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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.