Chop­ping close to home, No­var­tis out­lines plans to ax or move about 2,600 more jobs in an­oth­er wave of glob­al re­struc­tur­ing

No­var­tis is con­tin­u­ing its piece­meal plan to re­struc­ture the glob­al phar­ma com­pa­ny, once again bring­ing out the ax as it re­shapes its man­u­fac­tur­ing and ser­vices op­er­a­tions in Eu­rope this time.

Close to 2,200 jobs are be­ing elim­i­nat­ed in its home coun­try of Switzer­land in the next four years. That in­cludes rough­ly 1,500 staff at pro­duc­tion fa­cil­i­ties it runs in Basel, Stein, Lo­carno and Schweiz­er­halle. An­oth­er 700 ser­vice jobs in Basel — which is home — are be­ing re­dis­trib­uted to one of five glob­al cen­ters in Dublin, Hy­der­abad, Kuala Lumpur, Mex­i­co City and Prague.

At the same time, No­var­tis is clos­ing down a man­u­fac­tur­ing site at Grims­by in the UK, chop­ping close to 400 po­si­tions. 

These cuts will make way for new man­u­fac­tur­ing op­er­a­tions, which will add about 450 new Swiss jobs.

Vas Narasimhan

No­var­tis chair­man Jo­erg Rein­hardt has a hard earned rep as a re­lent­less econ­o­miz­er, a fact that new CEO Vas Narasimhan has had to work with just as Joe Jimenez did be­fore him. In the last few months we’ve seen the com­pa­ny punt its op­er­a­tions on ear­ly-stage re­search of an­tibi­otics while plan­ning to move its of­fi­cial head­quar­ters for Al­con from Fort Worth to Gene­va — a gam­bit de­signed to make it look more at­trac­tive as ex­ecs prep a spin­out of the unit, which nev­er worked out as planned.

Just days ago, No­var­tis al­so re­vealed plans to re­lo­cate 400 Dutch staffers from Arn­hem to Am­s­ter­dam, which will be the new head­quar­ters of the EMA. No­var­tis ex­ecs down­played any con­nec­tion with the reg­u­la­to­ry shift as the UK leaves the EU, pre­fer­ring to high­light its in­ter­est in the lo­cal sci­en­tif­ic com­mu­ni­ty.

Of­fi­cial­ly, all the cuts at No­var­tis has to do with what the chair­man sees as a new re­al­i­ty, with low­er drug prices in the US forc­ing stream­ing moves like this to main­tain prof­itabil­i­ty. In fact, No­var­tis has reg­u­lar­ly and rou­tine­ly been hunt­ing out sav­ings at the ex­pense of jobs for years, prun­ing R&D, man­u­fac­tur­ing and oth­er units in a glob­al re­or­ga­ni­za­tion that nev­er quite seems to end.

Im­age: Jo­erg Rein­hardt. NO­VAR­TIS

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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