J&J re­grets pay­ing for study that in­ject­ed in­car­cer­at­ed Black men with as­bestos — re­port

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.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.