Ok­la­homa judge finds J&J guilty for its role in the opi­oid epi­dem­ic — but shares spike on $572M fine

An Ok­la­homa judge on Mon­day found phar­ma gi­ant J&J guilty of help­ing lay the ground­work on a na­tion­wide epi­dem­ic of opi­oid ad­dic­tion, but on­ly fined the com­pa­ny $572 mil­lion — at the very bot­tom of the range an­a­lysts had set, which stretched up in­to the bil­lions.

The close­ly watched out­come will help cal­i­brate es­ti­mates of just what kind of li­a­bil­i­ty the multi­na­tion­al com­pa­ny faces for an epi­dem­ic the CDC says has cost the lives of hun­dreds of thou­sands of peo­ple through­out the coun­try.

For in­vestors, it was good news, as J&J shares spiked close to 4% on the guilty rul­ing.

Michael Ull­mann

The Ok­la­homa At­tor­ney Gen­er­al had ar­gued that J&J’s ag­gres­sive sales prac­tices cre­at­ed an over­sup­ply of opi­oids that drove the epi­dem­ic, while un­der­play­ing the dan­gers and hyp­ing the re­wards of opi­oids. J&J was the on­ly re­main­ing de­fen­dant, af­ter Te­va and Pur­due Phar­ma reached their own set­tle­ments with­out ad­mit­ting guilt.

Not sur­pris­ing­ly, J&J saw it dif­fer­ent­ly, say­ing the state’s case nev­er proved their con­tention that the com­pa­ny’s ac­tions had cre­at­ed a pub­lic nui­sance. Now they’re go­ing to ap­peal.

“Janssen did not cause the opi­oid cri­sis in Ok­la­homa, and nei­ther the facts nor the law sup­port this out­come,” said Michael Ull­mann, J&J’s gen­er­al coun­sel. “We rec­og­nize the opi­oid cri­sis is a tremen­dous­ly com­plex pub­lic health is­sue and we have deep sym­pa­thy for every­one af­fect­ed. We are work­ing with part­ners to find ways to help those in need.”

This case was con­sid­ered a bell­wether suit which could have a big im­pact on the hun­dreds of state and lo­cal cas­es that are be­ing jug­gled now, pre­sent­ing the pos­si­bil­i­ty of a mas­ter agree­ment that could reach past $100 bil­lion.

For its part, J&J ar­gued that it played — at most — a mi­nus­cule role in the epi­dem­ic in Ok­la­homa. The phar­ma gi­ant tried, with­out suc­cess, to get the case thrown out, ar­gu­ing it was pro­tect­ed by the First Amend­ment. 

Ok­la­homa AG Mike Hunter coun­tered by say­ing that J&J ex­ecs co­or­di­nat­ed their mar­ket­ing work on opi­oids with Pur­due for years. 

Pur­due’s own­ers, the Sack­ler fam­i­ly, came to a $270 mil­lion set­tle­ment deal with the state, which will be used to pay for a new drug re­search cen­ter.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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