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?

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.