Rob Brainin (Genuity)

Meet the lat­est ge­nom­ic da­ta com­pa­ny — aka WuXi NextCODE with­out the Chi­na op­er­a­tions

Just five years af­ter WuXi en­gi­neered a deal to merge its genome cen­ter with NextCODE Health, the WuXi NextCODE brand is be­com­ing his­to­ry as the com­pa­ny cuts off the Chi­nese op­er­a­tions and fo­cus­es on the US, Ice­land and Ire­land.

The new name, Ge­nu­ity Sci­ence, eras­es all ref­er­ences to WuXi NextCODE’s sto­ried his­to­ry. The US and Ice­land of­fices of the ge­nomics com­pa­ny were spun out of de­CODE Ge­net­ics af­ter it got ac­quired by Am­gen — with its own twists and turns. Its $400 mil­lion ex­pan­sion in­to Ire­land took place in late 2018, com­plete with the ac­qui­si­tion of Ge­nomics Med­i­cine Ire­land.

Where­as WuXi NextCODE had moved its head­quar­ters from Shang­hai to Cam­bridge over two years, Ge­nu­ity will shift its com­mand cen­ter to Boston.

Ac­cord­ing to the com­pa­ny, the rea­son for cut­ting off its Chi­na ties is pure­ly le­gal. Chi­na tight­ened its Hu­man Ge­net­ics Re­source Reg­u­la­tion and oth­er rules in mid-2019, and NextCODE was among many com­pa­nies that were des­ig­nat­ed as for­eign en­ti­ties — erect­ing se­ri­ous con­straints to their work and pos­si­bil­i­ty for growth overnight.

The ca­pa­bil­i­ties they had in Shang­hai were “val­ued by a num­ber of our in­ter­na­tion­al cus­tomers,” said Rob Brain­in, whose cards now say CEO of Ge­nu­ity.

Now that it’s gone, they have poured more re­sources in both Dublin and Woburn, MA, to do some of the things their Chi­nese col­leagues used to han­dle.

Be­tween the three re­main­ing sites, Ge­nu­ity has more than 200 em­ploy­ees sourc­ing, con­sol­i­dat­ing and an­a­lyz­ing ge­nom­ic da­ta for part­ners. Re­cent­ly, they’ve be­gun sup­port­ing Irish re­search in­sti­tu­tions in se­quenc­ing the genomes of Covid-19 pa­tients.

Of­fi­cial sep­a­ra­tion from the Shang­hai of­fice is slat­ed for lat­er this year, al­though Ge­nu­ity is al­ready con­sid­er­ing what to do with it.

De­spite the shake­up, its in­vestor base ac­tu­al­ly re­mains the same, fea­tur­ing some mar­quee names such as Temasek, ARCH and Se­quoia Cap­i­tal. None of them, Brain­in felt com­pelled to add, will have ac­cess to sen­si­tive in­for­ma­tion or in­ter­nal da­ta.

As he clar­i­fied in an email:

WuXi NextCODE is not owned by WuXi AppTec or oth­er WuXi com­pa­nies. Since 2017, WuXi NextCODE has been op­er­at­ing as an in­de­pen­dent pri­vate com­pa­ny with for­mer WuXi Phar­maT­e­ch share­hold­ers serv­ing among the com­pa­ny’s many in­vestors.

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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Pascal Soriot (AP Images)

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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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

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)

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.