As­traZeneca culls its neu­ro­science team, ex­its Kendall Square of­fice

It turns out that As­traZeneca has been us­ing its prun­ing shears on staff in Cam­bridge, MA as well as down in Gaithers­burg, MD, where we re­port­ed last week that the com­pa­ny has been culling the ranks at Med­Im­mune as part of a com­pa­ny-wide ef­fort to shift more re­sources in­to on­col­o­gy.

In this case, it’s the neu­ro­science team that is feel­ing the ef­fects of the com­pa­ny’s ef­forts to “ap­pro­pri­ate­ly size” its glob­al R&D force.

The well-con­nect­ed blog­ger Derek Lowe, who has made a part-time job re­cent­ly out of spot­light­ing new rounds of re­search cuts at Mer­ck and As­traZeneca, was the first to spot the cuts af­ter pick­ing up fresh buzz about more lay­offs.

A spokesper­son for As­traZeneca tells me that they’re ex­it­ing an of­fice in Kendall Square – which is main­ly oc­cu­pied by the neu­ro­science team for iMed – and re­lo­cat­ing any of the staffers who will be stay­ing on at their op­er­a­tion in Waltham.

“I don’t have the num­ber, un­for­tu­nate­ly,” he added.

All of this is hap­pen­ing as a re­sult of the com­pa­ny’s plans, as they orig­i­nal­ly cit­ed in April, for the fol­low­ing ob­jec­tive:

“Sharp­en­ing of our fo­cus on our main ther­a­py ar­eas to pri­or­i­tize our pipeline and im­prove ef­fi­cien­cy and pro­duc­tiv­i­ty across the or­ga­ni­za­tion. This will see the com­pa­ny al­lo­cate ad­di­tion­al in­vest­ment to core ar­eas, par­tic­u­lar­ly on­col­o­gy.”

So don’t be sur­prised to hear about more such ef­fi­cien­cies at var­i­ous As­traZeneca op­er­a­tions.

Long­time As­traZeneca watch­ers will re­call that the phar­ma gi­ant cut way back on the neu­ro­sciences group four years ago, af­ter then R&D di­rec­tor Mar­tin Mack­ay was scram­bling to re­struc­ture the di­vi­sion and lay off more than 2,000 staffers in a last-ditch ef­fort to sat­is­fy an an­gry mob of an­a­lysts. Mack­ay was gone soon af­ter, (he now runs re­search at Alex­ion) but he left be­hind a 50-per­son “vir­tu­al” group in the Neu­ro­science In­no­v­a­tive Med­i­cines unit (iMed) charged with form­ing new aca­d­e­m­ic and in­dus­try al­liances in a ghost of its for­mer ef­fort on tough dis­eases of the brain.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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