Joe Todisco, new CorMedix CEO

Ahead of sec­ond FDA chance, CorMedix winds down Eu­ro­pean busi­ness

The bear mar­ket struck again Thurs­day morn­ing as a New Jer­sey-based an­ti­fun­gal biotech re­port­ed a sig­nif­i­cant shift in op­er­a­tions.

CorMedix will be shak­ing up much of its C-suite and halt­ing op­er­a­tions in Eu­rope, the com­pa­ny an­nounced, as it looks to re­bound from a March 2021 CRL. The com­pa­ny had re-filed its ap­pli­ca­tion about six weeks ago but the changes high­light the new di­rec­tion as it pre­pares to meet the FDA once again.

The most promi­nent change comes at the top: Joe Todis­co of­fi­cial­ly start­ed his CEO tenure Tues­day, fol­low­ing the an­nounce­ment of his ap­point­ment back in March. Tom Nus­bick­el, mean­while, will step down from his role as chief com­mer­cial of­fi­cer in a mu­tu­al part­ing of ways, CorMedix said.

Ad­di­tion­al­ly, as CorMedix winds down its Eu­ro­pean busi­ness, it will al­so dis­con­tin­ue the dis­tri­b­u­tion of Neu­trolin, used to pre­vent catheter-re­lat­ed blood in­fec­tions. Neu­trolin is the com­pa­ny’s on­ly ap­proved prod­uct and is on­ly ap­proved in Eu­rope.

The new fo­cus, at least in the short term, will be se­cur­ing ap­proval of the de­vice in the US, where it’s known as De­fen­Cath. Oth­er hires and pro­mo­tions in­clude a new ex­ec­u­tive VP of clin­i­cal op­er­a­tions, a se­nior VP and head of glob­al qual­i­ty and a VP of sup­ply chain.

“I am ex­cit­ed to be­gin my tenure this week at CorMedix,” Todis­co said in a state­ment. “The new hires we an­nounced add sig­nif­i­cant ex­per­tise in qual­i­ty, man­u­fac­tur­ing and sup­ply chain, and join a high­ly skilled team of pro­fes­sion­als who I have had the priv­i­lege of get­ting to know over the past sev­er­al weeks.”

Todis­co’s new role comes af­ter CorMedix’s for­mer CEO, Khoso Baluch, re­tired last Oc­to­ber af­ter more than five years run­ning the show. Baluch hung it up about a month af­ter de­lays at a con­tract man­u­fac­tur­er led to the re­sub­mis­sion of De­fen­Cath’s NDA.

CorMedix had pre­vi­ous­ly said it has sched­uled a new in­spec­tion and be­lieves it will sat­is­fy reg­u­la­tor con­cerns once they re­view the new pitch.

The biotech is far from the on­ly com­pa­ny to change up its C-suite in re­cent months as the mar­ket down­turn af­fects more and more com­pa­nies. The XBI, the com­pos­ite mea­sure­ment of the biotech sec­tor, was down an­oth­er sev­er­al per­cent­age points Wednes­day, but is up about 3% in Thurs­day’s ear­ly ses­sion.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na chief Ban­cel to do­nate about $355M worth of ear­ly stock to char­i­ty

Four days ago, Moderna CEO Stéphane Bancel was made a Chevalier — basically knighted — in his home country of France. And now the billionaire CEO said he will exercise and donate about  $355 million in stock options.

Bancel announced early Tuesday via a blog post that he and his wife Brenda will be donating the after-tax proceeds of his original stock options to charity — the stock options Bancel was granted back in 2013 after he became CEO, two years after he first joined the mRNA specialist outfit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

David Sinclair, Genocea Biosciences co-founder (Alpha Wave Global)

Geno­cea reach­es end of road, delist­ing from Nas­daq and let­ting go of re­main­ing staff

A pivot into neoantigen immunotherapies was not enough to save Genocea Biosciences after all.

The 16-year-old biotech said it would be closing down and laying off all remaining employees “except those deemed necessary to complete an orderly wind down” of operations. It has also delivered a formal notice to Nasdaq, notifying the stock exchange of its intent to delist voluntarily.

The move comes a month after Genocea laid off 75% of its workforce and revealed it’s looking for strategic alternatives, such as a sale, merger or reverse merger. At the end of 2021, it had 74 employees.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.