Long­time Sanofi R&D chief Elias Zer­houni is on his way out, hand­ing the re­search reins to Roche vet John Reed

Af­ter 7 years as head of Sanofi R&D, for­mer NIH chief Elias Zer­houni is step­ping down and hand­ing the job to John Reed, who spent the last 5 years run­ning Roche’s pRED re­search group based in Basel.

A spokesper­son for Sanofi tells me that Reed, like Zer­houni, will have of­fices in Cam­bridge, MA and Paris.

John Reed

The change at the top of the Paris-based phar­ma gi­ant’s re­search arm marks the lat­est in a se­ries of switch-ups in the world’s biggest phar­ma R&D or­ga­ni­za­tions, with Hal Bar­ron tak­ing over at Glax­o­SmithK­line, Dan Skovron­sky step­ping up at Eli Lil­ly and John Tsai tak­ing charge of de­vel­op­ment at No­var­tis. 

Dur­ing Zer­houni’s tenure Sanofi lined up a fruit­ful al­liance with Re­gen­eron that de­liv­ered some ma­jor new ther­a­pies, with an­oth­er PD-1 check­point on the way. Sanofi al­so ac­quired Gen­zyme. And Zer­houni fol­lowed up with an im­por­tant al­liance with Al­ny­lam and re­cent ac­qui­si­tion deals for Biover­atv and Abl­ynx. But Sanofi’s own R&D or­ga­ni­za­tion has been slow and in­ef­fec­tive in mak­ing much head­way in drug de­vel­op­ment, though Zer­houni has in­sist­ed that has been chang­ing as well.

Sanofi spent $6.7 bil­lion on R&D last year, with a 6th place rank­ing among the world’s biggest drug re­search op­er­a­tions.

Reed, who was brought in from San­ford-Burn­ham for the job of fin­ish­ing the over­haul at pRED, has had lit­tle to boast about dur­ing his tenure at Roche, where he re­cent­ly ex­it­ed. Roche has re­lied on Genen­tech — gRED — to pro­duce the com­pa­ny’s new block­busters.

Both Reed and Zer­houni are known as in­flu­en­tial sci­en­tists with a keen un­der­stand­ing of trans­la­tion­al re­search. But they’ve nev­er made the leap to be­come known for mas­ter­ing de­vel­op­ment on their own.

Reed is join­ing Sanofi April 30, two months be­fore Zer­houni leaves Sanofi. 

“John is an ac­com­plished and wide­ly rec­og­nized physi­cian-sci­en­tist with a bril­liant aca­d­e­m­ic track record,” said Sanofi CEO Olivi­er Brandi­court in a state­ment. “He is ex­pe­ri­enced in dri­ving R&D pro­duc­tiv­i­ty, build­ing high-per­form­ing teams and in­te­grat­ing biotech com­pa­nies to pro­vide new tech­nol­o­gy plat­forms.”

Michel Younatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application.

The big biotech also notes that the “FDA has stated that, if possible, it plans to act early on this application under an expedited review.”

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: No­vavax inks vac­cine deals with Japan and In­dia; As­traZeneca near­ing agree­ments with Japan and Brazil

Following the release this week of promising early data for their Covid-19 vaccine candidate, Novavax has announced collaborations to supply it to two countries — Japan and India.

The Maryland-based biotech announced a deal Friday morning with Takeda to develop and manufacture up to 250 million doses per year of its adjuvanted vaccine. And late Thursday afternoon, Novavax entered into an agreement with the Serum Institute of India to provide up to 1 billion doses to India and low- and middle-income countries.

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In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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