Mi­crosoft, Google back DNAnexus' Big Da­ta work with $58M; No­var­tis, Temasek back $50M round for Pear’s med apps

→ Big Da­ta is worth Big Mon­ey. DNAnexus has grabbed a $58 mil­lion fi­nanc­ing round led by new in­vestor Fore­site Cap­i­tal with help from Mi­crosoft, GV (for­mer­ly Google Ven­tures), TPG Biotech, WuXi NextCODE, Clare­mont Creek Ven­tures, and Mid­Cap Fi­nan­cial. The com­pa­ny touts a plat­form tech en­abling clients to glean new in­sights from large ge­nom­ic and bio­med­ical datasets. “As the vol­ume of bio­med­ical in­for­ma­tion con­tin­ues to in­crease, the DNAnexus Plat­form and up­com­ing prod­uct re­leas­es cat­alyze col­lab­o­ra­tion, da­ta shar­ing and ma­chine learn­ing on which the de­vel­op­ment of pre­ci­sion med­i­cine de­pends. Fore­site Cap­i­tal is pleased to lead this new fi­nanc­ing round,” said Jim Tanan­baum, founder and CEO of Fore­site Cap­i­tal.

→ A few months af­ter Pear Ther­a­peu­tics scored an FDA ap­proval for its mo­bile app to help pa­tients deal with sub­stance abuse, the biotech has round­ed up a $50 mil­lion ven­ture round to keep rolling on a field it calls dig­i­tal med­i­cine. Pear’s new apps will fo­cus on fields like schiz­o­phre­nia, PTSD, anx­i­ety and de­pres­sion with tech­nol­o­gy aimed at bet­ter com­pli­ance and coach­ing.

→ The FDA has ac­cept­ed Achao­gen’s ap­pli­ca­tion for pla­zomicin as a new ther­a­py for com­pli­cat­ed uri­nary tract in­fec­tions, hand­ing the biotech a pri­or­i­ty re­view. The PDU­FA date is June 25 and Achao­gen ex­pects to have its Eu­ro­pean ap­pli­ca­tion ready lat­er in the year. You can al­so ex­pect an ad­vi­so­ry com­mit­tee hear­ing on the ap­pli­ca­tion.

→ The pen­ny stock biotech Pro­tal­ix $PLX ran out a pos­i­tive, ear­ly stage snap­shot of the da­ta they’re see­ing in a mid-stage study of OPRX-106 (oral an­ti-TNF) in pa­tients with ul­cer­a­tive col­i­tis. Re­searchers for the Is­raeli com­pa­ny tout­ed a 36% re­mis­sion rate at 8 weeks in 14 pa­tients, which helped to light­ly buoy shares this morn­ing.

→ A bad­ly bat­tered Sy­ros $SYRS has lined up a sup­ply of J&J’s Darza­lex for added Phase II co­horts us­ing a com­bo with SY-1425 on ge­nom­i­cal­ly de­fined sub­sets of pa­tients with acute myeloid leukemia and myelodys­plas­tic syn­drome.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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News brief­ing: Eli Lil­ly com­pletes $1B+ Pre­vail buy­out; El­zon­ris ap­proved in Eu­rope for adults

Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.

The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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