ap­pointee.

Amy Aber­nathy

Aber­nethy is the for­mer chief med­ical of­fi­cer, chief sci­en­tif­ic of­fi­cer and se­nior vice pres­i­dent, on­col­o­gy, at Flat­iron Health, which is a unit of Roche. Pri­or to that she was a pro­fes­sor of med­i­cine at Duke Uni­ver­si­ty School of Med­i­cine and ran the Cen­ter for Learn­ing Health Care in the Duke Clin­i­cal Re­search In­sti­tute and Duke Can­cer Care Re­search Pro­gram in the Duke Can­cer In­sti­tute.

FDA Com­mis­sion­er Scott Got­tlieb wrote in a memo to FDA staff an­nounc­ing Aber­nethy’s ap­point­ment “She’s a high­ly re­gard­ed thought leader who has held nu­mer­ous po­si­tions of lead­er­ship in her fields of in­ter­est and dis­tin­guished her­self for her in­tel­lect, her pas­sion for pa­tient care and sci­ence, and her col­le­gial­i­ty.”

Ellen Si­gal, Chair and Founder of Friends of Can­cer Re­search, added: “As a treat­ing physi­cian, not on­ly does she know first-hand the im­por­tance and pow­er of the im­pact the FDA has on pa­tients every day, but she has shown in her many lead­er­ship ca­pac­i­ties that in or­der to make true ad­vances, and save lives, you must al­ways in­no­vate with the pa­tient at the fore­front. This ap­point­ment, in many ways, is a nat­ur­al pro­gres­sion from the piv­otal work that Rachel Sher­man has paved the way for since her re­turn to FDA in 2015.”

Dr. Sher­man is re­tir­ing from FDA in Jan­u­ary af­ter serv­ing at the agency since 1989. Af­ter 15 years of in­creas­ing re­spon­si­bil­i­ty in CDER, in 2005, Dr. Sher­man moved to FDA’s Of­fice of the Com­mis­sion­er, be­com­ing As­so­ci­ate Com­mis­sion­er for Clin­i­cal Pro­grams and di­rect­ing FDA’s Crit­i­cal Path Ini­tia­tive.

She lat­er re­turned to CDER in 2009 and served as CDER’s As­so­ci­ate Cen­ter Di­rec­tor for Med­ical Pol­i­cy and Di­rec­tor of the Of­fice of Med­ical Pol­i­cy, be­fore tak­ing over in her cur­rent po­si­tion af­ter a brief re­tire­ment in 2015.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

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.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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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 cockpit.

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.

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.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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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.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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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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