J&J has agreed to shell out $40.5 mil­lion to set­tle New Hamp­shire state’s al­leged claims over the com­pa­ny’s role in fu­el­ing the US opi­oid cri­sis.

The state sued the com­pa­ny in 2018 al­leg­ing that J&J’s sub­sidiaries “ag­gres­sive­ly mar­ket­ed” opi­oid painkillers and false­ly de­clared them as safer than al­ter­na­tives. The ac­cu­sa­tion in­clud­ed that J&J pro­mot­ed the false con­cept of pseudoad­dic­tion, which refers to des­per­ate drug-seek­ing that is caused not by true drug ad­dic­tion, but rather by un­der­treat­ment of pain. In ad­di­tion, the state al­leged the sub­sidiaries mis­rep­re­sent­ed that the opi­oids were rarely ad­dic­tive when used for chron­ic pain.

The state al­so al­leged the com­pa­ny mar­ket­ed opi­oids to doc­tors and pa­tients, mis­rep­re­sent­ing their ad­dic­tive prop­er­ties to treat chron­ic pain, and tar­get­ing vul­ner­a­ble groups like the el­der­ly, even though opi­oid use among the el­der­ly car­ries a height­ened risk of over­dose, in­jury and death.

J&J said it took the set­tle­ment step in or­der to “re­solve” the up­com­ing tri­al which was set to be­gin on Sep­tem­ber 12 in Mer­ri­mack Coun­ty, New Hamp­shire.

“This set­tle­ment is not an ad­mis­sion of li­a­bil­i­ty or wrong­do­ing and marks con­tin­ued progress in re­solv­ing opi­oid-re­lat­ed claims and lit­i­ga­tion by states, cities, coun­ties, and oth­er sub­di­vi­sions in the Unit­ed States. The Com­pa­ny will con­tin­ue to de­fend against any lit­i­ga­tion that the fi­nal agree­ment does not re­solve,” the com­pa­ny said in a press re­lease.

Un­der the terms of the agree­ment, the com­pa­ny will pay $39 mil­lion, plus an ad­di­tion­al $1.5 mil­lion for which it will be re­im­bursed from the na­tion­wide set­tle­ment fund be­cause New Hamp­shire did not par­tic­i­pate in that set­tle­ment.

The state said it had de­cid­ed to stay out of the na­tion­al set­tle­ment as the opi­oid cri­sis in New Hamp­shire was par­tic­u­lar­ly se­vere and be­cause New Hamp­shire had al­ready de­vot­ed sig­nif­i­cant lit­i­ga­tion re­sources at the time the na­tion­al set­tle­ment was an­nounced.

“This res­o­lu­tion pro­vides a pos­i­tive step for­ward in en­sur­ing these dev­as­tat­ing busi­ness prac­tices are not re­peat­ed,” Gov­er­nor Chris Su­nunu said in a state­ment.

The set­tle­ment im­pos­es a ban on J&J from sell­ing and man­u­fac­tur­ing opi­oids, a pro­mo­tion of opi­oids or opi­oid prod­ucts pre­scrip­tion sav­ings pro­grams.

In May, J&J an­nounced that it has reached a set­tle­ment with West Vir­ginia and agreed to pay $99 mil­lion to clear up claims spe­cif­ic to J&J’s al­leged role in the state’s opi­oid cri­sis.

Mean­while, J&J had al­ready reached a mas­sive set­tle­ment in­volv­ing dozens of states, throw­ing down $5 bil­lion along­side drug dis­trib­u­tors Amerisource­Ber­gen, Car­di­nal Health and McKesson in a $26 bil­lion deal meant to clear up most of any pend­ing lit­i­ga­tion.

WASHINGTON — Lawyers for Sanofi-Regeneron, Amgen, and the federal government took the stage at the Supreme Court on Monday, arguing a complicated patent case over the two sides’ competing, blockbuster PCSK9 inhibitors with justices’ questions hinting at a decision that will likely be a win for Sanofi and Regeneron.

The morning opened with about 45 minutes for Amgen’s lawyer, Jeffrey Lamken, who was peppered with straightforward questions from Associate Justices Clarence Thomas and Sonia Sotomayor, with Thomas at one point asking, “I’m confused as to what your invention is?”

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Ohio Attorney General Dave Yost is bringing a suit against several pharmacy benefit managers, accusing them of breaking a state antitrust act.

PBM consolidation, allowing a few companies to dominate the field, has created a “black box” that holds a “complex administration system” allowing these top PBMs to enrich themselves in various ways. This includes a “pay to play” rebate system pushing manufacturers to increase drug prices and to be placed on the preferred placement of PBM formularies, the suit alleges.

Republican members of Congress want FDA Commissioner Robert Califf and his agency to provide more information on the research FDA has funded that manipulates certain viruses like the SARS-CoV-2 virus — after the FDA confirmed that certain studies it funded involved viral manipulation, but in standard ways that are common in molecular biology.

The three-page letter, signed Monday by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chairs Brett Guthrie (R-KY) and Morgan Griffith (R-VA), kicked things off by saying that the committee was looking into FDA’s oversight of “FDA-funded research that may pose significant biosafety or biosecurity risks.”