Antoine Yver (L) and Saurabh Saha

Ahead of Nas­daq de­but, Saurabh Sa­ha pads out the C-suite at Centes­sa, hir­ing a top Dai­ichi Sankyo alum as CMO

Centes­sa is wast­ing no time as­sem­bling the top team in charge of spear­head­ing its port­fo­lio play.

While pre­sum­ably go­ing on vir­tu­al road­shows for its up­com­ing IPO, the biotech put out word that it’s ap­point­ed An­toine Yver, the for­mer head of on­col­o­gy R&D at Dai­ichi Sankyo, as CMO.

Francesco De Ru­ber­tis

With 16 pro­grams in the pipeline — four of which have al­ready reached clin­i­cal stage — that came to­geth­er af­ter Francesco De Ru­ber­tis con­vinced 11 Medicxi star­tups to roll their op­er­a­tions in­to the same com­pa­ny, Yver is sure to hit the ground run­ning. CEO Saurabh Sa­ha clear­ly has no doubt about that, prais­ing his new de­vel­op­ment chief as a “true in­dus­try leader.”

Be­fore join­ing the Japan­ese phar­ma, Yver (a pe­di­atric on­col­o­gist by train­ing) had served as As­traZeneca’s glob­al med­i­cine head of on­col­o­gy, where he was cred­it­ed for lead­ing EGFR in­hibitor Tagris­so’s rapid jour­ney from first hu­man dose to US ap­proval in less than three years. Oth­er no­table drugs on his belt in­clude the PARP in­hibitor Lyn­parza and En­her­tu, the HER2-tar­get­ing an­ti­body-drug con­ju­gate that As­traZeneca bet up to $6 bil­lion on.

The role at Centes­sa will take him far be­yond can­cer. With­in the group of clin­i­cal drugs, there’s an EGFR an­ti­body for cu­ta­neous squa­mous cell car­ci­no­ma and sol­id tu­mors, but the oth­er three are de­signed to treat he­mo­phil­ia, au­to­so­mal dom­i­nant poly­cys­tic kid­ney dis­ease and al­pha-1-an­tit­rypsin de­fi­cien­cy.

Steer­ing these pro­grams to mar­ket (or some kind of deal) AS­AP is a core part of De Ru­ber­tis’ pitch to the en­tre­pre­neurs be­hind each of the sub­sidiaries that agreed to merge in­to Centes­sa.

As the com­pa­ny wrote in its S-1, the founder-sub­ject mat­ter ex­perts “dis­pro­por­tion­ate­ly share in up­side” through mile­stone pay­ments, which would be trig­gered by reg­u­la­to­ry ap­provals or cash pro­ceeds from part­ner­ships, out-li­cens­ing deals and/or a sale.

Gre­go­ry Wein­hoff

For his part, Yver has plen­ty of pos­i­tive things to say about this op­er­at­ing mod­el.

“Centes­sa’s as­set-cen­tric mod­el ex­em­pli­fies the very best prac­tices that I have ex­pe­ri­enced and im­ple­ment­ed in the in­dus­try,” he said in a state­ment.

He joins CFO Gre­go­ry Wein­hoff and chief ad­min­is­tra­tive of­fi­cer David Chao in the C-suite, af­ter Mon­cef Slaoui, the for­mer chief of Op­er­a­tion Warp Speed, quit the CSO job fol­low­ing a sex­u­al ha­rass­ment scan­dal that trig­gered his ejec­tion from all biotech posts.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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.