Peer Re­view: For­mer FDA Com­mish Califf will split his time be­tween Ver­i­ly and Duke

→ Af­ter a lit­tle over a year and a half at Al­pha­bet’s Ver­i­ly, neu­ro­sci­en­tist Dr. Thomas In­sel is join­ing the mys­te­ri­ous com­pa­ny’s ex­o­dus of tal­ent and call­ing it quits. In­sel ran the Na­tion­al In­sti­tute of Men­tal Health pri­or to his gig at Ver­i­ly. These days you can find him as the pres­i­dent and co-founder at a start­up called Mind­strong Health, which “has de­vel­oped and patent­ed a bio­mark­er pan­el that mea­sures brain func­tion from in­ter­ac­tion pat­terns cap­tured pas­sive­ly and con­tin­u­ous­ly from hu­man-com­put­er in­ter­faces found in ubiq­ui­tous mo­bile tech­nol­o­gy.”

Robert Califf

En­ter­ing the Ver­i­ly realm is Robert Califf. The ex-FDA com­mis­sion­er pre­vi­ous­ly worked with Ver­i­ly head An­dew Con­rad be­fore to head­ing up the agency. He’s al­so back at Duke Uni­ver­si­ty. “Af­ter con­clud­ing what has been an amaz­ing ex­pe­ri­ence as FDA Com­mis­sion­er, I’m ex­cit­ed to turn to a new ca­reer with Ver­i­ly and Duke Uni­ver­si­ty,” says Califf in his Ver­i­ly blog post.

→  Al­most ex­act­ly four years af­ter be­ing named per­ma­nent chief sci­en­tif­ic of­fi­cer at Bio­gen, Spy­ros Ar­ta­va­nis-Tsakonas has qui­et­ly left the com­pa­ny. The cell bi­ol­o­gy spe­cial­ist has been a pro­fes­sor at Har­vard Med­ical School since 1999. And now he’s head­ed back with fund­ing from Bio­gen on new re­search in­to neu­rode­gen­er­a­tive dis­eases. The big biotech gets an op­tion on li­cens­ing new tech from his lab in ex­change for the fund­ing.

→  For­mer Sarep­ta CEO Chris Garabe­di­an has won $15 mil­lion from some loy­al back­ers at Per­cep­tive Ad­vi­sors to es­tab­lish Xon­toge­ny, which promis­es to guide biotech star­tups through the first crit­i­cal stage of de­vel­op­ment lead­ing to proof-of-con­cept da­ta. Garabe­di­an is run­ning the show and he’s now re­cruit­ing a team.

Patrick Am­stutz has made the jump from in­ter­im CEO to the re­al deal. Am­stutz helmed Mol­e­c­u­lar Part­ners af­ter Chris­t­ian Zahn left the job late last year.

Ox­itec CEO Ha­dyn Par­ry is join­ing the moth­er ship. Par­ry has been bumped up to VP of cor­po­rate de­vel­op­ment, Eu­rope, the Mid­dle East, and Africa for In­trex­on. Look for Mark Carnegie-Brown to be in charge of Ox­itec as the new CEO.

→  Is­rael’s Al­co­bra said that CEO Yaron Daniely is step­ping down to head up the tech trans­fer arm at He­brew Uni­ver­si­ty.

Cy­tomX is shuf­fling the deck, with Bob Goetz ex­it­ing the CFO po­si­tion of the South San Fran­cis­co, CA-based biotech to “pur­sue new op­por­tu­ni­ties.” De­ban­jan Ray is now the new CFO and head of cor­po­rate de­vel­op­ment. “De­ban­jan has been in­stru­men­tal to Cy­tomX’s busi­ness suc­cess, in­clud­ing struc­tur­ing and ex­e­cut­ing col­lab­o­ra­tions that have re­sult­ed in more than $300 mil­lion in up­front and mile­stone pay­ments to date and to­tal po­ten­tial deal val­ue in ex­cess of $5 bil­lion,” said CEO Sean Mc­Carthy.

→ Ac­tini­um CEO Kaushik J. Dave and Chief Tech­nol­o­gy Of­fi­cer Dra­gan Ci­cic have both re­signed from the com­pa­ny


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 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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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.