Sarep­ta crit­ic Jenk­ins is ex­it­ing the FDA, and Wood­cock takes di­rect charge of the OND af­ter a painful rup­ture

John Jenk­ins

A few weeks ago, John Jenk­ins, the long­time di­rec­tor of the FDA’s Of­fice of New Drugs, caused quite a stir with some ad­vice for biotechs to avoid the same reg­u­la­to­ry path­way adopt­ed by Sarep­ta, the new win­ner of a con­tro­ver­sial FDA ap­proval for Ex­ondys 51 for Duchenne mus­cu­lar dy­s­tro­phy.

“Path tak­en by Sarep­ta NOT a good mod­el for oth­er de­vel­op­ment pro­grams,” de­clared one of Jenk­ins’ talk­ing points un­der a fi­nal sec­tion marked “lessons learned” from eteplirsen and oth­er cas­es.

In the fu­ture, he not­ed in his pre­sen­ta­tion, de­vel­op­ers would be held to a high stan­dard when it came to new mar­ket­ing ap­provals; Sarep­ta was the ex­cep­tion that proved the rules. And any­one who thought about fol­low­ing Sarep­ta’s path at the FDA, he added, was go­ing down the wrong trail.

This morn­ing, though, CDER di­rec­tor and Sarep­ta cham­pi­on Janet Wood­cock spread the word that Jenk­ins is re­tir­ing from the FDA in ear­ly Jan­u­ary — and she’s tem­porar­i­ly as­sum­ing his po­si­tion.

Janet Wood­cock

“We will con­duct a na­tion­al search to fill John’s po­si­tion,” Wood­cock notes, af­ter a lengthy sum­ma­ry of his work at the agency. “Dur­ing this time of tran­si­tion, I will serve as act­ing di­rec­tor of OND. I will con­tin­ue to en­gage in dis­cus­sions with OND staff and work close­ly with OND lead­ers as we work to­geth­er to ad­dress sci­en­tif­ic ad­vances that will im­pact the new drug re­view pro­gram in the com­ing years.”

Jenk­ins’ de­par­ture comes af­ter a bru­tal show­down be­tween Wood­cock and top of­fi­cials at the FDA who fought hard against the ap­proval of Ex­ondys 51. Sarep­ta, its crit­ics say, nev­er came close to pro­vid­ing clear ev­i­dence of ef­fi­ca­cy and safe­ty for eteplirsen. But in the end, Com­mis­sion­er Robert Califf opt­ed to de­fer to the pow­er­ful Wood­cock, over­rul­ing the ob­jec­tions and deep split in­side the FDA about its role in su­per­vis­ing this ap­proval process.

Wood­cock has sig­naled her sup­port of tak­ing a more flex­i­ble ap­proach to drug ap­provals, leav­ing some tra­di­tion­al­ists aghast. But no mat­ter how peo­ple sided in the civ­il war that di­vid­ed reg­u­la­tors on Sarep­ta, there’s no doubt that Wood­cock’s al­ready con­sid­er­able clout at the FDA just grew by sev­er­al de­grees, leav­ing her in a po­si­tion to re­form the OND on her own terms as the FDA preps for the ar­rival of Don­ald Trump at the White House.

The most im­me­di­ate im­pact of Jenk­ins’ de­par­ture will be Wood­cock’s in­creased au­thor­i­ty at the FDA, says Michael Ga­ba, the fed­er­al pol­i­cy leader of the firm’s life sci­ences team at Hol­land & Knight. But the longterm fall­out may have pro­found im­pli­ca­tions for the bio­phar­ma busi­ness.

“There’s an in­ter­est­ing con­flu­ence of events tak­ing place that may very well shape the FDA’s fu­ture un­der the next Ad­min­is­tra­tion,” he notes in an email mes­sage. “I would agree that the Jenk­ins de­par­ture cer­tain­ly sig­nals a near-term con­sol­i­da­tion of Janet Wood­cock’s au­thor­i­ty at CDER. How that plays out will be a func­tion of who is se­lect­ed to serve as the next FDA Com­mis­sion­er.”

But, he adds, if the FDA al­lows more com­pa­nies to fol­low Sarep­ta’s lead, they could be set­ting the stage for a dam­ag­ing ero­sion of pub­lic con­fi­dence in the FDA — which the in­dus­try ben­e­fits from.

“I ex­pect that the op­po­si­tion ex­pressed by Jenk­ins and oth­ers with­in the FDA lead­er­ship around the Sarep­ta ap­proval will con­tin­ue among drug re­view­ers as they are bound to en­sure prod­ucts are safe and ef­fec­tive for their in­tend­ed use as sup­port­ed by sci­en­tif­ic da­ta,” Ga­ba adds. “And I think the drug in­dus­try has to be care­ful here. I can ap­pre­ci­ate that any one drug com­pa­ny may want to press its prod­uct through with fast track au­thor­i­ty when it can, and do so with the help of pa­tient ad­vo­cates. But as more drug de­vel­op­ers are suc­cess­ful in this man­ner, then the val­ue of an FDA ap­proval could very well be di­min­ished as post-mar­ket ad­verse events in­crease in the ab­sence of sol­id up-front end-point based sci­en­tif­ic da­ta. This could, over time I sus­pect, tar­nish the FDA’s ‘good house­keep­ing seal of ap­proval’ that in­dus­try as a whole should want to up­hold.”

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

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Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.