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?

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.