With law­suits pil­ing up al­leg­ing its talc ba­by pow­der prod­ucts are un­safe, J&J has tak­en the con­tro­ver­sial step of spin­ning out its re­lat­ed li­a­bil­i­ties in­to a new com­pa­ny and fil­ing for Chap­ter 11 bank­rupt­cy, ac­cord­ing to court pa­pers filed late Thurs­day.

The pro­ce­dures will now head to bank­rupt­cy court in North Car­oli­na, halt­ing all law­suits and their re­spec­tive dis­cov­ery process­es. It’s a move that comes a few months af­ter the Wall Street Jour­nal and Reuters both re­port­ed J&J was ex­plor­ing this op­tion, and af­ter a fed­er­al judge said the process could move for­ward in Au­gust.

Had J&J not en­gaged in the new sub­sidiary’s Chap­ter 11, the pay­outs would not have been ten­able, it said in court doc­u­ments. As the law­suits have mount­ed, grow­ing to near­ly 40,000 claims, J&J said it’s spent al­most $1 bil­lion in de­fense costs in the last five years. Set­tle­ments and ju­ry-award­ed pay­ments, mean­while, reached as high as $3.5 bil­lion.

“[T]he costs as­so­ci­at­ed with the con­tin­ued lit­i­ga­tion of the claims for decades to come would have been sim­ply un­sus­tain­able,” the doc­u­ments read. “The sta­tus quo there­fore was un­ten­able, and this chap­ter 11 case is nec­es­sary to ap­pro­pri­ate­ly as­sess, re­solve, and ad­min­is­ter these claims in an ef­fi­cient and eq­ui­table man­ner.”

Al­though J&J it­self, the world’s biggest phar­ma com­pa­ny worth more than $420 bil­lion in mar­ket cap, did not de­clare bank­rupt­cy, it uti­lized a Texas law that al­lows li­a­bil­i­ties to be sep­a­rat­ed from as­sets in­to a new en­ti­ty. J&J’s sub­sidiary, called LTL Man­age­ment, was cre­at­ed sole­ly for the pur­pose of hold­ing the talc-re­lat­ed debts and pay­ing out cred­i­tors.

The process is known for­mal­ly as a di­vi­sion­al merg­er but col­lo­qui­al­ly — and de­ri­sive­ly by crit­ics — as a Texas two-step bank­rupt­cy. Sev­er­al com­pa­nies fac­ing as­bestos-re­lat­ed lit­i­ga­tion have used the ma­neu­ver to shield them­selves from Chap­ter 11 pro­ceed­ings.

The bar­rage of law­suits has stemmed from al­le­ga­tions that the com­pa­ny’s tal­cum-based ba­by pow­der prod­ucts con­tained harm­ful ma­te­ri­als, such as as­bestos, and J&J hid the in­for­ma­tion while con­tin­u­ing to mar­ket and sell. J&J has tak­en talc-re­lat­ed suits to court in the past, los­ing a Mis­souri case in 2018 when a ju­ry award­ed plain­tiffs more than $4.7 bil­lion in dam­ages.

J&J is al­so ap­peal­ing an­oth­er suit in which a Mis­sis­sip­pi court ruled against the com­pa­ny, pe­ti­tion­ing the Supreme Court in Au­gust to re­view the case. Ear­li­er this month, eight for­mer FDA of­fi­cials filed an am­i­cus brief sup­port­ing J&J, say­ing the low­er court’s de­ci­sion “threat­ens to up­end” the way the agency makes la­bel­ing de­ci­sions.

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.

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.”

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.