Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Sen­ate De­moc­rats are back­ing an FDA plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids as over­dose deaths have risen sharply over the past decade, with al­most 97,000 Amer­i­can opi­oid-re­lat­ed over­dose deaths in the past year alone.

While ac­knowl­edg­ing a de­cline in over­all opi­oid anal­gesic dis­pens­ing in re­cent years, the FDA said it’s re­con­sid­er­ing the need for manda­to­ry pre­scriber train­ing through a REMS giv­en the cur­rent sit­u­a­tion with over­dos­es, and is seek­ing in­put on the as­pects of the opi­oid cri­sis that manda­to­ry train­ing could po­ten­tial­ly mit­i­gate.

“In light of the many avail­able ed­u­ca­tion pro­grams and the lack of a na­tion­wide stan­dard, FDA is ex­plor­ing the val­ue of a sin­gle source for ed­u­ca­tion on the ap­pro­pri­ate use of opi­oids, on the risks of opi­oid abuse and mis­use, and on the treat­ment of opi­oid use dis­or­der to ad­dress mul­ti­ple needs and re­duce the bur­den on pre­scribers,” the agency said.

Cu­mu­la­tive­ly, from the end of Feb­ru­ary 2013 through May 15, 2021, FDA said more than 350,000 doc­tors have com­plet­ed pri­or ed­u­ca­tion cours­es, but that’s on­ly about one-third of the ap­prox­i­mate­ly 1 mil­lion pre­scribers of opi­oid anal­gesics in 2019.

“In ad­di­tion, al­though many pub­lic and pri­vate en­ti­ties have in­de­pen­dent­ly im­ple­ment­ed their own ed­u­ca­tion pro­grams and oth­er in­ter­ven­tions to en­cour­age safe and ef­fec­tive pre­scrib­ing prac­tices for opi­oid anal­gesics, there is no na­tion­wide stan­dard. There­fore, these pro­grams like­ly dif­fer with re­gard to con­tent, fo­cus, and du­ra­tion,” FDA said.

In of­fer­ing their sup­port for manda­to­ry pre­scriber ed­u­ca­tion on opi­oids, De­mo­c­rat Sens. Richard Durbin of Illi­nois, Richard Blu­men­thal of Con­necti­cut and Joe Manchin of West Vir­ginia made clear that it’s the di­rec­tion that they’d like to see FDA move in.

“Con­tin­u­ing a sys­tem of vol­un­tary pre­scriber ed­u­ca­tion for ad­dic­tive opi­oids would ig­nore the re­al­i­ty of: the on­go­ing pro­mo­tion by phar­ma­ceu­ti­cal sales rep­re­sen­ta­tives of pre­scrip­tion painkillers; how in­di­vid­u­als get hooked on hero­in and fen­tanyl; and the short­com­ings of the cur­rent pre­ven­tive reg­u­la­to­ry frame­work,” they wrote in a com­ment sub­mit­ted to the dock­et.

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.

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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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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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

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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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.

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.

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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