Joaquin Duato, J&J CEO (Amir Hamja/Bloomberg via Getty Images)

J&J coughs up $40.5M in New Hamp­shire opi­oid set­tle­ment, evad­ing up­com­ing tri­al

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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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Heat­ed oral ar­gu­ments at SCO­TUS hint at Sanofi-Re­gen­eron edge over Am­gen in patent spat

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?”

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

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.

Dave Yost, Ohio attorney general (AP Photo/Jay LaPrete, File)

Ohio at­tor­ney gen­er­al sues sev­er­al PBMs over an­titrust con­cerns

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.

Rep. Cathy McMorris Rodgers (R-WA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House com­mit­tee chair re­quests in­fo from FDA on fund­ing for tri­als in­volv­ing 'vi­ral ma­nip­u­la­tion'

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.”

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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