New­ly named Abeona chief Carsten Thiel boot­ed af­ter the board ac­cus­es him of mis­con­duct in­volv­ing col­leagues

Just 6 months af­ter land­ing the top job at Abeona Ther­a­peu­tics $ABEO, CEO Carsten Thiel has been un­cer­e­mo­ni­ous­ly boot­ed from the ex­ec­u­tive suite, ac­cused of un­spec­i­fied “per­son­al mis­con­duct” in­volv­ing his in­ter­ac­tions with col­leagues at the com­pa­ny.

Ac­cord­ing to Abeona, a cell and gene ther­a­py start­up:

Dr. Thiel’s ter­mi­na­tion fol­lows an in­ves­ti­ga­tion by in­de­pen­dent mem­bers of the Com­pa­ny’s Board of Di­rec­tors and ex­ter­nal coun­sel in­to al­le­ga­tions of mis­con­duct to­wards col­leagues that the Board con­clud­ed vi­o­lat­ed the Com­pa­ny’s Code of Busi­ness Con­duct and Ethics and was in­con­sis­tent with its ex­pec­ta­tions for Abeona’s CEO.

And the sack­ing came with a lec­ture.

“We ex­pect all em­ploy­ees, re­gard­less of ti­tle or re­spon­si­bil­i­ty, to con­duct them­selves eth­i­cal­ly and in ac­cor­dance with com­pa­ny poli­cies, and are com­mit­ted to en­sur­ing an en­vi­ron­ment of re­spect, in­tegri­ty and eth­i­cal con­duct at Abeona,” said ex­ec­u­tive chair­man Steven Rouhan­deh in a pre­pared state­ment.

End­points News reached out to the com­pa­ny to see if we could round up some specifics of what hap­pened, but a spokesper­son was tight-lipped about the de­tails, stick­ing with the state­ment.

João Sif­fert

Thiel had been swept out of his job as com­mer­cial chief at Alex­ion in the spring of 2017 as the then new CEO Lud­wig Hantson cleaned house and brought in his own ex­ec­u­tive crew. Hantson’s ar­rival fol­lowed the de­par­ture of the pre­vi­ous Alex­ion CEO, who had been im­pli­cat­ed in an ethics scan­dal of his own af­ter ques­tions re­gard­ing the way they han­dled ad­vanced sales came up.

He’s be­ing re­placed on an in­ter­im ba­sis by an­oth­er new staffer: R&D chief João Sif­fert, who was brought in just a few weeks ago. Jef­feries notes that Sif­fert ap­pears to have the in­side track on the job, but adds that Abeona will look around for the best re­place­ment.

Pri­or to ABEO, Dr. Sif­fert was CMO at Cere­gene (ac­quired by SG­MO in 2013) and held lead­er­ship roles at AVNR and Av­era with his most re­cent role as Chief Sci­en­tif­ic and Med­ical of­fi­cer for Nes­tle Health Sci­ence. No­tably, he has Board lev­el per­spec­tive at AVXS (was ap­point­ed to the AVXS Board 4/19/17). In gen­er­al, he has ex­pe­ri­ence with neu­ro­log­i­cal drug and gene ther­a­py de­vel­op­ment. With ex­pe­ri­ence from pre­clin to drug ap­proval, Dr. Sif­fert brings a breadth of lead­er­ship-based qual­i­fi­ca­tions that should be rel­e­vant to ABEO’s cur­rent stage of growth. Though Dr. Sif­fert has a head start, ABEO has re­tained a search firm to look ex­ter­nal­ly too.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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