Boris John­son pledges £250M to spur AI adop­tion in NHS; SQZ scoops CFO Teri Lox­am from Mer­ck

→ Last year, for­mer UK health sec­re­tary Je­re­my Hunt com­mis­sioned Cal­i­for­nia-based Er­ic Topol, a car­di­ol­o­gist, au­thor and dig­i­tal med­i­cine re­searcher, to car­ry out an in­de­pen­dent re­view in­to the dig­i­tal train­ing needs of NHS staff. The re­port was re­leased in Feb­ru­ary, de­tail­ing the promise of ge­nomics, ar­ti­fi­cial in­tel­li­gence, ro­bot­ics and dig­i­tal med­i­cine in the pre­ven­tion, man­age­ment and treat­ment of dis­ease. On Thurs­day, the UK health de­part­ment — un­der new Prime Min­is­ter Boris John­son — un­veiled a £250 mil­lion in­vest­ment in Al, which is al­ready be­ing de­vel­oped in some hos­pi­tals, suc­cess­ful­ly pre­dict­ing can­cer sur­vival rates and cut­ting the num­ber of missed ap­point­ments.

→ Cell ther­a­py play­er SQZ Biotech has wooed se­nior Mer­ck ex­ec Teri Lox­am to be­come its CFO. The phar­ma gi­ant said that Lox­am, who’s been man­ag­ing in­vestor re­la­tions and glob­al com­mu­ni­ca­tions, “will be missed per­son­al­ly and pro­fes­sion­al­ly.” Pe­ter Dan­nen­baum has been pro­mot­ed to fill her shoes.

Agenus has reaped an­oth­er $7.5 mil­lion from its part­ner­ship with Gilead, bag­ging the sec­ond mile­stone pay­ment since Gilead put down $150 mil­lion on the deal ta­ble late last year. the IND clear­ance of AGEN2373, a CD137 ag­o­nist and one of up to five im­muno-on­col­o­gy projects that its big biotech part­ner signed up for. It’s still just a taste of the po­ten­tial for­tunes to come, though: If all goes smooth­ly, Agenus — which had been strug­gling for cash pri­or to the deal — is in for $1.7 bil­lion to­tal.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves the third NMOSD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,800+ biopharma pros reading Endpoints daily — and it's free.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.