David Stack, Pacira Biosciences CEO

In high­ly un­usu­al move, Paci­ra sues med­ical jour­nal for li­bel over its non-opi­oid painkiller

A New Jer­sey biotech whose on­ly ap­proved drug is used as a painkiller af­ter surg­eries is su­ing a sci­en­tif­ic jour­nal, its ed­i­tors and a hand­ful of au­thors for li­bel af­ter the pub­li­ca­tion print­ed nu­mer­ous pa­pers and ed­i­to­ri­als that the com­pa­ny says dis­cred­it­ed the drug.

Paci­ra Bio­sciences filed the com­plaint against the Amer­i­can So­ci­ety of Anes­the­si­ol­o­gists in the US Dis­trict Court for New Jer­sey on Wednes­day af­ter­noon. A Feb­ru­ary is­sue of the group’s jour­nal Anes­the­si­ol­o­gy print­ed three ar­ti­cles and oth­er con­tent full of “bias” that “se­ri­ous­ly dis­par­aged” the drug Ex­par­el, Paci­ra claimed.

Fol­low­ing news of the law­suit late Wednes­day, Paci­ra $PCRX shares fell about 4.5% in Thurs­day trad­ing. The suit was first re­port­ed on the site Re­trac­tion Watch.

The ar­ti­cles, as well as a re­lat­ed pod­cast, “con­tain false and mis­lead­ing con­clu­sions, based on faulty sci­en­tif­ic re­search that does not sat­is­fy ap­plic­a­ble stan­dards with­in the sci­en­tif­ic com­mu­ni­ty,” Paci­ra wrote in the suit. “These con­clu­sions cre­ate the false im­pres­sion that EX­PAR­EL — a drug ap­proved by the FDA and used by over eight mil­lion pa­tients over the past nine years — is not an ef­fec­tive pain med­ica­tion.”

Evan Kha­rasch

Paci­ra said it suf­fered fi­nan­cial dam­ages re­lat­ed to the pa­pers, claim­ing that both cur­rent and prospec­tive cus­tomers have can­celed con­tracts or de­cid­ed against pur­chas­ing Ex­par­el. The biotech al­so al­leges that sev­er­al ed­i­tors and au­thors in­volved in the pub­li­ca­tion of the pa­pers in ques­tion failed to dis­close pay­ments from com­pet­ing com­pa­nies.

On top of that, Paci­ra claimed ed­i­tor-in-chief Evan Kha­rasch has for years fa­vored the use of opi­oid painkillers and used his po­si­tion to ad­vance a “pro-opi­oid agen­da” so as to vil­i­fy al­ter­na­tive med­i­cines. Ex­par­el is a non-opi­oid painkiller used as a re­gion­al anes­thet­ic af­ter surg­eries.

Among the three pa­pers in ques­tion was a meta-analy­sis that said Ex­par­el showed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in post-op pain com­pared to an­oth­er anes­thet­ic, but that the im­prove­ment was clin­i­cal­ly ir­rel­e­vant. Paci­ra said the analy­sis “cher­ry-picked se­lec­tive stud­ies that are like­ly to pro­vide an un­fa­vor­able view” of their drug and em­ployed a method known as “crude pool­ing” they say is wide­ly rec­og­nized as “flawed.”

There was al­so a pa­per ex­am­in­ing 76 ran­dom­ized con­trolled tri­als that said ev­i­dence did not sup­port the use of the drug, as well as an ed­i­to­r­i­al claim­ing the drug was not cost-ef­fec­tive.

Li­bel law­suits are no­to­ri­ous­ly dif­fi­cult to prove, giv­en the need to show both know­ing­ly pub­lish­ing or say­ing false state­ments, as well as in­tent to do rep­u­ta­tion­al harm. Com­pa­nies of­ten make threats or de­mand re­trac­tions of state­ments or pa­pers they view as un­fa­vor­able, but it’s un­clear how of­ten those threats are fol­lowed through with law­suits.

This is al­so not the first time Paci­ra has gen­er­at­ed con­tro­ver­sy, as they paid out $3.5 mil­lion to set­tle al­le­ga­tions over pay­ing doc­tors fraud­u­lent re­search grants to pre­scribe the drug be­tween 2012 and 2015, STAT re­port­ed at the time. Paci­ra al­so sued the FDA in 2014 af­ter the agency post­ed a warn­ing let­ter over the com­pa­ny’s mar­ket­ing prac­tices.

Ex­par­el was first ap­proved in 2011 in adults, and last month saw its la­bel ex­pand­ed in­to chil­dren over 6 years old.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Sanofi, Cel­lec­tis team up to pair Lem­tra­da with al­lo­gene­ic CAR-Ts; Bris­tol My­ers joins Evotec's dri­ve to ad­vance UK sci­ence

Sanofi is partnering up with Cellectis on their allogeneic CAR-Ts.

Cellectis struck a deal to use the French pharma’s drug alemtuzumab (Lemtrada, an MS agent) as part of its lymphodepletion regimen — used to sideline host immune cells and improve CAR-T cell expansion and persistence.

The Sanofi drug is already used in some clinical trials, and now the pharma giant is on the hook for clinical studies as they engage in negotiations over a commercial pact. — John Carroll

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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