Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Pur­due Phar­ma may soon be sign­ing off on a guilty plea and an $8 bil­lion-plus set­tle­ment to wrap up its con­tro­ver­sial role dis­trib­ut­ing Oxy­Con­tin.

The AP has the break­ing sto­ry this morn­ing.

Pur­due filed for bank­rupt­cy last year, along with In­sys and fol­lowed by Mallinck­rodt, as it nav­i­gat­ed its way through a bliz­zard of lit­i­ga­tion sur­round­ing Oxy, which trig­gered an epi­dem­ic of abuse around the coun­try.

Flag­ship Pi­o­neer­ing pipes new comms chief on board

Chris­tine Heenan

Flag­ship Pi­o­neer­ing has re­cruit­ed a new chief of com­mu­ni­ca­tions, and they’re bring­ing her in as a se­nior part­ner.

Chris­tine Heenan, pres­i­dent and founder of the Claren­don Group, was tapped for the post at the big biotech VC, which spe­cial­izes in spin­ning out am­bi­tious biotechs with grand vi­sions and the bank ac­count to back it up.

She’s be­ing brought on “to shape the or­ga­ni­za­tion’s glob­al brand strat­e­gy, com­mu­ni­ca­tions and ex­ter­nal af­fairs,” ac­cord­ing to Flag­ship. And she will re­port di­rect­ly to the head hon­cho him­self, Noubar Afeyan.

As­cen­t­age bur­nish­es can­cer drug prospects as Chi­nese reg­u­la­tors put olverem­bat­inib in the fast lane

As­cen­t­age Phar­ma has won a pri­or­i­ty re­view from Chi­nese reg­u­la­tors for its drug treat­ing chron­ic myeloid leukemia.

Yi­fan Zhai

The drug is olverem­bat­inib (or HQP1351), which the com­pa­ny de­scribes as the first third-gen­er­a­tion BCR-ABL in­hibitor in Chi­na.

Yi­fan Zhai, the CMO at As­cen­t­age Phar­ma, not­ed: “This pri­or­i­ty re­view grant­ed to olverem­bat­inib will help ex­pe­dite the ap­proval process, hope­ful­ly soon chang­ing the cur­rent treat­ment op­tions for pa­tients with CML in Chi­na who can­not be ef­fec­tive­ly treat­ed by cur­rent­ly avail­able TKIs. We hope olverem­bat­inib will soon be ap­proved to ben­e­fit more pa­tients.”

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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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 clinicaltrials.gov, 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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