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.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.