Ursula von der Leyen (AP Images)

Covid-19 roundup: Fac­ing sup­ply de­lay, UK fires shot at Eu­rope af­ter EU threat­ens to ban As­traZeneca vac­cine ex­ports

In the wake of Brex­it, lin­ger­ing ten­sion be­tween Britain and the EU has on­ly grown more pro­nounced with the bumpy roll­out of As­traZeneca’s Covid-19 vac­cine. Now, the for­mer mem­ber state is at odds with the con­ti­nent over ex­ports re­lat­ed to the shot.

Eu­ro­pean Com­mis­sion head Ur­su­la von der Leyen threat­ened on Wednes­day to ban EU ex­ports of Covid-19 vac­cines to Britain in or­der to en­sure mem­ber states had enough ac­cess, as the con­ti­nent is see­ing an emerg­ing third wave of the virus and more than a dozen Eu­ro­pean na­tions sus­pend­ed use of the As­traZeneca shot.

“We are still wait­ing for dos­es to come from the UK,” von der Leyen said, per Reuters. She lat­er added, “If this sit­u­a­tion does not change, we will have to re­flect on how to make ex­ports to vac­cine-pro­duc­ing coun­tries de­pen­dent on their lev­el of open­ness.”

That prompt­ed a harsh re­buke from British health min­is­ter Matt Han­cock, who as­sert­ed the UK has a le­gal right to the shots be­cause they helped fund, de­vel­op and set up the As­traZeneca sup­ply chain.

As­traZeneca has been in hot wa­ter for the last few months, af­ter say­ing ear­li­er this year that they would not be able to meet the num­ber of vac­cines orig­i­nal­ly promised in their con­tracts. Ad­di­tion­al­ly, re­ports of blood clots are caus­ing sev­er­al coun­tries — in­clud­ing Ger­many, Nor­way and Den­mark — to tem­porar­i­ly halt the roll­out of As­traZeneca’s Covid-19 vac­cine.

The tit-for-tat be­tween von der Leyen and Han­cock comes as the UK gov­ern­ment said Thurs­day that dis­tri­b­u­tion of the As­traZeneca/Ox­ford Uni­ver­si­ty shots will be slow­er than orig­i­nal­ly hoped due to a lack of sup­ply an­tic­i­pat­ed at the end of the month, ac­cord­ing to Reuters.

UK health of­fi­cials had not giv­en a rea­son for the slow­down, though As­traZeneca and Pfiz­er said that they’re both on sched­ule and their sup­ply chains are not ex­pe­ri­enc­ing any dis­rup­tion. But it emerged ear­ly Thurs­day that the short­fall is in part due to a de­lay in de­liv­ery from the Serum In­sti­tute of In­dia.

Per the BBC, a ship­ment of five mil­lion dos­es has been held up for at least four weeks. The goal had been to ship the vac­cines some­time this month, but there was no spe­cif­ic time out­lined for the de­liv­ery.

UK hous­ing sec­re­tary Robert Jen­rick told the net­work that nei­ther a sin­gle fac­to­ry nor a coun­try was re­spon­si­ble for sup­ply is­sues. He added that the coun­try’s goal to of­fer shots to every­one over 50 by April 15 will not be af­fect­ed by the de­lay.

But the UK is al­so draw­ing crit­i­cism for or­der­ing vac­cines from a com­pa­ny that is a promi­nent sup­pli­er of CO­V­AX, the or­ga­ni­za­tion pro­vid­ing vac­cines to low- and mid­dle-in­come coun­tries.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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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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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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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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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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

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.

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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