Huntington Mayor Steve Williams (L) and Attorney General Patrick Morrisey (AP Photo/Leah M. Willingham)

West Vir­ginia judge rules in fa­vor of drug dis­trib­u­tors in opi­oid suit

Three ma­jor drug dis­trib­u­tors are off the hook for what may have been a $2.5 bil­lion pay­ment af­ter a fed­er­al judge found them not li­able for the opi­oid epi­dem­ic in parts of West Vir­ginia, one of the hard­est-hit ar­eas of the coun­try.

De­spite dis­trib­ut­ing more than 51.3 mil­lion dos­es of oxy­codone and hy­drocodone to phar­ma­cies in Ca­bell Coun­ty and the city of Hunt­ing­ton over less than a decade, McKesson, Amerisource­Ber­gen and Car­di­nal Health didn’t cause an over­sup­ply of opi­oids in the area, Judge David Faber ruled on Mon­day.

“Doc­tors, 99% of whom were act­ing in good faith, de­ter­mined the to­tal vol­ume of pre­scrip­tion opi­oids that phar­ma­cies or­dered from de­fen­dants and dis­pensed pur­suant to those pre­scrip­tions,” Faber wrote in his opin­ion.

The rul­ing fol­lows a months-long tri­al, in which pros­e­cu­tors ar­gued that the de­fen­dants cre­at­ed an opi­oid epi­dem­ic in Ca­bell Coun­ty and Hunt­ing­ton through their whole­sale dis­tri­b­u­tion of pre­scrip­tion opi­oids. The coun­ty and city were hit hard by the epi­dem­ic, with opi­oids ac­count­ing for more than 80% of over­dose deaths in Ca­bell Coun­ty from 2001 to 2018.

In 2017, more than 10% of peo­ple in Hunt­ing­ton, Ca­bell Coun­ty and Wayne Coun­ty were ad­dict­ed to opi­oids or had been in the past, ac­cord­ing to court doc­u­ments.

The state of West Vir­ginia tracked more than 6,000 over­dose deaths from 2001 to 2015, the doc­u­ments state. For­mer Bu­reau for Pub­lic Health com­mis­sion­er Rahul Gup­ta once called the state “ground ze­ro” for the na­tion­al opi­oid epi­dem­ic.

“The opi­oid cri­sis has tak­en a con­sid­er­able toll on the cit­i­zens of Ca­bell Coun­ty and the City of Hunt­ing­ton,” Faber wrote on Mon­day. “And while there is a nat­ur­al ten­den­cy to as­sign blame in such cas­es, they must be de­cid­ed not based on sym­pa­thy, but on the facts and the Law.”

Faber added that “there is noth­ing un­rea­son­able about dis­trib­ut­ing con­trolled sub­stances to ful­fill legal­ly writ­ten pre­scrip­tions.”

Mean­while, Hunt­ing­ton May­or Steve Williams said in an emailed state­ment that his “dis­ap­point­ment can­not be mea­sured.”

In their com­plaint, pros­e­cu­tors ac­cused the dis­trib­u­tors of sell­ing enough opi­oids in West Vir­ginia be­tween 2006 and 2014 to ac­count for “611 pain pills for every man, woman and child in the state.”

Plain­tiffs ac­cused the dis­trib­u­tors — as well as man­u­fac­tur­ers, phar­ma­cies and phar­ma­cy ben­e­fit man­agers — of en­gi­neer­ing “a dra­mat­ic shift in how and when opi­oids are pre­scribed” and fail­ing to main­tain ef­fec­tive con­trols.

“This case was al­ways about hold­ing these dis­trib­u­tors ac­count­able and pro­vid­ing our doc­tors, nurs­es, coun­selors, first re­spon­ders and so­cial work­ers with some of the re­sources need­ed to com­bat the opi­oid cri­sis,” Williams said in the state­ment. “We will work along­side our coun­sel to en­sure the fight con­tin­ues on be­half of so many who lost their lives and liveli­hoods to the opi­oid epi­dem­ic.”

The city and coun­ty sought $2.5 bil­lion from McKesson, Amerisource­Ber­gen and Car­di­nal Health to ad­dress the cri­sis, ac­cord­ing to a Reuters re­port. The state of West Vir­ginia opt­ed out of a $26 bil­lion set­tle­ment with the dis­trib­u­tors last year.

The state has since reached set­tle­ments with a suite of com­pa­nies for their role in the opi­oid epi­dem­ic, in­clud­ing J&J, which agreed to pay $99 mil­lion ear­li­er this year to clear up claims against it. Te­va and Al­ler­gan al­so struck a set­tle­ment with West Vir­ginia back in April, worth $161.5 mil­lion.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

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President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.