Thai Public Health Minister Anutin Charnvirakul (Photo by Vachira Vachira/NurPhoto via AP)

Home­grown mR­NA Thai vac­cine for Covid-19 could be ready by year end — re­port

The Thai Food and Drug Ad­min­is­tra­tion will soon re­view tri­al re­sults from its coun­try’s first lo­cal­ly-de­vel­oped Covid-19 vac­cine, which us­es the same mR­NA tech­nol­o­gy that suc­cess­ful vac­cines from Pfiz­er/BioN­Tech and Mod­er­na have al­so em­ployed. If all goes well, Thai­land will roll out its first home­grown vac­cine by the end of this year, its gov­ern­ment has said.

The first lot of the vac­cine was pro­duced by BioNet-Asia, and de­vel­oped by Chu­la­longko­rn Uni­ver­si­ty re­searchers, the Bangkok Post re­port­ed. The jab, dubbed Chu­la­Cov19, has yet to be­gin clin­i­cal tri­als in hu­mans but ex­pects to lat­er this year, the Chu­la Vac­cine Re­search Cen­ter said. The cen­ter worked in col­lab­o­ra­tion with UPenn Pro­fes­sor Drew Weiss­man, who al­so worked on the mR­NA vac­cine tech that Pfiz­er/BioN­Tech de­ployed.

The vac­cine’s pro­duc­tion was spurred by a 2.31 bil­lion baht ($67 mil­lion) in­vest­ment from the gov­ern­ment last year.

BioNet-Asia can make 20 mil­lion dos­es a year. More than a dozen vac­cines are be­ing de­vel­oped, ac­cord­ing to Bloomberg, in an ef­fort to cut back re­liance on for­eign sup­ply. Chu­la­longko­rn’s is the most ad­vanced. Thai­land is al­so home to As­traZeneca’s on­ly man­u­fac­tur­ing site in south­east Asia.

Racha­da Dhnadi­rek

Deputy gov­ern­ment spokes­woman Racha­da Dhnadi­rek told the Bangkok Post that Thai­land’s goal of pro­duc­ing its own vac­cine aligns with its 10-year strate­gic plan to be­come a med­ical hub by 2026.

“The goal was set be­fore the Covid-19 pan­dem­ic be­gan, and by be­com­ing a vac­cine pro­duc­tion cen­ter, more Thai peo­ple will have ac­cess to the vac­cine,” she told the out­let.

Last Ju­ly, As­traZeneca ran in­to vac­cine dis­tri­b­u­tion is­sues in Thai­land and was forced to ask the gov­ern­ment for a five-month ex­ten­sion of the time­line to de­liv­er 61 mil­lion dos­es, bring­ing its dead­line all the way to this May. The hic­cup led Thai­land to re­port­ed­ly con­sid­er im­pos­ing ex­port bans on lo­cal­ly pro­duced dos­es of the jab, as waves of the virus hit its pop­u­la­tion hard.

Two weeks ago, the Quad Vac­cine Part­ner­ship hand­ed over a con­sign­ment of Cov­di-19 vac­cines from In­dia to the gov­ern­ment of Thai­land. More than 200,000 made-in-In­dia dos­es of Cov­o­vax were giv­en to the Min­is­ter of Pub­lic Health Anutin Charn­vi­rakul on April 21 in Bangkok.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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 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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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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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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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.

Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.