New­ly un­sealed court doc­u­ments re­veal that John­son & John­son paid for a study that in­ject­ed 10 in­car­cer­at­ed Black men with as­bestos, as part of the com­pa­ny’s ear­ly tal­cum pow­der tri­als, ac­cord­ing to a new re­port in Bloomberg News.

Al­bert Klig­man

While news of the 50-year-old study it­self isn’t new, as it first came to light decades ago, J&J’s in­volve­ment in the hun­dreds of ex­per­i­ments con­duct­ed by a UPenn der­ma­tol­o­gist Al­bert Klig­man over two decades at Holmes­burg Prison in Penn­syl­va­nia is new, and will like­ly make a se­ri­ous dent in the Big Phar­ma’s rep­u­ta­tion.

The test­ing regime, ac­cord­ing to Bloomberg, was al­so fund­ed by Dow Chem­i­cal and the fed­er­al gov­ern­ment, and it sought to look in­to how as­bestos, a known car­cino­gen in the 1950s, com­pared with talc.

J&J didn’t dis­pute hir­ing Klig­man in the 1960s to do the ba­by pow­der tests, Bloomberg found, but J&J of­fi­cials said they re­gret­ted the firm’s in­volve­ment with the der­ma­tol­o­gist.

“We deeply re­gret the con­di­tions un­der which these stud­ies were con­duct­ed, and in no way do they re­flect the val­ues or prac­tices we em­ploy to­day,” Kim Mon­tagni­no, a com­pa­ny spokes­woman, said in an emailed state­ment to Bloomberg.

Ac­cord­ing to the un­sealed files, Klig­man re­cruit­ed 10 pris­on­ers in 1971 to get in­jec­tions of tremo­lite and chrysotile as­bestos, along with a talc shot in their low­er backs.

Mean­while, J&J late last month cel­e­brat­ed a win in bank­rupt­cy court, with a US judge rul­ing in fa­vor of its con­tro­ver­sial Chap­ter 11 fil­ing meant to set­tle thou­sands of law­suits al­leg­ing its talc-based prod­ucts caused can­cer.

J&J con­tin­ues to claim that its talc prod­ucts are safe, while the 38,000 law­suits claim that the wide­ly used ba­by pow­der and oth­er com­mer­cial talc prod­ucts con­tained as­bestos and caused mesothe­lioma and ovar­i­an can­cer.

Klig­man, mean­while, died in 2010, and ac­cord­ing to Bloomberg, nev­er ac­knowl­edged any wrong­do­ing. “My use of paid pris­on­ers as re­search sub­jects in the 1950s and 1960s was in keep­ing with this na­tion’s stan­dard pro­to­col for con­duct­ing sci­en­tif­ic in­ves­ti­ga­tions at the time,” Klig­man told the Bal­ti­more Sun in 1998.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.