J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

Af­ter con­tro­ver­sial­ly spin­ning out its talc li­a­bil­i­ties and fil­ing for bank­rupt­cy in an at­tempt to set­tle 38,000 law­suits, John­son & John­son is now chang­ing up the for­mu­la for its ba­by pow­der prod­ucts.

J&J is be­gin­ning the tran­si­tion to an all corn­starch-based ba­by pow­der port­fo­lio, the phar­ma gi­ant an­nounced on Thurs­day — just months af­ter a fed­er­al judge ruled in fa­vor of its “Texas two-step” bank­rupt­cy to set­tle al­le­ga­tions that its talc prod­ucts con­tained as­bestos and caused can­cer. An ap­peals court has since agreed to re­vis­it that case.

De­spite chang­ing the in­gre­di­ents, J&J main­tains that its talc-based ba­by pow­der is “safe, does not con­tain as­bestos and does not cause can­cer.” The com­pa­ny stopped man­u­fac­tur­ing its talc prod­ucts in the US back in 2020, at­tribut­ing the de­ci­sion not to safe­ty con­cerns, but to de­clin­ing sales caused by “changes in con­sumer habits and fu­eled by mis­in­for­ma­tion around the safe­ty of the prod­uct.”

Now, J&J says the talc prod­ucts will be dis­con­tin­ued glob­al­ly by 2023.

“Our corn­starch-based JOHN­SON’S® Ba­by Pow­der is al­ready avail­able in coun­tries around the world. The pro­duc­tion of talc-based pow­der will wind down by Q1 2023, and ex­ist­ing in­ven­to­ry will con­tin­ue to be sold by re­tail­ers around the world as sup­ply ca­pac­i­ty for an all-corn­starch port­fo­lio is in­creased,” a spokesper­son told End­points News in an email.

The com­pa­ny has racked up tens of thou­sands of law­suits over its talc prod­ucts, on­ly a hand­ful of which have made it to tri­al and been re­solved in the last decade. In an at­tempt to dig it­self out, J&J spun the li­a­bil­i­ties in­to a sep­a­rate com­pa­ny, LTL Man­age­ment, in Oc­to­ber and filed for a Chap­ter 11 — a move col­lo­qui­al­ly known as a “Texas two-step” bank­rupt­cy.

Crit­ics, in­clud­ing a group of law pro­fes­sors who filed a “friend of the court” brief, called the move a “di­rect at­tack on the fun­da­men­tal in­tegri­ty of the Chap­ter 11 sys­tem.”

Mean­while, J&J ar­gued that it had ac­cu­mu­lat­ed “un­ten­able” costs, in­clud­ing near­ly $1 bil­lion in de­fense costs and $3.5 bil­lion in pay­ments for set­tle­ments and ver­dicts. Dur­ing the tri­al, it claimed that start­ing in Jan­u­ary 2020, it had been served on av­er­age with one or more ovar­i­an can­cer com­plaints every hour of every day.

In al­low­ing the bank­rupt­cy to go forth, Judge Michael Ka­plan of New Jer­sey not­ed that “many of these can­cer vic­tims will not live to see their cas­es through the tri­al and ap­pel­late sys­tems, but cer­tain­ly de­serve the com­fort in know­ing that their fam­i­lies’ fi­nan­cial needs will be ad­dressed time­ly.”

How­ev­er, an ap­peals court agreed to re­vis­it Ka­plan’s de­ci­sion back in May. And even if it holds up, the bank­rupt­cy fil­ing can’t stop oth­er cas­es, in­clud­ing a pro­posed class-ac­tion law­suit al­leg­ing the com­pa­ny hid ev­i­dence that work­ers may have been ex­posed to as­bestos from the talc op­er­a­tions.

J&J said in a state­ment that its de­ci­sion to switch to corn­starch was “part of a world­wide port­fo­lio as­sess­ment.”

“We con­tin­u­ous­ly eval­u­ate and op­ti­mize our port­fo­lio to best po­si­tion the busi­ness for long-term growth. This tran­si­tion will help sim­pli­fy our prod­uct of­fer­ings, de­liv­er sus­tain­able in­no­va­tion, and meet the needs of our con­sumers, cus­tomers and evolv­ing glob­al trends,” it said.

The Of­fi­cial Com­mit­tee of Talc Claimants (TCC) said in an emailed state­ment on Fri­day that they will con­tin­ue to fight in court:

J&J has known for decades that its talc-based prod­ucts could cause dead­ly can­cers,” the com­mit­tee said. “While J&J is fi­nal­ly tak­ing steps to re­duce the num­ber of in­di­vid­u­als at risk, the TCC con­tin­ues fight­ing for jus­tice for the vic­tims who were need­less­ly ex­posed to these dan­ger­ous cos­met­ic prod­ucts and con­tin­ue to suf­fer and die as a re­sult of J&J’s con­duct.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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