Isao Teshirogi, Shionogi president and CEO (Kiyoshi Ota/Bloomberg via Getty Images)

PhII Alzheimer's da­ta loom­ing, Sh­iono­gi spend­ing up to $500M on a buy­out in­volv­ing one of the tough­est bets in biotech

Sh­iono­gi moved a cou­ple of months ago to get in tight with a low-pro­file biotech called Tetra Ther­a­peu­tics in Grand Rapids, MI. And what­ev­er they learned about their 2 Phase II stud­ies in Alzheimer’s and Frag­ile X syn­drome per­suad­ed the phar­ma play­er to ante up to $500 mil­lion more on a buy­out.

Tues­day morn­ing, Sh­iono­gi an­nounced that it is buy­ing Tetra out­right as the biotech nav­i­gates the fi­nal stretch­es on 2 mid-stage tri­als.

Both in­di­ca­tions are in the ex­treme high-risk cat­e­go­ry, with Tetra build­ing on a se­ries of grants to test its own ap­proach on pro­tect­ing the neu­ronal con­nec­tions that play a ma­jor role in cog­ni­tion and mem­o­ry.

Their lead drug is BPN14770, which tar­gets an en­zyme that is sup­posed to mod­u­late PDE4D. Sh­iono­gi orig­i­nal­ly got in­volved with Tetra back in 2018, when ex­ecs signed up li­cens­ing rights in Asia.

In March Sh­iono­gi fol­lowed up with a deal to ex­pand its stake in Tetra to 50%, ink­ing an op­tion on the buy­out based on the read­out for the Phase II PI­CAS­SO AD study in Alzheimer’s.

The an­nounce­ment, though, is short on fi­nan­cial de­tails. That’s not too sur­pris­ing, as Sh­iono­gi is ex­pand­ing in­to a field not­ed for 10 years of fail­ure and con­tro­ver­sy. Alzheimer’s has re­sist­ed just about every­thing thrown against it, with no suc­cess in mod­u­lat­ing the dis­ease it­self. Bio­gen has at­tract­ed equal parts of praise and crit­i­cism for its own at­tempt at get­ting a drug across the fin­ish line.

We can now wait for near-term proof-of-con­cept da­ta from Sh­iono­gi, which is keep­ing the lit­tle biotech as a whol­ly-owned sub­sidiary.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.

Look­ing to build in red-hot vi­ral vec­tor space, Ther­mo Fish­er inks $878M deal for Bel­gian man­u­fac­tur­er's 2 plants

Between Covid-19 vaccines and gene therapies, the contract manufacturing market for viral vector tech has grown at a rapid clip. Thermo Fisher Scientific, already one of the biggest CDMOs on the block, has now made a move to buoy its EU footprint in that field.

Thermo Fisher will pay $878 million to acquire Henogen SA, Novasep’s viral vector manufacturing business, which comprises two Belgian locations in Seneffe and Gosselies that offer over 75,000 square feet of clinical and commercial manufacturing capacity, the Massachusetts company said Friday.

Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

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UP­DAT­ED: Am­gen tops cost watch­dog's price gougers list based on 'un­sup­port­ed' in­creas­es for En­brel with­out mean­ing­ful da­ta

In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.

Price increases for some of pharma’s most popular drugs have long been a focus of consumer ire, but the industry has argued those increases are routine and meant to cover the cost of R&D innovation. Without meaningful guidance at the state or federal level, ICER looked to connect how much a drug had progressed in the clinic compared with its increase in both wholesale and net price in 2019.

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