Dan Skovronsky (Eli Lilly via Facebook)

Don't get too ex­cit­ed about Eli Lil­ly's up­com­ing Alzheimer's read­out just yet, R&D chief cau­tions

Eli Lilly will have results soon from yet another test it’s conducting on the amyloid beta hypothesis in Alzheimer’s. But don’t get your hopes up just yet.

In an unusual move, R&D chief Dan Skovronsky played down expectations for the DIAN-TU trial, which enrolled 490 patients with a genetic mutation that puts them at higher risk for early onset disease. The placebo-controlled study is evaluating their solanezumab and Roche’s gantenerumab, both of which had failed decisively in treating early-stage Alzheimer’s.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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UP­DAT­ED: Biotech's shares rout­ed af­ter the FDA de­mands new tri­al, rais­es safe­ty and end­point is­sues in sur­prise CRL

A small biotech that’s been laboring long and hard on an oral chemo program for metastatic breast cancer was slammed hard on Monday morning, losing more than half of its market cap after revealing that the FDA had issued a surprise CRL with some harsh new hurdles in place.

Athenex $ATNX says that regulators stiff-armed its application for oral paclitaxel and encequidar — a marked setback after winning a priority review earlier that should have signified a more positive regulatory frame of mind. And Athenex was clear that any comeback for this program is going to face a high bar at the FDA.

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Stefan Oschmann, Merck KGaA CEO (Sipa USA via AP Images)

Mer­ck KGaA ear­marks $855M for De­bio­phar­m's pro­grammed cell death pro­mot­ing drug in glob­al li­cens­ing deal

Merck KGaA, primarily known for its CDMO work, is playing with giants in oncology and looking at novel mechanisms of action to compete. Now, the German player is placing a big down payment on a late-stage candidate looking to stop tumor cells’ ability to stave off programmed death.

Merck KGaA will dole out $226 million upfront and up to $855 million in future milestones and royalty payments for exclusive rights to Debiopharm’s IAP candidate xevinapant, which recently emerged from Phase II in first-line, non-metastatic squamous cell carcinoma of the head and neck, the German firm said Monday.

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UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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CEO James Rosen (Artizan)

Pre­ci­sion in­flam­ma­tion drugs? Yale spin­out Ar­ti­zan clinch­es $11M and Bio­haven deal to sin­gle out bad bac­te­ria

As a Yale spinout based in New Haven, Artizan Biosciences was pretty familiar with Biohaven — a successful neuro-focused drug developer and “shining star,” as Artizan CEO James Rosen puts it, in the burgeoning biotech community there.

But when a board director and an investor tried connecting the two, they were in for a surprise.

“Unbeknownst to Artizan, Biohaven had been doing a landscaping exercise surveying microbiome companies with whom to partner for CNS disorders,” Rosen told Endpoints News, “and lo and behold, they found Artizan right in their backyard.”