Re­Vi­ral taps Seth Het­her­ing­ton to guide up­com­ing PhI­Ia; In­cyte, Aquinox ex­ecs move to AI shop No­table Labs

→ Ox­ford, Eng­land-based vac­cine de­vel­op­er Emergex has re­cruit­ed Big Phar­ma vet Athana­sios Pa­padopou­los to be its CMO. Jump­ing from Sanofi — where he helped de­vel­op the ground­break­ing but ill-fat­ed Deng­vax­ia — Pa­padopou­los in­her­its a uni­ver­sal Fla­vivirus vac­cine can­di­date now poised for Phase I in H2 2019 and a new R&D fa­cil­i­ty for Emergex’s syn­thet­ic vac­cines.

Re­Vi­ral has tapped Seth Het­her­ing­ton to steer its lead RSV can­di­date in­to pe­di­atric Phase IIa tri­als. As CMO (a role he re­cent­ly held for sev­en years at Geno­cea Bio­sciences), Het­her­ing­ton will lead the biotech in nav­i­gat­ing a field full of nasty sur­pris­es, though Re­Vi­ral has rea­sons to be con­fi­dent giv­en pos­i­tive re­sults in a pre­vi­ous PhI­Ia. He will be based in the British com­pa­ny’s US of­fice.

→ On a quest to prove its au­to­mat­ed lab­o­ra­to­ry can lead to faster, cheap­er de­vel­op­ment of drugs, AI start­up No­table Labs has re­cruit­ed two in­dus­try vets to steer the can­cer drug pro­gram it’s just launched. Hi­roo­mi Ta­da, a re­cent In­cyte ex­ec and Glax­o­SmithK­line alum, comes on as chief med­ical of­fi­cer while Lloyd Macken­zie will as­sume the ti­tle chief de­vel­op­ment of­fi­cer af­ter run­ning R&D at Aquinox for 11 years.

Atre­ca has brought in Herb Cross to re­place re­tir­ing CFO Su­san Berland, who will re­main a con­sul­tant to the com­pa­ny. This will be Cross’ fifth time in the role, hav­ing re­cent­ly led Ar­mo Bio­sciences through an IPO and ul­ti­mate­ly a sale to Eli Lil­ly

→ Af­ter spend­ing six years scout­ing col­lab­o­ra­tions for PCI Biotech’s pho­to­chem­i­cal in­ter­nal­iza­tion tech plat­form for can­cer, Gaël L’Hévéder is mov­ing on­to a new stint. His res­ig­na­tion will be ef­fec­tive at the end of the month. A sea­soned BD ex­ec, L’Hévéder’s re­sume fea­tures stints at Roche and Sanofi as well as a short time run­ning his own start­up in Switzer­land.

→ Two years af­ter bring­ing out the bud­get ax and shak­ing up its glob­al R&D group, Dai­ichi Sankyo is re­vamp­ing the lead­er­ship of its re­search arm and shift­ing the cen­ter of grav­i­ty to the US. Who’s out: Glenn Gorm­ley, who took the R&D reins at Dai­ichi Sankyo in 2011 af­ter a 20-year run at three big phar­ma groups: Mer­ck, As­traZeneca and No­var­tis. He’ll stay on, though, as chair­man of the board and spe­cial ad­vis­er to glob­al CEO Jo­ji Nakaya­ma. Who’s in: Ju­nichi Ko­ga, who’s get­ting a pro­mo­tion from head of the R&D group in Japan to the over­all chief’s po­si­tion, based in New Jer­sey.

→ Fol­low­ing a rough few weeks, the re­volv­ing door at the ex­ec­u­tive suite to Im­munomedics $IM­MU is turn­ing once more. CEO Michael Pehl has de­cid­ed to leave for per­son­al rea­sons. His abrupt ex­it af­ter 15 months on the job comes a lit­tle more than a month af­ter the FDA hand­ed the com­pa­ny a CRL for its ap­pli­ca­tion to mar­ket the an­ti­body drug con­ju­gate IM­MU-132, or sac­i­tuzum­ab govite­can. Pehl was brought in to end the long-run­ning dra­ma over the drug and the com­pa­ny, which had been tak­en over by the crew led by ven­Bio’s Be­hzad Ag­haz­adeh.

Amy Mc­K­ee, one of Richard Paz­dur’s close al­lies in build­ing out the On­col­o­gy Cen­ter of Ex­cel­lence at the FDA, has left the agency to be­come VP of reg­u­la­to­ry con­sult­ing ser­vices at Parex­el. At the CRO, she joins a nascent on­col­o­gy ini­tia­tive ded­i­cat­ed to con­nect­ing dif­fer­ent busi­ness units to work up de­vel­op­ment plans, guid­ing com­pa­nies in nav­i­gat­ing a reg­u­la­to­ry land­scape she helped shape.

→ Mit­subishi Tan­abe’s US unit has el­e­vat­ed Sam Shum to its lead­er­ship team as VP of op­er­a­tions and strat­e­gy, trust­ing him with every­thing from fi­nance, busi­ness process and pub­lic af­fairs to sup­ply chain and qual­i­ty as­sur­ance. That marks a sig­nif­i­cant ex­pan­sion in re­spon­si­bil­i­ties from Shum’s pre­vi­ous role as se­nior di­rec­tor of fi­nanc­ing plan­ning and an­a­lyt­ics. He fills the shoes of Ar­mand Famigli­et­ti, who is be­com­ing an ad­vis­er to the com­pa­ny.

Todd Wood is the new chief com­mer­cial of­fi­cer at DermTech, tasked with lin­ing up re­im­burse­ments for its pre­ci­sion di­ag­nos­tic prod­ucts for skin can­cers, in­flam­ma­to­ry dis­eases and oth­er der­ma­to­log­i­cal in­di­ca­tions.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.