Peer Re­view: For­mer FDA Com­mish Califf will split his time be­tween Ver­i­ly and Duke

→ Af­ter a lit­tle over a year and a half at Al­pha­bet’s Ver­i­ly, neu­ro­sci­en­tist Dr. Thomas In­sel is join­ing the mys­te­ri­ous com­pa­ny’s ex­o­dus of tal­ent and call­ing it quits. In­sel ran the Na­tion­al In­sti­tute of Men­tal Health pri­or to his gig at Ver­i­ly. These days you can find him as the pres­i­dent and co-founder at a start­up called Mind­strong Health, which “has de­vel­oped and patent­ed a bio­mark­er pan­el that mea­sures brain func­tion from in­ter­ac­tion pat­terns cap­tured pas­sive­ly and con­tin­u­ous­ly from hu­man-com­put­er in­ter­faces found in ubiq­ui­tous mo­bile tech­nol­o­gy.”

Robert Califf

En­ter­ing the Ver­i­ly realm is Robert Califf. The ex-FDA com­mis­sion­er pre­vi­ous­ly worked with Ver­i­ly head An­dew Con­rad be­fore to head­ing up the agency. He’s al­so back at Duke Uni­ver­si­ty. “Af­ter con­clud­ing what has been an amaz­ing ex­pe­ri­ence as FDA Com­mis­sion­er, I’m ex­cit­ed to turn to a new ca­reer with Ver­i­ly and Duke Uni­ver­si­ty,” says Califf in his Ver­i­ly blog post.

→  Al­most ex­act­ly four years af­ter be­ing named per­ma­nent chief sci­en­tif­ic of­fi­cer at Bio­gen, Spy­ros Ar­ta­va­nis-Tsakonas has qui­et­ly left the com­pa­ny. The cell bi­ol­o­gy spe­cial­ist has been a pro­fes­sor at Har­vard Med­ical School since 1999. And now he’s head­ed back with fund­ing from Bio­gen on new re­search in­to neu­rode­gen­er­a­tive dis­eases. The big biotech gets an op­tion on li­cens­ing new tech from his lab in ex­change for the fund­ing.

→  For­mer Sarep­ta CEO Chris Garabe­di­an has won $15 mil­lion from some loy­al back­ers at Per­cep­tive Ad­vi­sors to es­tab­lish Xon­toge­ny, which promis­es to guide biotech star­tups through the first crit­i­cal stage of de­vel­op­ment lead­ing to proof-of-con­cept da­ta. Garabe­di­an is run­ning the show and he’s now re­cruit­ing a team.

Patrick Am­stutz has made the jump from in­ter­im CEO to the re­al deal. Am­stutz helmed Mol­e­c­u­lar Part­ners af­ter Chris­t­ian Zahn left the job late last year.

Ox­itec CEO Ha­dyn Par­ry is join­ing the moth­er ship. Par­ry has been bumped up to VP of cor­po­rate de­vel­op­ment, Eu­rope, the Mid­dle East, and Africa for In­trex­on. Look for Mark Carnegie-Brown to be in charge of Ox­itec as the new CEO.

→  Is­rael’s Al­co­bra said that CEO Yaron Daniely is step­ping down to head up the tech trans­fer arm at He­brew Uni­ver­si­ty.

Cy­tomX is shuf­fling the deck, with Bob Goetz ex­it­ing the CFO po­si­tion of the South San Fran­cis­co, CA-based biotech to “pur­sue new op­por­tu­ni­ties.” De­ban­jan Ray is now the new CFO and head of cor­po­rate de­vel­op­ment. “De­ban­jan has been in­stru­men­tal to Cy­tomX’s busi­ness suc­cess, in­clud­ing struc­tur­ing and ex­e­cut­ing col­lab­o­ra­tions that have re­sult­ed in more than $300 mil­lion in up­front and mile­stone pay­ments to date and to­tal po­ten­tial deal val­ue in ex­cess of $5 bil­lion,” said CEO Sean Mc­Carthy.

→ Ac­tini­um CEO Kaushik J. Dave and Chief Tech­nol­o­gy Of­fi­cer Dra­gan Ci­cic have both re­signed from the com­pa­ny

 

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.