A US ap­peals court has ruled against John­son & John­son’s use of bank­rupt­cy to deal with mount­ing talc law­suits, de­cid­ing that do­ing so would “cre­ate a le­gal blind spot.”

The Third Cir­cuit Court of Ap­peals re­versed a pre­vi­ous bank­rupt­cy court de­ci­sion on Mon­day, call­ing for the dis­missal of a Chap­ter 11 fil­ing by J&J’s sub­sidiary LTL Man­age­ment.

Faced with more than 38,000 law­suits al­leg­ing its talc-based prod­ucts caused can­cer, J&J spun its talc li­a­bil­i­ties in­to a sep­a­rate com­pa­ny called LTL Man­age­ment back in Oc­to­ber 2021 and filed for bank­rupt­cy, a con­tro­ver­sial move col­lo­qui­al­ly re­ferred to as a “Texas two-step” bank­rupt­cy. Claimants ar­gued that the strat­e­gy is a mis­use of the US bank­rupt­cy code — and on Mon­day, a pan­el of judges agreed.

“For here the debtor was in no fi­nan­cial dis­tress when it sought Chap­ter 11 pro­tec­tion. To ig­nore a par­ent (and grand­par­ent) safe­ty net shield­ing all li­a­bil­i­ty then fore­seen would al­low tun­nel vi­sion to cre­ate a le­gal blind spot. We will not do so,” the court’s opin­ion reads.

J&J’s ba­by pow­der prod­ucts were first sold in 1984, and have been used by hun­dreds of mil­lions of peo­ple. Ques­tions about whether the pow­der con­tained as­bestos first arose back in the 1970s, al­though J&J main­tains that it has “nev­er man­u­fac­tured a prod­uct that con­tained as­bestos.” Up un­til 2010, there were a “small num­ber of iso­lat­ed claims” that the talc prod­ucts caused con­di­tions such as mesothe­lioma and rash­es, ac­cord­ing to court doc­u­ments.

How­ev­er, two ju­ry ver­dicts for plain­tiffs in 2013 and 2016 “ush­ered in a wave of law­suits” al­leg­ing the prod­ucts caused mesothe­lioma and ovar­i­an can­cer. By the time LTL Man­age­ment filed for bank­rupt­cy, there were more than 38,000 ovar­i­an can­cer claims against it.

J&J stopped man­u­fac­tur­ing its talc prod­ucts in the US in 2020, cit­ing de­clin­ing sales caused by “changes in con­sumer habits and fu­eled by mis­in­for­ma­tion around the safe­ty of the prod­uct.” The com­pa­ny said it would change the for­mu­la of its ba­by pow­der prod­ucts this past Au­gust, while main­tain­ing that its talc-based pow­der is “safe, does not con­tain as­bestos and does not cause can­cer.”

An ap­peals court agreed to re­vis­it the bank­rupt­cy case in May. J&J pre­vi­ous­ly promised that all talc prod­ucts would be dis­con­tin­ued glob­al­ly by 2023.

“The Third Cir­cuit’s de­ci­sion is a point-by-point re­jec­tion of J&J’s at­tempt to per­vert the bank­rupt­cy sys­tem and tram­ple the Con­sti­tu­tion­al right to a ju­ry tri­al of all Amer­i­cans harmed by dead­ly prod­ucts,” Jonathan Ruck­de­schel, a lawyer rep­re­sent­ing mesothe­lioma claimants in a class ac­tion suit, said in a state­ment. “The Third Cir­cuit’s de­ci­sion re­in­forces that the Bank­rupt­cy sys­tem is not a tool for the wealthy, no mat­ter how many tens of mil­lions of dol­lars they are will­ing to pay lawyers.”

Mean­while, J&J de­fend­ed its strat­e­gy, claim­ing in a state­ment to End­points News that LTL “ini­ti­at­ed this process in good faith and our ob­jec­tive has al­ways been to eq­ui­tably re­solve claims re­lat­ed to the Com­pa­ny’s cos­met­ic talc lit­i­ga­tion.”

“To­day’s rul­ing does not re­flect the facts es­tab­lished dur­ing the Bank­rupt­cy Court’s tri­al re­gard­ing the ap­pro­pri­ate­ness of LTL’s for­ma­tion and fil­ing, nor the Com­pa­ny’s in­ten­tion to ef­fi­cient­ly re­solve the cos­met­ic talc lit­i­ga­tion for the ben­e­fit of all par­ties, in­clud­ing cur­rent and fu­ture claimants,” the com­pa­ny said, adding that it will chal­lenge the lat­est rul­ing.

If the full pan­el of judges de­ny J&J’s chal­lenge, the com­pa­ny can pe­ti­tion the Supreme Court, ac­cord­ing to a Bloomberg re­port. End­points has re­quest more in­for­ma­tion from J&J, and will up­date the sto­ry ac­cord­ing­ly.

In Oc­to­ber 2021, the phar­ma gi­ant said it had racked up near­ly $1 bil­lion in de­fense costs, and $3.5 bil­lion in pay­ments for set­tle­ments and ver­dicts. J&J ar­gued those costs were un­ten­able, and that a Chap­ter 11 was need­ed to “ap­pro­pri­ate­ly as­sess, re­solve, and ad­min­is­ter these claims in an ef­fi­cient and eq­ui­table man­ner.”

John­son & John­son’s stock $JNJ was down more than 3.3% on Mon­day af­ter­noon, trad­ing at around $162.61 per share.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”