Di­a­betes gi­ant No­vo said to con­sid­er up to 3,000 lay­offs as US pric­ing storms gath­er: re­port

“Un­cer­tain and un­pre­dictable mar­kets” are forc­ing No­vo Nordisk to con­sid­er drop­ping its longterm fi­nan­cial tar­get and cut­ting 3,000 jobs from its glob­al work­force, ac­cord­ing to a lo­cal me­dia re­port.

Bors­en, a Dan­ish busi­ness news­pa­per, cit­ed anony­mous sources in re­port­ing that the gi­ant di­a­betes drug­mak­er plans to un­veil its cost-cut­ting pack­age along­side sec­ond quar­ter re­sults in Au­gust. Ac­cord­ing to the sources, the plan would in­clude an ad­just­ment of its growth fore­cast, which No­vo put at 5% as re­cent­ly as May.

The gath­er­ing wind­storms in the US on drug pric­ing, es­pe­cial­ly as they re­late to No­vo Nordisk’s bread and but­ter in­sulin prod­ucts, are re­port­ed­ly a con­cern lead­ing to the new plan; the com­pa­ny ac­knowl­edged last month these pres­sures would cut its 2019 sales by 1% or 2%.

“The neg­a­tive el­e­ment is the re­port on the long-term fi­nan­cial tar­get, be­cause if true that would mean some­thing has changed since May,” Syd­bank an­a­lyst Soren Lontoft Hansen told Reuters.

Lars Fruer­gaard Jør­gensen

A spokesper­son de­clined to com­ment on “spec­u­la­tions,” but point­ed out that CEO Lars Fruer­gaard Jør­gensen has pre­vi­ous­ly stat­ed in the me­dia that “we as part of our plans for 2019 will de­ter­mine how to make up for the ef­fect of the in­creased part D re­bates through, for ex­am­ple, in­creased sales and cost sav­ings.” The state­ment went on:

It’s pre­ma­ture to dis­cuss what these plans may look like, be­cause the Part D re­bate is on­ly one of many fac­tors that we need to take in­to ac­count when plan­ning for the fu­ture. We are op­er­at­ing in a dy­nam­ic en­vi­ron­ment that brings new chal­lenges and op­por­tu­ni­ties every day, which means we con­tin­u­al­ly as­sess and ad­just plans as need­ed. And when­ev­er we make im­por­tant de­ci­sions, we will com­mu­ni­cate them at the ap­pro­pri­ate time.

The re­port — which sent shares down 4% in pre-mar­ket trad­ing — comes as No­vo Nordisk has been pump­ing out bull­ish news for the past few months, in­clud­ing new col­lab­o­ra­tions on the stem cell ther­a­py front, a li­cens­ing deal in hema­tol­ogy, and en­cour­ag­ing da­ta paving a piv­otal path to obe­si­ty for its new­ly ap­proved GLP-1 di­a­betes drug semaglu­tide.

If the in­for­ma­tion is ac­cu­rate, though, it would mark the sec­ond time No­vo has dis­ap­point­ed in­vestors in two years.

The 5% growth pre­dic­tion that forms the base­line to­day was in fact half of what No­vo promised in­vestors back in ear­ly 2016. When it ditched the 10% guid­ance, its shares were bat­tered, falling by 19%. And that was on the heels of an an­nounce­ment that the com­pa­ny had to axe 1,000 staffers in its R&D or­ga­ni­za­tion.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.

Jeff Dachis, founder and CEO, One Drop

Q&A: One Drop founder Jeff Dachis, from dig­i­tal agency to healthtech en­tre­pre­neur, catch­es the wave again

Jeff Dachis knows how to pick a business wave — although it may be more accurate to say he knows how to create them. The founder and CEO of digital health platform One Drop is working to transform the industry with predictive analytics and sophisticated tools. Alongside partner Bayer, which has now invested enough to own a third of the company, Dachis and One Drop are advancing data-driven personalized self-care for chronic disease management.

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