Richard Hatchett, CEPI CEO

Japan, UK pledge new funds to CEPI's $3.5B pan­dem­ic pre­pared­ness plan, with eye to­ward fu­ture out­breaks

As Covid-19 nears its in­evitable, slow-to-de­vel­op endgame, the na­tions of the world are look­ing to speed the pan­dem­ic’s end while prepar­ing for what comes next. A high­ly-tout­ed plan from CEPI to tur­bocharge pan­dem­ic R&D has earned the first of what it hopes will be sig­nif­i­cant fund­ing to take that ini­tia­tive for­ward.

With CEPI’s an­nu­al Glob­al Pan­dem­ic Pre­pared­ness Sum­mit just days away, the gov­ern­ments of the UK and Japan have pledged more than half a bil­lion dol­lars to the in­ter­na­tion­al ini­tia­tive as part of a five-year plan to end Covid-19 and pre­pare for fu­ture pan­demics.

CEPI’s am­bi­tious plan — dubbed the 100 Days Mis­sion — aims to speed the de­vel­op­ment of vac­cines and ther­a­peu­tics to 100 days for emerg­ing dis­eases. En­dorsed by the G7 and G20, the ini­tia­tive is look­ing to raise $3.5 bil­lion by the end of the sum­mit in ear­ly March.

For its part, the Japan­ese gov­ern­ment pledged $300 mil­lion to the ini­tia­tive, re­it­er­at­ing its sup­port for the in­ter­na­tion­al R&D strat­e­gy. In a state­ment, the gov­ern­ment said:

Japan will strength­en its co­op­er­a­tion with CEPI to re­spond to the cur­rent pan­dem­ic and pre­pare for fu­ture pan­demics. The con­tri­bu­tion to CEPI has great sig­nif­i­cance in ad­dress­ing the com­mon hu­man is­sue of pan­demics and can al­so help to fur­ther pro­mote Japan’s own vac­cine de­vel­op­ment and pro­duc­tion.

Mean­while, the UK pledged rough­ly $214 mil­lion to the mis­sion. The na­tion has raised around $370 mil­lion for the or­ga­ni­za­tion since 2018.

CEPI CEO Richard Hatch­ett had this to say about the pledges in a state­ment:

This fund­ing comes at a crit­i­cal mo­ment, al­low­ing CEPI to pur­sue our am­bi­tious pro­gram to de­vel­op ‘vari­ant proof’ vac­cines against Covid-19 and oth­er be­ta­coro­n­avirus­es as well as pur­sue our life-sav­ing work de­vel­op­ing vac­cines against the next Dis­ease X and known vi­ral threats such as Las­sa Fever, Ni­pah and Chikun­gun­ya.

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.

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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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.

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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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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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.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.