Alex Gorsky, AP Images

J&J joins Bris­tol My­ers Squibb with $100M com­mit­ment to di­ver­si­ty ef­forts

A day af­ter the Bris­tol My­ers Squibb Foun­da­tion launched a $100 mil­lion pro­gram to di­ver­si­fy clin­i­cal tri­als, John­son & John­son says it’s al­so com­mit­ting $100 mil­lion to health eq­ui­ty ef­forts.

“There is an ur­gent need to take on the in­equities root­ed in sys­temic racism that threat­en health in com­mu­ni­ties of col­or across the Unit­ed States,” CEO Alex Gorsky said in a state­ment. “That’s why John­son & John­son is fo­cus­ing its ef­forts and com­mit­ting $100 mil­lion to ad­dress racial and so­cial in­jus­tice as the crit­i­cal pub­lic health is­sue that it is.”

J&J ini­tial­ly made a $10 mil­lion com­mit­ment back in May, short­ly af­ter George Floyd’s death. Then over the next sev­er­al months, it worked to cre­ate a “broad­er and more com­pre­hen­sive plan,” which in­volved in­creas­ing their com­mit­ment to $100 mil­lion over the next five years. In to­tal, the com­mit­ment makes up about 0.1% of the com­pa­ny’s $82.1 bil­lion rev­enue in 2019.

The mon­ey will go to a va­ri­ety of pro­grams and part­ner­ships, from Covid-19 test­ing ini­tia­tives to di­ver­si­ty and in­clu­sion ef­forts with­in the com­pa­ny.

“The qual­i­ty of your health­care should not be de­ter­mined by your race and eth­nic­i­ty,” Gorsky said.

Amid the pan­dem­ic, Black Amer­i­cans have con­tract­ed Covid-19 at a rate 2.6 times high­er than white Amer­i­cans, and they’ve died at a 2.1 times high­er rate. In­dige­nous and Lat­inx pop­u­la­tions are both at a 2.8 times high­er risk of in­fec­tion, ac­cord­ing to the CDC. Part of J&J’s ef­fort in­cludes di­ver­si­fy­ing clin­i­cal tri­als, in­clud­ing its own Covid-19 vac­cine tri­als.

“Built on a lega­cy of pur­pose-dri­ven ac­tions and a com­mit­ment to di­ver­si­ty and in­clu­sion, the Com­pa­ny aims to achieve rep­re­sen­ta­tion of pop­u­la­tions that have been dis­pro­por­tion­ate­ly im­pact­ed by the pan­dem­ic in the im­ple­men­ta­tion of its Covid-19 Phase III tri­al pro­gram,” the com­pa­ny said in a state­ment.

The phar­ma al­so says it’s fund­ing mo­bile vans to sup­port Covid-19 test­ing in high-need ar­eas, start­ing with De­troit and New Or­leans. It promised to part­ner with com­mu­ni­ty clin­ics and fed­er­al­ly-qual­i­fied health cen­ters to im­prove tech­nol­o­gy and mo­bile health op­tions, and with the non­prof­it Ex­ec­u­tive Lead­er­ship Coun­cil to pro­vide schol­ar­ships to Black stu­dents in­ter­est­ed in the STEM, busi­ness or health fields. Oth­er part­ner­ships will ad­dress the dis­pro­por­tion­ate health im­pact of cli­mate change on com­mu­ni­ties of col­or.

Tak­ing an in­ward look, J&J aims to sig­nif­i­cant­ly bol­ster di­ver­si­ty in man­age­ment roles over the next five years, and re­work HR process­es “to op­ti­mize how it ac­cess­es, hires, and de­vel­ops tal­ent.”

Yes­ter­day, the Bris­tol My­ers Squibb Foun­da­tion tagged $100 mil­lion from a pre­vi­ous­ly an­nounced $300 mil­lion com­mit­ment for a new pro­gram to tack­le the lack of di­ver­si­ty in clin­i­cal tri­als. The pro­gram in­cludes a train­ing com­po­nent for 250 new clin­i­cal in­ves­ti­ga­tors, fel­low­ships for 250 mi­nor­i­ty med­ical stu­dents, and an in­fra­struc­ture fund to help in­ves­ti­ga­tors build new clin­i­cal tri­al sites.

The new sites will like­ly go “in clin­i­cal tri­al deserts where … the dis­ease bur­den is high but clin­i­cal tri­als don’t ex­ist in those sites, or even look to build­ing out in ur­ban cen­ters through safe­ty net hos­pi­tals and oth­ers,” John Da­mon­ti, pres­i­dent of the Bris­tol My­ers Squibb Foun­da­tion, told End­points News.

Back in Ju­ly, John­son & John­son re­moved two lines of skin-light­en­ing prod­ucts pop­u­lar in Asia, as com­pa­nies faced crit­i­cism that such prod­ucts are racist, ac­cord­ing to an NPR re­port. “Con­ver­sa­tions over the past few weeks high­light­ed that some prod­uct names or claims on our Neu­tro­ge­na and Clean & Clear dark spot re­duc­er prod­ucts rep­re­sent fair­ness or white as bet­ter than your own unique skin tone,” the com­pa­ny told NPR. “This was nev­er our in­ten­tion – healthy skin is beau­ti­ful skin.”

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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

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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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

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.