J&J's Alex Gorsky re­vers­es course and jumps ship — just as Trump scut­tles top CEO groups

Alex Gorsky

One day af­ter J&J CEO Alex Gorsky pub­licly com­mit­ted to stay­ing on Pres­i­dent Don­ald Trump’s man­u­fac­tur­ing coun­cil, he abrupt­ly re­versed course — just as a sud­den ex­o­dus of ex­ec­u­tives forced the pres­i­dent’s hand and pushed him to dis­band two promi­nent ad­vi­so­ry com­mit­tees.

J&J an­nounced Wednes­day af­ter­noon that the pres­i­dent’s po­si­tion on the dead­ly Char­lottesville con­fronta­tion was un­ac­cept­able, adding that Gorsky was re­sign­ing with im­me­di­ate ef­fect. But as J&J was putting out their state­ment, Trump is­sued his on Twit­ter.

Gorsky had no soon­er told the world on Tues­day that he wasn’t fol­low­ing Ken Fra­zier’s de­ci­sion to re­sign from the man­u­fac­tur­ing coun­cil than Trump called a press con­fer­ence and ve­he­ment­ly in­sist­ed that both sides of the vi­o­lent and dead­ly con­fronta­tion in Char­lottesville, VA — the neo-Nazis, KKK and oth­ers as well as the pro­test­ers who came out to op­pose their demon­stra­tion — were equal­ly to blame.

Equat­ing the two, while al­so not­ing that the right-wing ex­trem­ists had a le­gal per­mit for their demon­stra­tion, led to a po­lit­i­cal earth­quake in Wash­ing­ton DC which is still rum­bling through the capi­tol.

Gorsky wasn’t en­dors­ing the pres­i­dent’s po­si­tion when he an­nounced his plans to stay on the man­u­fac­tur­ing coun­cil. That de­ci­sion to stay on, he said in a pre­pared state­ment, was in­flu­enced by his de­sire to main­tain the com­pa­ny’s eth­i­cal cre­do with­in a se­nior White House cir­cle.

Trump’s de­ci­sion to end the eco­nom­ic ad­vi­so­ry group came on­ly af­ter the CEOs in­volved got to­geth­er and vot­ed to dis­band.

The sud­den up­heaval could well com­pli­cate things for bio­phar­ma at a tick­lish time.

J&J has al­so been lob­by­ing, along with the rest of the in­dus­try, for tax re­form leg­is­la­tion that would low­er rates on repa­tri­at­ing mon­ey from over­seas ac­counts. And no one in a top lead­er­ship po­si­tion at any of the phar­ma com­pa­nies would have en­joyed Trump’s re­cent move to start call­ing out the in­dus­try for high drug prices or their over­seas man­u­fac­tur­ing op­er­a­tions, which resur­faced af­ter Ken Fra­zier got the ball rolling on Mon­day as po­lit­i­cal sup­port for the pres­i­dent crum­bled in ex­ec­u­tive suites from coast-to-coast.

Who can rep­re­sent those in­ter­ests ef­fec­tive­ly in the White House now that some of the most promi­nent ex­ecs in the busi­ness won’t come with­in a mile of the White House?

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.