French court finds Servi­er guilty of manslaugh­ter in di­et pill tri­al, fines phar­ma mil­lions

A French court found phar­ma com­pa­ny Servi­er guilty of de­cep­tion and manslaugh­ter Mon­day in one of the coun­try’s biggest health scan­dals.

The tri­al dealt with Servi­er’s di­a­betes drug Me­di­a­tor, or ben­flu­o­rex, which was pulled from shelves in France back in 2009 af­ter con­cerns it was re­lat­ed to a string of deaths and se­ri­ous side ef­fects. As part of the penal­ties, Servi­er was fined near­ly $3.2 mil­lion and a for­mer ex­ec­u­tive was sen­tenced to four years of a sus­pend­ed prison term, the Guardian re­port­ed.

France’s health med­i­cines agency was al­so fined about $350,000 for fail­ing to act quick­ly enough in re­gards to warn­ings.

Me­di­a­tor had been on the French mar­ket start­ing in 1976, billed as a way to ad­dress ex­cess weight in di­a­bet­ics. How­ev­er, the drug, an am­phet­a­mine-based ap­petite sup­pres­sant, was wide­ly pre­scribed as a di­et pill, in­clud­ing to many healthy women. Au­thor­i­ties es­ti­mate about 5 mil­lion took the drug over its 33-year lifes­pan.

Es­ti­mates range from 500 to 2,000 deaths among those who took the drug, on top of a whole host of in­di­vid­u­als com­ing down with se­ri­ous heart and car­dio­vas­cu­lar prob­lems. Re­ports had said be­fore the tri­al that many women found them­selves un­able to climb stairs as a re­sult of the side ef­fects.

Pros­e­cu­tors sought to de­ter­mine how long Servi­er knew about the po­ten­tial for side ef­fects and whether or not the phar­ma en­gaged in a coverup. Servi­er “know­ing­ly con­cealed the med­ica­tion’s true char­ac­ter­is­tics” as ear­ly as the 1970s, ac­cord­ing to the in­dict­ment.

The alarm was first raised by a French doc­tor in 2007, but con­cerns had lin­gered since the mid-1990s af­ter the re­moval of a sim­i­lar drug from the US in 1997. One doc­tor tes­ti­fied in the tri­al that he flagged is­sues as far back as 1998 but was pres­sured in­to re­tract­ing his find­ings, ac­cord­ing to the AP.

Me­di­a­tor was nev­er sold in the US or the UK, but did hit shelves in some Eu­ro­pean coun­tries like Switzer­land, Italy and Spain. Those coun­tries pulled the drug in the ear­ly 2000s.

When French reg­u­la­tors first an­nounced the drug was sus­pect­ed in the deaths, it sparked a na­tion­al out­rage and prompt­ed a se­ries of in­dus­try re­forms. Servi­er had ac­knowl­edged the deaths and said at the time it was work­ing on com­pen­sat­ing vic­tims, hav­ing hand­ed $146 mil­lion in pay­ments. It de­nied, though, charges that it mis­led the pub­lic and lied about Me­di­a­tor’s side ef­fects.

The tri­al in­volved about 6,500 plain­tiffs and 21 de­fen­dants stood tri­al, in­clud­ing 14 in­di­vid­u­als who ei­ther worked at Servi­er or were as­so­ci­at­ed with their mar­ket­ing of the drug. All told, Servi­er was found guilty of manslaugh­ter, in­vol­un­tary wound­ing and ag­gra­vat­ed de­cep­tion while be­ing ac­quit­ted of fraud.

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.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

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Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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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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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)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

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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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.