Af­ter gain­ing key sup­port for Cel­gene buy­out, Bris­tol-My­ers CEO Caforio emerges as like­ly win­ner in loom­ing share­hold­er vote

It’s like­ly all over but for the share­hold­er vote and reg­u­la­to­ry ap­provals now.

Af­ter Bris­tol-My­ers Squibb’s largest share­hold­er star­tled Wall Street with its out­right op­po­si­tion to the big Cel­gene buy­out, the ac­tivists at Star­board Val­ue helped make it in­ter­est­ing with their own in­tense — but short-lived — cam­paign to squelch the deal. 

On Fri­day, though, the flag car­ri­er for all the doubters among the share­hold­ers top­pled their stan­dard and walked away, drop­ping their proxy fight af­ter 2 key ad­vi­so­ry firms — ISS and Glass Lewis — came out in sup­port of the M&A deal.

Al­ready a long shot ef­fort to de­rail the buy­out, Star­board Val­ue wasn’t in­ter­est­ed in con­tin­u­ing what would have been a most­ly quixot­ic ef­fort. The vote is slat­ed for April 12, and there’s no ques­tion that af­ter a brief scare in the ex­ec­u­tive suite, CEO Gio­van­ni Caforio has emerged as the dom­i­nant fa­vorite to win a share­hold­er en­dorse­ment, doubts and all.

The FTC did spot­light one po­ten­tial hitch, point­ing to an over­lap on pso­ri­a­sis that aroused some reg­u­la­to­ry dis­con­tent. That kind of ob­jec­tion can typ­i­cal­ly be han­dled with a quick as­set sale.

Here’s the state­ment from Star­board Val­ue:

We are ex­treme­ly dis­ap­point­ed by the con­clu­sions reached by the proxy vot­ing ad­vi­so­ry firms, In­sti­tu­tion­al Share­hold­er Ser­vices (“ISS”) and Glass, Lewis & Co., LLC (“Glass Lewis”). We con­tin­ue to feel strong­ly that the pro­posed trans­ac­tion be­tween Bris­tol-My­ers and Cel­gene Cor­po­ra­tion (“Cel­gene”) is a bad deal for share­hold­ers that car­ries too much risk and there­fore in­tend to vote our shares against the deal at the up­com­ing spe­cial meet­ing. We al­so rec­og­nize that, de­spite the sub­stan­tial swell of sup­port against this trans­ac­tion, it is ex­treme­ly dif­fi­cult for share­hold­ers to pre­vail with­out a sup­port­ive rec­om­men­da­tion from ISS and Glass Lewis to vote against the trans­ac­tion. There­fore, Star­board has de­cid­ed to with­draw its proxy so­lic­i­ta­tion to vote against the Cel­gene trans­ac­tion. How­ev­er, if share­hold­ers want to pro­tect and save Bris­tol-My­ers, they can still vote against the Com­pa­ny’s pro­posed ac­qui­si­tion of Cel­gene on the Com­pa­ny’s white proxy card.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Jim Tananbaum, Foresite

Fore­site re­turns to the SPAC well, as in­vestors won­der how long the run can last

Six months after launching his first biotech SPAC, Foresite’s Jim Tananbaum has started a second. On Tuesday, the longtime life science investor filed to raise $100 million by selling 10 million shares of the blank check company FS development II.

It’s a quick return to Wall Street for Foresite, although other firms have moved quicker. Perceptive Advisors raised a $130 million SPAC in June and were back before the end of July to raise another $125 million. By that point, the firm was evidently nearing a deal for the June SPAC, which would announce a half-billion-dollar merger with Cerevel Therapeutics on July 30.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.